Genitourinary syndrome of menopause: Evaluation of symptoms,using a questionnaire,in a research setting,before and after treatment

Abstract

Background

Genitourinary syndrome of menopause (GSM) is a common condition, yet there is no defined, objective, and reproducible intervention with which to make a diagnosis. There are many different treatment options available, but without the correct diagnosis, affected women are unable to access the right therapy. This paper reports on the questionnaire arm of the VAN study (VAginal Health – What’s Normal?) which aimed to evaluate the performance and acceptability of the methods of assessment of GSM, described below.

Objectives

To determine the value of the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire: a multidimensional measure of the impact of vaginal symptoms on functioning and well-being in postmenopausal women, in a prospective, observational, feasibility study.

Methods

60 women were recruited to the study (20 premenopausal, asymptomatic women (control group) and 40 peri- and postmenopausal, symptomatic women). All women had a baseline assessment, using three different interventions, in addition to the DIVA questionnaire and symptomatic women were offered treatment, followed by a second assessment undertaken at 16 weeks, using the same interventions. This paper focusses on the outcomes for the questionnaire and specifically on the paired data sets, before and after treatment.

Results

An improvement in the score for all four sections of DIVA (Activities of daily living, Emotions, Sexual Activity, and Feelings about yourself and your body (female embodiment)) was observed, following any treatment. Additional questions were added to DIVA, to assess patient preference in relation to the different diagnostic interventions. These included a speculum examination as part of the clinical assessment, a smear taken from the lateral vaginal wall to assess the vaginal maturation index, both undertaken by a clinician and a self-administered tampon to collect vaginal secretions, to determine the small molecule metabolite profile, using NMR spectroscopy, and to enable analysis of the vaginal microbiome. The medical standard tampon was the preferred intervention, before and after treatment, for women eligible for treatment.

Conclusion

The VAN study demonstrates that DIVA, a previously tested questionnaire, is an easily accessible intervention, to assess the impact of urogenital symptoms on quality-of-life indicators in women in the United Kingdom with GSM and that women prefer to use a tampon themselves, rather than have a clinician performed vaginal speculum examination or a vaginal smear.

Keywords

Menopause urogenital atrophy assessment questionnaire

Introduction

Genitourinary syndrome of menopause (GSM) is defined as a condition affecting many menopausal women who experience genitourinary symptoms and who also have physical signs, detected on clinical examination.¹ The term vulvovaginal atrophy, which was previously commonly used, has been replaced with GSM, and future use of a single identifying term should help reduce confusion.² Symptoms of GSM are categorised in relation to how bothersome they are and the impact that they have on health-related quality of life indices. These include any impact on sex and relationships, confidence, and self-esteem. The Core Outcomes in Menopause Global Initiative, the COMMA Group, have developed a core outcome set (COS) to evaluate women with symptoms of GSM.³ This includes an assessment of the following criteria: pain with sex, vulvovaginal dryness, vulvovaginal discomfort or irritation, discomfort, or pain when urinating, change in the most bothersome symptom, distress, bother or interference in association with genitourinary symptoms, satisfaction with treatment, and side effects of treatment. It is hoped that this will ensure that the same information is gathered in clinical trials, enabling a meaningful comparison between results in different studies. However, lack of awareness, possibly linked to lack of education amongst clinicians, continues to delay diagnosis and access to appropriate treatment options for all women, and the true prevalence of GSM is thus unknown.²

Vaginal symptoms include dryness, itching, burning, and pain associated with sex. Urinary symptoms include frequency, nocturia, dysuria, urgency, and recurrent urinary tract infection.⁴ Affected women may assume that the symptoms they experience are due to ageing alone, as opposed to the impact of reduced levels of circulating estrogen on urogenital tissue quality, and as a result they may not seek to benefit from the range of available treatment options.⁵ Questionnaires are a common and important means of directly assessing the impact of symptoms on quality of life of women, and various examples exist in relation to the assessment of urogenital symptoms. A paper published in 2018, authored by Shifren et al,¹ recommended adoption of a novel patient-reported outcome measure (PROM), the Vulvovaginal Atrophy Questionnaire (VVAQ) for use in research following validation. However, a systematic review undertaken in 2019 to identify and assess existing resources for the measurement of PROMs for GSM recommended either the Vulvovaginal Symptoms Questionnaire⁶ or the Day-to-Day Impact of Vaginal Aging Questionnaire, DIVA.⁷ The COnsensus-based Standards for the selection of health Measurement INstruments, also known as the COSMIN,⁸ risk of bias checklist was used, and in the VAN study, VAginal Health – What’s Normal?, the DIVA questionnaire was identified as the best method to assess patient symptoms for the following reasons: Patients were involved in the development of DIVA, with items refined following interview pre-testing, and in addition, the PROM was field tested by ethnically diