Feasibility,acceptability and effects of a group pelvic floor muscle telerehabilitation program to treat urinary incontinence in older women

Abstract

Introduction

Urinary incontinence (UI) is one of the most prevalent health concerns in women age 65 and over. The recommended first-line treatment for UI is individual pelvic floor muscle training (PFMT). However, healthcare systems worldwide are unable to meet the demand for this resource-intensive approach. Recently, the Group Rehabilitation Or IndividUal Physiotherapy (GROUP) trial showed that group-based PFMT was not inferior to individual PFMT to treat UI in older women, despite using fewer resources. This study aims to assess the feasibility, acceptability and effects on UI-related symptoms and associated quality of life (QoL) of an online adaptation of the GROUP program (teleGROUP) for UI in older women.

Methods and analysis

This pilot study will involve the recruitment of 32 older women with UI. Participants’ attendance to online sessions, adherence to weekly home exercises, and side effects, in addition to the physiotherapist's fidelity to the program delivery will be collected to evaluate the program's feasibility. Participants’ dropout rates, reasons for dropout, satisfaction and usability scores will be collected to evaluate the program's acceptability for participants. A survey will evaluate the program's acceptability for the physiotherapists. Additionally, at the end of the study, qualitative semi-structured interviews and focus groups will investigate further feasibility and acceptability. To measure the effects of teleGROUP, number of weekly leakages and percentage reduction will be the primary outcomes.

Keywords

Urinary incontinence telerehabilitation aged women's health

Introduction

Urinary incontinence (UI), defined as ‘any involuntary leakage of urine’,¹ is one of the most frequent health conditions in women age 65 and over.^2,3 Half of community-dwelling women in this age group suffer from UI, with 25% reporting severe symptoms, with over 10 episodes/week.^2–4 As the number of older people around the world is projected to double by 2050, the proportion of women age 65 and over will continue to grow accordingly.⁵ A corresponding increase in UI incidence and severity is thus anticipated, which in turn will increase the number of women requiring UI treatment. UI is considered a serious medical condition that affects other medical conditions.^6,7 It engenders significant psychosocial problems and can lead to a restriction in social and physical activities.^8,9 UI is also associated with poor self-rated health and impaired well-being.^10,11 It can also interfere with sexual relationships and quality of life (QoL), as well as increased nursing home admissions, and can thus seriously impede healthy aging.^7–14

The recommended first-line treatment for UI in women is individual pelvic floor muscle training (PFMT) (Level of evidence 1; Grade of recommendation A), an approach supported by international clinical practice guidelines^15–17 and findings from recent randomized controlled trials (RCTs).^18–21 Yet, this treatment appears to be a resource-intensive approach that healthcare systems in many countries are currently unable to meet. Despite the negative impact of UI and the evidence supporting the efficacy of PFMT, less than a third of older women with UI receive treatment.^22,23 The major barriers to implementing this treatment include the lack of adequate human and material resources to address this problem through individual physiotherapy sessions.^24–26

Recently, a non-inferiority RCT – the Group Rehabilitation Or IndividUal Physiotherapy (GROUP) trial (ClinicalTrials.gov, NCT02039830) – showed that group-based PFMT was not inferior to individual PFMT to treat UI in older women, despite using fewer resources and being more cost-effective.^27–29 However, with the worldwide COVID-19 pandemic, public health authorities prevented gatherings to stop the virus’ spread. These safety measures therefore limited the possibilities of in-person group intervention approaches, particularly for older women. This context highlighted the importance of providing online options, which could also benefit women living in rural or remote areas, where pelvic floor rehabilitation services are scarce, particularly in the winter season when weather conditions are not optimal.

Telerehabilitation, defined as the remote delivery of rehabilitation services using information and communication technology, has already offered promising results for the treatment of various orthopaedic and neurological conditions.^30–39 Therefore, with the ultimate goal of increasing the accessibility of continence care for older Canadian women through an online adaptation of an effective and less resource-intensive group-based PFMT program, this pilot study aims to: (1) assess the feasibility and acceptability of the online adaptation of the GROUP program (the teleGROUP program) for UI in women age 65 years and over; and (2) assess the effects of teleGROUP on UI-related symptoms and associated QoL in this population.

Methods

Study design

This pilot study will use a convergent mixed-method pre-post design with a quantitative and a qualitative components.

Eligibility criteria

Women will be eligible to participate if they meet the following criteria:

Aged 65 years or older. This age cut-off was used in other studies on UI.²¹ Older women show a different genitourinary profile than younger women, notably due to menopause and age-related muscle loss;⁴⁰

Are able to walk safely and autonomously without any mobility device;

Have stress or mixed UI, confirmed by the questionnaire for incontinence diagnosis⁴¹;

Have at least three urine leakages per week, persisting for three months or more^28,29;

Report no cognitive deficit (mini mental state examination (MMSE) score of 24/30 or more)⁴²;

Have internet access;

Understand French;

Accept to complete a gynaecological examination, a 7-day bladder diary and questionnaires; and

Provide informed consent.

Women with the following characteristics will be excluded:

Have risk factors known to interfere with PFMT or the evaluation of pelvic floor muscles (PFM), including chronic constipation^43,44 (as defined by the International Working Committee for Chronic Constipation),⁴⁵ important pelvic organ prolapse (Baden-Walker score > stage 2),⁴⁶ or any other comorbidities with a potential impact on treatment (i.e. diabetes, active cancer, respiratory conditions, etc)²⁸

Are currently taking medication for UI or that affects skeletal muscles²⁸;

Are considered severely obese with a body mass index over 35⁴⁷;

Had an active urinary or vaginal infection in the past three months²⁸;

Underwent a change in hormonal therapy in the past six months²⁸;

Received pelvic floor physiotherapy, underwent surgery or any other treatment for UI or pelvic organ prolapse in the past year.

Recruitment and sample size

Participants will be recruited through advertisements in community centres, newspapers, social media channels, a participant database, promotion through various relevant media, groups and associations, and referrals from collaborating gynaecology and urology clinics in three large hospitals in the Montreal metropolitan area. Pilot studies are not commonly required to include sample size estimations.⁴⁸ However, as this study aims to assess the effects of an intervention, sample size calculations estimated that a total sample of 32 older women with UI would be required to ensure a power of 1−β = 95% with an α error of 0.05 and an estimated effect size of 0.73²⁹ to detect a statistically significant difference in the number of urine leakages between PRE and POST, with a conservatively anticipated attrition rate of 15% based on previous studies.²⁹ These 32 older women will be divided into four cohorts of seven to nine participants.

Intervention

Physiotherapists with specialized training in pelvic floor rehabilitation will establish participants’ eligibility during an initial individual in-person evaluation session. They will also teach participants how to correctly contract their PFM through vaginal digital palpation.⁴⁹

Participants will then be invited to take part in an online adaptation of the GROUP program^28,29: the teleGROUP program, which is a 12-week online group-based PFMT program composed of 12 weekly one-hour training sessions that participants will be able to attend from their home. An experienced pelvic floor physiotherapist will deliver all sessions via the Zoom videoconference platform to groups of six to eight women. If needed, participating women will receive an introduction to Zoom and support via phone before starting the teleGROUP program. All participants will be provided with an exercise booklet detailing the various exercises and their progression from initiation to maintenance, and support material for 12 educational capsules.

Each weekly virtual session will begin with a one to three-minute individual exchange between the physiotherapist and each participating woman in a private breakout room to discuss UI episodes and exercise adherence for the previous week. In the meantime, the rest of the group will socialize in the ‘main room’ of the Zoom session. All virtual sessions will then be divided into a 10–15-min educational component, including motivational capsules to foster adherence, and a 30–45-min PFM exercise component. The educational component will cover various topics, including the anatomy of the pelvic floor, pathophysiology of incontinence, PFM pre-contraction, bladder control, voiding parameters and others, supported by educational documents, video and testimonials (see Appendix 1). The exercise component will include a progression over three phases lasting four weeks each, allowing for increasing difficulty in the duration, number of repetitions and position (from lying, to sitting, to standing)²⁸ of four PFM exercises. These four exercises will target strength, speed of contraction, endurance and coordination. At the end of each virtual training session, a functional exercise will integrate PFM contractions through a dance activity. Time permitting, participating women will also perform pelvic and abdominal muscle exercises. Figure 1 provides an overview of the virtual sessions. In addition to their attendance to the weekly sessions, participating women will also be asked to perform the same exercises individually at home, for a total of five days per week of PFMT for the duration of the intervention. Upon completion of the 12-week program, participants will be asked to practice a maintenance exercise regimen.

Figure 1.

Overview of the weekly one-hour sessions with the treating physiotherapist.

Outcomes and data collection

Data will be collected at four time points: before the intervention, after confirmation of eligibility (PRE1) with the physiotherapist, before the first session of the 12-week intervention (PRE2), after the 12-week intervention (POST) and six months after the end of the 12-week intervention (FOLLOW-UP). Data will also be collected throughout the program by the treating physiotherapist. Table 1 provides an overview of the data collection process of the study.

Table 1.

Overview of the schedule of the study’s enrolment, intervention components and assessments.

	Enrolment			Intervention and follow-up
TIMEPOINT	March 2021 to January 2022	0m		1m	2m	3m		9m
TIMEPOINT	March 2021 to January 2022	Eligibility visit/PRE1	Before program initiation/PRE2				POST	FOLLOW-UP
ENROLMENT:
Pre-screening telephone eligibility interview	X
Informed consent		X
In-person individual evaluation session with the evaluating physiotherapist		X
ELIGIBILITY ASSESSMENTS:
Mini mental state examination (MMSE)		X
PERFECT assessment scheme		X
Baden-Walker grading system		X
BASELINE ASSESSMENTS:
Vaginal atrophy index (VAI)		X
Montreal cognitive assessment (MoCA)		X
Sociodemographic and health data		X
INTERVENTION COMPONENTS:
Pelvic floor muscle contraction teaching (during the in-person individual evaluation)		X
Zoom introduction and phone support			X
12-week online group-based PFMT program + individual home exercise program
Maintenance exercise program
Quantitative component
FEASIBILITY ASSESSMENTS:
Attendance to weekly sessions (reach)
Integrity of the teleGROUP program elements (fidelity)
Adherence to weekly home exercises (dose)
Complications and side effects
Adherence to the maintenance exercise program								X
ACCEPTABILITY ASSESSMENTS:
Acceptability survey of the evaluating physiotherapists			X
Dropout rates and reasons for dropouts
Single-item satisfaction question							X	X
System usability scale (SUS)							X	X
EFFECTS ASSESSMENTS:
7-day bladder diary		X	X				X	X
7-day bladder diary (leakages only)
International consultation on incontinence questionnaire module on UI symptoms (ICIQ-UI) short form		X	X				X	X
International consultation on incontinence questionnaire module on quality of life (ICIQ-LUTS QOL)		X	X				X	X
Australian pelvic floor questionnaire (APFQ)		X	X				X	X
Atrophy symptom questionnaire (ASQ)		X					X	X
Geriatric self-efficacy index (GSE)		X					X	X
Broome pelvic muscle exercise self-efficacy scale (PMSES)		X					X	X
Online technologies self-efficacy scale (OTSES)		X					X	X
Adapted Dowell-Bryant incontinence cost index (DBICI)		X					X	X
Estimation of costs associated with treatment							X
Patient global impression of improvement (PGI-I)							X	X
Single-item satisfaction tool							X	X
Qualitative component
Treating physiotherapist's logbook
Semi-structured interviews with the treating physiotherapist							X
Focus group/semi-structured interviews with the participants							X

Quantitative data

Eligibility

A member of the research team will enquire about the inclusion and exclusion criteria for the participants during a pre-screening telephone interview. Subsequently, participants will undergo an individual in-person evaluation with a specialized physiotherapist, located in their area, to confirm their eligibility to the study. During this evaluation, the physiotherapist will ensure that each potential participant do not have cognitive deficit, as attested with a MMSE score of 24/30 or more⁴² and confirm the information collected during the telephone interview. The physiotherapist will also complete an intra-vaginal evaluation including:

The PERFECT assessment scheme to assess PFM function through digital vaginal palpation.^50,51 The PERFECT is an acronym with P for power of the PFM contraction, measured with the modified Oxford 6-point muscle strength scale during a maximal voluntary contraction (0–5 scale, with higher scores indicating a stronger contraction), E for endurance of the PFM contraction (maximal duration that a maximal voluntary contraction can be sustained, measured from 0 to 10 s), R for repetitions (the number of repetitions of the specific maximal voluntary contraction that can be achieved, measured from 0 to 10 contractions), F for fast contractions (measured as the number of fast ‘contract-relax’ maximal contractions), E for elevation of the posterior vaginal wall during the PFM contraction (yes/no), C for co-contraction of the lower abdominal muscles during the PFM contraction (yes/no), and T for timing, with the presence of synchronous involuntary contraction of PFM on coughing (yes/no). This scheme has shown high validity and a high correlation with a manometric perineometer (r = 0.79) and high test-retest reliability (r between 0.93 and 0.99).⁵⁰

The Baden-Walker grading system⁴⁶ to investigate the presence and stage of any pelvic organ prolapse, scored from 0 to 4, with higher scores indicating a more advanced stage. This score is frequently used in research⁵² and widely accepted in routine clinical contexts.⁵³

If the participant is ineligible based on any of these tests during the evaluation, the physiotherapist will stop the assessment and provide individualized counselling for the remaining allocated time.

Baseline data

If the participant is eligible, the physiotherapist will also complete an additional intra-vaginal evaluation test:

The vaginal atrophy index to assess vaginal atrophy with observations of the vulvovaginal area (overall score of 6–15, with lower scores indicating more severe symptoms of vaginal atrophy).⁵⁴ This measure is commonly used in clinical practice and research.⁵⁵

The physiotherapist will then pursue the evaluation to collect baseline data. They will report the participant's MoCA score^56,57 and collect sociodemographic and health data, including age, height, weight, socioeconomic status, medical history and medication, parity and obstetric history, duration of UI symptoms and general health characteristics.

Feasibility

To measure the feasibility of the teleGROUP program, the physiotherapist leading the teleGROUP program will record various implementation outcomes in a logbook throughout the program:

Attendance to weekly sessions by participating women (reach).⁵⁸

Integrity of the teleGROUP program elements delivered by the physiotherapist during each session (fidelity).⁵⁸

Adherence to weekly home exercises by participating women (dose),⁵⁸ as reported by the participant during the one-on-one exchange at the beginning of each session.

Complications and side effects reported by participating women.

At the six-month follow-up (FOLLOW-UP), participants will also be asked about their adherence to the maintenance exercise program.

Acceptability

To measure the acceptability of the teleGROUP program, physiotherapists evaluating the participants will answer a survey based on the Theoretical Framework of Acceptability (TFA),⁵⁹ using similar questions to those used in literature, adapted to the context of the study (see Appendix 2).^60,61

The dropout rates and reasons for dropout will also be collected throughout the intervention. Additionally, at the end of the 12-week PFMT intervention (POST) and at the six-month follow-up (FOLLOW-UP), participating women will rate their satisfaction with the program using a single-item tool (‘completely satisfied’, ‘somewhat satisfied’ or ‘not at all satisfied’)⁶² and fill the system usability scale (SUS) to describe their experience with the online group-based PFMT program (10 items, 0–100 overall score, with higher scores indicating a higher usability). The SUS is currently the most widely used standardized questionnaire for the assessment of perceived usability⁶³ and has demonstrated high internal consistency with Cronbach's alpha, between 0.85 and 0.91.⁶⁴

Clinical effects

To measure the clinical effects of the intervention on UI-related symptoms, participants will report on the following clinical data before the intervention (PRE1), before the first session of the online group-based PFMT program (PRE2), immediately after the 12-week PFMT intervention (POST), and six months after the end of the program (FOLLOW-UP):

The 7-day bladder diary, recording urine leakage, reasons for urine leakage and mictions.^65,66 The number of leakages, measured by the 7-day bladder diary, is considered one of the most reliable measures of success for UI treatment and has been widely used in this type of research.^67–69 Furthermore, the 7-day bladder diary has shown a high compliance rate.^66,68,70 The primary outcome measures will be the number of weekly leakages and their percentage reduction, recorded through the 7-day bladder diary between PRE and POST measurements. Participants will also record their leakage in a bladder diary throughout the program and report them weekly to the physiotherapist, during the one-on-one exchange at the beginning of each session.

The International consultation on incontinence questionnaire module on UI symptoms (ICIQ-UI) short form⁷¹: A four-item questionnaire evaluating UI symptoms (0–21 overall score, with greater values indicating increased severity). The ICIQ-UI is widely used and has shown a high convergent validity with urodynamic testing (kappa of 0.77 and correlation coefficient of 0.84)^72,73 and clinical diagnosis using both urodynamic testing and uroflowmetry.⁷⁴ It also showed high test-retest reliability (90% similarity and correlation coefficients ranging from 0.91 to 0.96).^72,74

The International consultation on incontinence questionnaire module on QoL (ICIQ-LUTS QOL)⁶⁷: a 20-item questionnaire evaluating QoL in UI patients (0–14 overall score with greater values indicating increasing problems). The ICIQ-LUTS QOL provides a detailed and robust measure to assess the impact of UI on QoL with a focus on social impacts of UI.⁷⁵ It has shown excellent test-retest reliability (correlation coefficient between 0.80 and 0.96).⁷⁵

The Australian pelvic floor questionnaire (APFQ): a questionnaire assessing multiple pelvic floor symptoms including bladder (0–45 scores), bowel (0–34 scores), sexual function (0–21 scores) and prolapse symptoms (0–15 scores), with greater values indicating increased severity of symptoms. The APFQ has shown high face validity according to healthcare professionals and high convergent validity with urodynamic testing and physician diagnosis.^76,77 It also demonstrated high test-retest reliability (80–100%), good internal consistency (Cronbach's alpha between 0.65 and 0.87) and excellent responsiveness.^76,78

In addition to UI-related symptoms, participants will also report other symptoms and indicators before the intervention (PRE1), immediately after the 12-week PFMT intervention (POST), and six months after the end of the online group-based PFMT program (FOLLOW-UP):

The atrophy symptom questionnaire (ASQ): a five question questionnaire investigating atrophy symptoms and their impact on daily life and sexual function (0–15 overall score, with greater values indicating increased severity).⁷⁹ It has shown excellent test-retest reliability (correlation coefficient of 0.85).⁸⁰

The geriatric self-efficacy index (GSE): a 12-item questionnaire to measure older adults’ level of confidence in avoiding urine leakage (0–120 overall score, with higher scores indicating higher level of self-efficacy). It has shown high responsiveness to change and its sensitivity of 75.1% and specificity of 78.2% in detecting changes in UI status make it a clinically useful tool.⁸¹

The Broome pelvic muscle exercise self-efficacy scale (PMSES): a questionnaire to measure the level of confidence in performing PFMT exercises (14 items with responses ranging from 0 to 100 for part A and nine items with responses ranging from 0 to 100 for part B, both with higher scores indicating higher level of confidence). An overall mean self-efficacy score will be calculated (also ranging from 0 to 100). This scale has shown high internal consistency (Cronbach's alpha of 0.97) and good test-retest reliability (correlation coefficients between 0.64 and 0.72).⁸²

The online technologies self-efficacy scale (OTSES)⁸³: a 29-item questionnaire measuring technology self-efficacy (30–120 overall score, with higher scores indicating lower self-efficacy). It has shown high internal consistency with Cronbach's alpha, between 0.91 and 0.95.^83,84

The adapted Dowell-Bryant incontinence cost index (DBICI): a measure of costs and expenses incurred by participants for UI care (i.e. incontinence products, associated treatments) and technology-related costs (i.e. internet connexion, device used).^28,85,86 This tool has shown high test-retest reliability with minimal differences between assessments on Bland-Altman's plots.⁸⁵ Transportation-related costs (distance in km × gasoline price at the time of intervention) for the participant's initial evaluation will also be calculated.

The physiotherapist's working hours and the fees associated with the technology used to lead the class will also be calculated to estimate the costs of the teleGROUP program.

Participants will fill two additional questionnaires after the 12-week online group-based PFMT program (POST) and six months after the program (FOLLOW-UP):

The patient global impression of improvement (PGI-I): A single-item global index used to measure improvement of urinary continence following PFMT on a 7-point scale that ranges from 1 (‘very much better’) to 7 (‘very much worse’). The PGI-I has shown acceptable convergent and discriminant validity for measuring outcomes in studies of behavioural treatment for UI.⁸⁷

Satisfaction with treatment: A single-item tool to capture satisfaction with treatment: ‘satisfied’ (does not need other treatments); ‘unsatisfied’ (would like another treatment for UI).⁶²

Throughout data collection, women will be offered sufficient time, and breaks as needed, in order to fill all questionnaires. Participants will be also adequately compensated for their time.

Qualitative data

The treating physiotherapist leading the online group-based PFMT program will write in a logbook throughout the intervention and at the end of each 12-week online group-based PFMT program, to document the intervention and the reasons for any deviation from the teleGROUP program and to reflect on their experience. At the end of the study, the physiotherapist will be interviewed in a semi-structured approach, using an interview guide developed from the seven dimensions of the TFA,⁵⁹ three of the five Consolidated Framework for Implementation Research (CFIR) domains⁸⁸ and additional open-ended questions on satisfaction.

Additionally, participating women will be invited to take part in focus groups at the end of each 12-week online group-based PFMT program via Zoom, or individual interviews if they are not available at the time of the focus group. During these focus groups and interviews, participants will be asked to describe their experience and discuss potential challenges and satisfaction with the program, using relevant observations from the physiotherapist's logbook as prompts when appropriate. The focus group guide was also developed using the seven dimensions of the TFA,⁵⁹ three of the five CFIR domains⁸⁸ and additional open-ended questions on satisfaction (see Appendix 3). All focus groups and interviews will be recorded and transcribed verbatim.

Data analysis and statistical methods

Quantitative data

Eligibility, baseline, feasibility and acceptability data will be tabulated and interpreted using descriptive statistics at each relevant time point, using means, medians, standard deviations and interquartile ranges for continuous variables and frequency distributions for categorical and binary variables, as appropriate.

As the negative binomial mixed model is well suited for this type of data,⁸⁹ we will use it to analyze the effects of the online group-based PFMT program on the primary outcome (urine leakage episodes on the 7-day bladder diary) and investigate the differences between the PRE1, PRE2 and POST values. To analyze the long-term effects of the PFMT program on the number of urine leakages, we will also investigate these differences by adding the FOLLOW-UP values to the model. Additionally, we will further explore the changes in the number of urine leakages over time through a repeated measures design by adding the weekly leakage values to the model.

If the data are normally distributed, one-way repeated analyses of variance (ANOVA) will investigate differences between the PRE1, PRE2, POST and FOLLOW-UP values for the secondary outcomes, which include ICIQ-UI, ICIQ-LUTS QOL, AFPQ, ASQ, GES, Broome's scale, OTSES scores and UI-associated cost data from the DBICI. If the ANOVA is significant, post-hoc paired-samples t-tests will identify which time points show differences. If the data are not normally distributed, a Friedman test will investigate any differences between the PRE1, PRE2, POST and FOLLOW-UP values. If the Friedman test is significant, post-hoc Wilcoxon signed-rank tests will identify which time points show differences.

Treatment costs, PGI-I scores and satisfaction findings will also be reported using descriptive statistics.

The statistical significance level of all statistical tests will be set at p < 0.05. All statistical analyses will be performed using R and SPSS, version 26.0.0.0.⁹⁰

Qualitative data

All focus groups’ and interviews’ verbatim will be analyzed by two reviewers using a qualitative data analysis software.^91,92 The transcripts will undergo a thematic analysis, following a hybrid deductive and inductive approach of coding.⁹³ The initial codes will be extracted from seven dimensions of the TFA⁵⁹ and three of the five domains included in the CFIR framework⁸⁸ to build a preliminary codebook. Additional codes will be added inductively throughout the thematic analysis in an iterative process, either as separate codes from the preliminary codebook or as an expansion of the existing codes into more precise sub-codes.⁹³

Data integration

The feasibility, acceptability and effects quantitative data will be integrated with the focus groups’ and interviews’ findings using joint displays, following a mixed-methods convergent design.^94,95 This approach allows combining data together through a table, with the feasibility, acceptability and effects findings as columns, and the participating women and their specific cohort as rows. Through this visual representation using greyscale colour codes, we will then attempt to identify patterns to explain any observed differences in the perceived feasibility and acceptability between the participating women or their cohort. Such mixed-methods designs are helpful to ‘draw out new insights beyond the information gained from the separate quantitative and qualitative results’.⁹⁴

Patient and public involvement

This research echoes the needs and priorities of older women, expressed in a Citizens Jury.⁹⁶ No patients were involved in the design of the study or recruitment to and conduct of the study.

Ethics and dissemination

The Ethics Committee Board of the Research Centre of the Institut universitaire de gériatrie de Montreal (CRIUGM) approved this study (CER VN 20-21-33) on 8 March 2021.

The research team will send the consent form to the participants by mail after their telephone eligibility evaluation. Each participant will provide informed consent during the individual in-person evaluation. Participants will have time to ask questions before giving consent.

To mitigate risks related to data confidentiality, participants will receive a study identification number. A separate password-protected encrypted file linking study identification numbers with contact information will be maintained for the duration of the study. Any interaction taking place within the class will remain confidential. Furthermore, the participating women will see the physiotherapist individually in a breakout room when discussing their private data. They will not have to disclose any personal information to the group.

Upon completion of the study, we will present the findings at academic and clinical conferences, and publish a peer-reviewed article. The results of this pilot study will inform the development of a larger RCT and support implementation efforts in clinical settings.

Strengths and limitations

This pilot study relies on a rigorous mixed-method design and uses validated standardized measurement tools. Consequently, it promises to offer rich and complete findings on the feasibility, acceptability and both short-term and long-term effects of an innovative PFM group telerehabilitation program for older women with UI.

However, it also has some limitations which must be mentioned. This study's specific inclusion and exclusion criteria and the intensive nature of the intervention could limit the generalizability of results to a wider population of older women with comorbidities and polypharmacy. However, by adopting the same criteria and outcome measures as those used in the GROUP trial,^28,29 it allows for the qualitative comparison of the effects of receiving the intervention online versus in-person in similar populations.

This pilot study also includes a limited sample size and no control group. This limits the strength of the conclusions on the potential effects of teleGROUP. However, by combining a feasibility and acceptability study with a pilot effect study, these findings will enable us to provide important supporting information required in the development of a larger RCT, notably power calculations needed to establish sample size. This work thus constitutes an essential step in the development of pelvic floor telerehabilitation in the province of Quebec and elsewhere.

Conclusions

This trial will pave the way for the assessment of an online group-based PFMT through an RCT, with the ultimate goal of improving access to continence care for all older women during the COVID-19 pandemic and beyond. Providing an online option for group-based PFMT would allow older women to receive safe UI treatment even during pandemic periods, and also increase accessibility for women living in rural or remote areas where pelvic floor rehabilitation services are unavailable or scarce. Online group-based PFMT is also useful for women, who may not be able to attend rehabilitation outside their home due to weather conditions or either their own or their partner's health conditions.

Supplemental Material

sj-pdf-1-dhj-10.1177_20552076221123720 - Supplemental material for Feasibility, acceptability and effects of a group pelvic floor muscle telerehabilitation program to treat urinary incontinence in older women

Supplemental material, sj-pdf-1-dhj-10.1177_20552076221123720 for Feasibility, acceptability and effects of a group pelvic floor muscle telerehabilitation program to treat urinary incontinence in older women by Mélanie Le Berre, Johanne Filiatrault, Barbara Reichetzer and Chantale Dumoulin in Digital Health

Supplemental Material

sj-pdf-2-dhj-10.1177_20552076221123720 - Supplemental material for Feasibility, acceptability and effects of a group pelvic floor muscle telerehabilitation program to treat urinary incontinence in older women

Supplemental material, sj-pdf-2-dhj-10.1177_20552076221123720 for Feasibility, acceptability and effects of a group pelvic floor muscle telerehabilitation program to treat urinary incontinence in older women by Mélanie Le Berre, Johanne Filiatrault, Barbara Reichetzer and Chantale Dumoulin in Digital Health

Supplemental Material

sj-pdf-3-dhj-10.1177_20552076221123720 - Supplemental material for Feasibility, acceptability and effects of a group pelvic floor muscle telerehabilitation program to treat urinary incontinence in older women

Supplemental material, sj-pdf-3-dhj-10.1177_20552076221123720 for Feasibility, acceptability and effects of a group pelvic floor muscle telerehabilitation program to treat urinary incontinence in older women by Mélanie Le Berre, Johanne Filiatrault, Barbara Reichetzer and Chantale Dumoulin in Digital Health

Footnotes

Contributorship

MLB, JF, BR and CD all made substantial contributions to the development or design of the study and the interpretation of data. MLB wrote the first draft of the protocol and CD, JF and BR then revised the content of subsequent drafts and agreed on the final version prior to submission for peer review.

Ethical approval

The Ethics Committee Board of the Montreal Geriatric University Institute Research Center (CRIUGM) approved this study (CER VN 20-21-33).

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Advisory Committee for Clinical Research (CAREC) of the Research Centre of the Institut universitaire de gériatrie de Montréal (CRIUGM), and the Réseau québécois de recherche sur le vieillissement.

Guarantor

CD.

Trial registration

ClinicalTrials.gov NCT05182632.

ORCID iD

Mélanie Le Berre

Supplemental material

Supplementary material for this article is available online.

References

Haylen

De Ridder

Freeman

, , et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn 2010; 29: 4–20.

Hannestad

Rortveit

Sandvik

, et al. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPINCONT study. J Clin Epidemiol 2000; 53: 1150–1157.

Milsom

Altman

Cartwright

, et al. Epidemiology of urinary incontinence (UI) and other lower urinary tract symptoms (LUTS), pelvic organ prolapse (POP) and anal incontinence (AI). In: Abrams

Cardozo

Wagg

, et al. (eds) Incontinence. 6th ed. Tokyo: ICS 2016, 2017, pp.15–108.

Herschorn

Corcos

Gajewski

, et al. Canadian urinary bladder survey: population-based study of symptoms and incontinence. Age (y) 2003; 18: 41–64.

United Nations Department of Economic and Social Affairs Population Division. World Population Ageing 2019: Highlights, New York, USA. https://www.un.org/en/development/desa/population/publications/pdf/ageing/WorldPopulationAgeing2019-Highlights.pdf (2019).

Faltin

D-L

. Épidémiologie et définition de l’incontinence urinaire féminine. Je Gynécol Obstét Biol Reprod 2009; 38: S146–S152.

Resnick

Yalla

Laurino

. The pathophysiology of urinary incontinence among institutionalized elderly persons. N Engl J Med 1989; 320: 1–7.

Hunskaar

Vinsnes

. The quality of life in women with urinary incontinence as measured by the sickness impact profile. J Am Geriatr Soc 1991; 39: 378–382.

Johnson

Kincade

Bernard

, et al. The association of urinary incontinence with poor self-rated health. J Am Geriatr Soc 1998; 46: 693–699.

10.

Lin

S-J

Salmon

, et al. The impact of urinary incontinence on quality of life of the elderly. Am J Manag Care 2005; 11: S103–S111.

11.

Melville

Fan

Rau

, et al. Major depression and urinary incontinence in women: temporal associations in an epidemiologic sample. Am J Obstet Gynecol 2009; 201: 490.e1–490.e7.

12.

Sen

Onaran

Aksakal

, et al. The impact of urinary incontinence on female sexual function. Adv Ther 2006; 23: 999–1008.

13.

Temml

Haidinger

Schmidbauer

, et al. Urinary incontinence in both sexes: prevalence rates and impact on quality of life and sexual life. Neurourol Urodyn 2000; 19: 259–271.

14.

Kwak

Kwon

Kim

. Health-related quality of life and mental health in older women with urinary incontinence. Aging Ment Health 2016; 20: 719–726.

15.

Robert

Ross

Farrell

, et al. Conservative management of urinary incontinence. J Obstet Gynaecol Can 2006; 28: 1113–1118.

16.

Bettez

Le Mai Tu

Corcos

, et al. 2012 Update: guidelines for adult urinary incontinence collaborative consensus document for the Canadian Urological Association. Can Urol Assoc J 2012; 6: 354–363.

17.

Abrams

Anderson

Apostolidis

, et al. Recommendations of the international scientific committee: evaluation and treatment of UI, bladder pain syndrome, POP and fecal incontinence. In: Abrams

Cardozo

Khoury

, et al. (eds) 6th Ed International consultation on urinary incontinence. 2. Plymbridge, UK: Health Publication Ltd, 2017, pp.2549–2619.

18.

Dumoulin

Cacciari

Hay-Smith

EJC

. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev 2018; 10: Cd005654.

19.

Elliott

de Bruin

Dumoulin

. Virtual reality rehabilitation as a treatment approach for older women with mixed urinary incontinence: a feasibility study. Neurourol Urodyn 2015; 34: 236–243.

20.

Kim

Yoshida

Suzuki

. The effects of multidimensional exercise treatment on community-dwelling elderly Japanese women with stress, urge, and mixed urinary incontinence: a randomized controlled trial. Int J Nurs Stud 2011; 48: 1165–1172.

21.

Sherburn

Bird

Carey

, et al. Incontinence improves in older women after intensive pelvic floor muscle training: an assessor-blinded randomized controlled trial. Neurourol Urodyn 2011; 30: 317–324.

22.

Dugan

Roberts

Cohen

, et al. Why older community-dwelling adults do not discuss urinary incontinence with their primary care physicians. J Am Geriatr Soc 2001; 49: 462–465.

23.

Johnson

II Kincade

Bernard

, et al. Self-care practices used by older men and women to manage urinary incontinence: results from the national follow-up survey on self-care and aging. J Am Geriatr Soc. 2000;48:894–902.

24.

The Canadian Continence Foundation. Incontinence: The Canadian perspective. 2014.

25.

The Canadian Continence Foundation. The Impact of Incontinence in Canada: A Briefing Document for Policy-Makers. 2014.

26.

Walker

. Curricular content on urinary incontinence in entry-level physical therapy programmes in three countries. Physiother Res Int 1998; 3: 123–134.

27.

Dumoulin

Morin

Danieli

, et al., (eds). Group physiotherapy compared to individual physiotherapy to treat urinary incontinence in older women: A non-inferiority randomized control trial. In: International continence society 49th annual meeting, Gothenburg, Sweden, 2019.

28.

Dumoulin

Morin

Mayrand

M-H

, et al. Group physiotherapy compared to individual physiotherapy to treat urinary incontinence in aging women: study protocol for a randomized controlled trial. Trials 2017; 18: 544.

29.

Dumoulin

Morin

Danieli

, et al. Group-Based vs individual pelvic floor muscle training to treat urinary incontinence in older women: a randomized clinical trial. JAMA Intern Med 2020; 180: 1284.

30.

Amatya

Galea

Kesselring

, et al. Effectiveness of telerehabilitation interventions in persons with multiple sclerosis: a systematic review. Mult Scler Relat Disord 2015; 4: 358–369.

31.

Appleby

Gill

Hayes

, et al. Effectiveness of telerehabilitation in the management of adults with stroke: a systematic review. PLoS One 2019; 14: e0225150.

32.

Kairy

Lehoux

Vincent

, et al. A systematic review of clinical outcomes, clinical process, healthcare utilization and costs associated with telerehabilitation. Disabil Rehabil 2009; 31: 427–447.

33.

Cramer

Dodakian

, et al. Efficacy of home-based telerehabilitation vs in-clinic therapy for adults after stroke: a randomized clinical trial. JAMA Neurol 2019; 76: 1079–1087.

34.

Hwang

Bruning

Morris

, et al. A systematic review of the effects of telerehabilitation in patients with cardiopulmonary diseases. J Cardiopulm Rehabil Prev 2015; 35: 380–389.

35.

Subedi

Rawstorn

Gao

, et al. Implementation of telerehabilitation interventions for the self-management of cardiovascular disease: systematic review. JMIR Mhealth Uhealth 2020; 8: e17957.

36.

Tousignant

Marquis

Pagé

, et al. In-home telerehabilitation for older persons with chronic obstructive pulmonary disease: a pilot study. Int J Telerehabil 2012; 4: 7–14.

37.

Tousignant

Mampuya

Bissonnette

, et al. Telerehabilitation with live-feed biomedical sensor signals for patients with heart failure: a pilot study. Cardiovasc Diagn Ther 2019; 9: 319–327.

38.

Marquis

Larivée

Saey

, et al. In-home pulmonary telerehabilitation for patients with chronic obstructive pulmonary disease: a pre-experimental study on effectiveness, satisfaction, and adherence. Telemed e-Health 2015; 21: 870–879.

39.

Maddison

Rawstorn

Stewart

RAH

, et al. Effects and costs of real-time cardiac telerehabilitation: randomised controlled non-inferiority trial. Heart 2019; 105: 122–129.

40.

Ouslander

Hepps

Raz

, et al. Genitourinary dysfunction in a geriatric outpatient population. J Am Geriatr Soc 1986; 34: 507–514.

41.

Bradley

Rahn

Nygaard

, et al. The questionnaire for urinary incontinence diagnosis (QUID): validity and responsiveness to change in women undergoing non-surgical therapies for treatment of stress predominant urinary incontinence. Neurourol Urodyn 2010; 29: 727–734.

42.

Tombaugh

McIntyre

. The mini-mental state examination: a comprehensive review. J Am Geriatr Soc 1992; 40: 922–935.

43.

Amselem

Puigdollers

Azpiroz

, et al.

Constipation: a potential cause of pelvic floor damage?

Neurogastroenterol Motil 2010; 22: 150–e48.

44.

Averbeck

Madersbacher

. Constipation and LUTS: how do they affect each other? Int Braz J Urol 2011; 37: 16–28.

45.

Lacy

Mearin

Chang

, et al. Bowel disorders. Gastroenterology 2016; 150: 1393–1407.e5.

46.

Baden

Walker

. Genesis of the vaginal profile: a correlated classification of vaginal relaxation. Clin Obstet Gynecol 1972; 15: 1048–1054.

47.

Hunskaar

. A systematic review of overweight and obesity as risk factors and targets for clinical intervention for urinary incontinence in women. Neurourol Urodyn 2008; 27: 749–757.

48.

Thabane

Chu

, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol 2010; 10: 1.

49.

Berghmans

Morkved

, et al., (eds). Evidence-based Physical Therapy for the Pelvic Floor: Bridging Science and Clinical Practice. 2nd ed. Churchill Livingstone: Elsevier, 2015: 111–116.

50.

Laycock

Jerwood

. Pelvic floor muscle assessment: the PERFECT scheme. Physiotherapy 2001; 87: 631–642.

51.

Laycock

Whelan

Dumoulin

. Patient assessment. In: Therapeutic management of incontinence and pelvic pain. London: Springer, 2008, pp.57–66.

52.

Muir

Stepp

Barber

. Adoption of the pelvic organ prolapse quantification system in peer-reviewed literature. Am J Obstet Gynecol 2003; 189: 1632–1635.

53.

Persu

Chapple

Cauni

, et al. Pelvic organ prolapse quantification system (POP-Q) - a new era in pelvic prolapse staging. J Med Life 2011; 4: 75–81.

54.

Leiblum

Bachmann

Kemmann

, et al. Vaginal atrophy in the postmenopausal woman. The importance of sexual activity and hormones. JAMA 1983; 249: 2195–2198.

55.

Weber

Limpens

Roovers

JPWR

. Assessment of vaginal atrophy: a review. Int Urogynecol J 2015; 26: 15–28.

56.

Pinto

TCC

Machado

Bulgacov

, et al.

Is the Montreal Cognitive Assessment (MoCA) screening superior to the Mini-Mental State Examination (MMSE) in the detection of mild cognitive impairment (MCI) and Alzheimer’s Disease (AD) in the elderly?

Int Psychogeriatr 2019; 31: 491–504.

57.

Nasreddine

Phillips

Bédirian

, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc 2005; 53: 695–699.

58.

Saunders

Evans

Joshi

. Developing a process-evaluation plan for assessing health promotion program implementation: a how-to guide. Health Promot Pract 2005; 6: 134–147.

59.

Sekhon

Cartwright

Francis

. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res 2017; 17: 1–13.

60.

Renko

Knittle

Palsola

, et al. Acceptability, reach and implementation of a training to enhance teachers’ skills in physical activity promotion. BMC Public Health 2020; 20: 1568.

61.

Keyworth

O’Connor

Quinlivan

, et al. Acceptability of a brief web-based theory-based intervention to prevent and reduce self-harm: mixed methods evaluation. J Med Internet Res 2021; 23: e28349.

62.

Pleil

Coyne

Reese

, et al. The validation of patient-rated global assessments of treatment benefit, satisfaction, and willingness to continue--the BSW. Value Health 2005; 8: S25–S34.

63.

Lewis

. The system usability scale: past, present, and future. Int J Hum–Comput Interact 2018; 34: 577–590.

64.

Bangor

Kortum

Miller

. An empirical evaluation of the system usability scale. Int J Hum–Comput Interact 2008; 24: 574–594.

65.

Addla S, Adeyoju A and Neilson D. Assessment of reliability of 1-day, 3–days and 7-days frequency volume charts. Eur Urol 2004; 3: 130.

66.

Locher

Goode

Roth

, et al. Reliability assessment of the bladder diary for urinary incontinence in older women. J Gerontol A Biol Sci Med Sci 2001; 56: M32–MM5.

67.

Bosch

, Initial assessment of urinary incontinence in adult male and female patients and patient-reported outcome assessment. In: Abrams

Cardoza

Khoury

, et al. (eds) 6th Ed International consultation on urinary incontinence. 1. Plymbridge, UK: Health Publication Ltd, 2017, pp.541–588.

68.

Nygaard

Holcomb

. Reproducibility of the seven-day voiding diary in women with stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2000; 11: 15–17.

69.

Yalcin

Peng

Viktrup

, et al.

Reductions in stress urinary incontinence episodes: what is clinically important for women?

Neurourol Urodyn 2010; 29: 344–347.

70.

Wyman

Choi

Harkins

, et al. The urinary diary in evaluation of incontinent women: a test-retest analysis. Obstet Gynecol 1988; 71: 812–817.

71.

Avery

Donovan

Peters

, et al. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn 2004; 23: 322–330.

72.

Rotar

Tršinar

Kisner

, et al. Correlations between the ICIQ-UI short form and urodynamic diagnosis. Neurourol Urodyn 2009; 28: 501–505.

73.

Hajebrahimi

Nourizadeh

Hamedani

, et al. Validity and reliability of the international consultation on incontinence questionnaire-urinary incontinence short form and its correlation with urodynamic findings. J Urol J 2012; 9: 685–690.

74.

Lim

Liong

Lau

, et al. Validity, reliability, and responsiveness of the ICIQ-UI SF and ICIQ-LUTSqol in the Malaysian population. Neurourol Urodyn 2017; 36: 438–442.

75.

Kelleher

Cardozo

Khullar

, et al. A new questionnaire to assess the quality of life of urinary incontinent women. BJOG 1997; 104: 1374–1379.

76.

Baessler

O’Neill

Maher

, et al. A validated self-administered female pelvic floor questionnaire. Int Urogynecol J 2010; 21: 163–172.

77.

Baessler

O’Neill

Maher

, et al. Australian Pelvic floor questionnaire: a validated interviewer-administered pelvic floor questionnaire for routine clinic and research. Int Urogynecol J 2009; 20: 149–158.

78.

Baessler

Mowat

Maher

. The minimal important difference of the Australian Pelvic Floor Questionnaire. Int Urogynecol J 2019; 30: 115–122.

79.

Davila

Singh

Karapanagiotou

, et al.

Are women with urogenital atrophy symptomatic?

Am J Obstet Gynecol 2003; 188: 382–388.

80.

Mercier

Morin

Reichetzer

, et al.

Genitourinary syndrome of menopause symptom severity and impact outcome measures: are they reliable and correlated?

Menopause 2019; 26: 659–664.

81.

Tannenbaum

Brouillette

Michaud

, et al. Responsiveness and clinical utility of the geriatric self-efficacy index for urinary incontinence. J Am Geriatr Soc 2009; 57: 470–475.

82.

Panel

. Development and testing of a scale to measure self-efficacy for pelvic muscle exercises in women with urinary incontinence. Urol Nurs 1999; 19: 259.

83.

Miltiadou

. Validation of the Online Technologies Self-Efficacy Scale (OTSES). Educational Resources Information Center (ERIC). 2000.

84.

Hodges

Stackpole-Hodges

Cox

. Self-efficacy, self-regulation, and cognitive style as predictors of achievement with podcast instruction. J Educ Comput Res 2008; 38: 139–153.

85.

Dowell

Bryant

Moore

, et al. Calculating the direct costs of urinary incontinence: a new test instrument. BJU Int 1999; 83: 596–606.

86.

Cacciari

LVL

Morin

Tousignant

, et al. Economic evaluation of group-based vs. individual pelvic floor physiotherapy for urinary incontinence in older women Gothenburg, Sweden. https://www.ics.org/2019/abstract/270 (2019).

87.

Yalcin

Bump

. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol 2003; 189: 98–101.

88.

Damschroder

Aron

Keith

, et al. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci 2009; 4: 50.

89.

Wing

Creasman

West

, et al. Improving urinary incontinence in overweight and obese women through modest weight loss. Obstet Gynecol 2010; 116: 284–292.

90.

Corp I. SPSS for Windows: Advanced Statistics, Version 23.0.0.2. Armonk, NY: IBM Corp, 2015.

91.

SR International Pty Ltd. NVivo qualitative data analysis Software. 2012.

92.

Provalis Research. QDA Miner Lite - free qualitative data analysis software, https://provalisresearch.com/products/qualitative-data-analysis-software/freeware/ (2020).

93.

Fereday

Muir-Cochrane

. Demonstrating rigor using thematic analysis: a hybrid approach of inductive and deductive coding and theme development. Int J Qual Methods 2006; 5: 80–92.

94.

Fetters

Curry

Creswell

. Achieving integration in mixed methods designs—principles and practices. Health Serv Res 2013; 48: 2134–2156.

95.

Guetterman

Fetters

Creswell

. Integrating quantitative and qualitative results in health science mixed methods research through joint displays. Ann Family Med 2015; 13: 554–561.

96.

Dumoulin

Gareau

Morin

, et al. Research priorities for elderly women with urinary incontinence: results of a citizens jury. NJ, USA: Wiley-Blackwell, 2012.

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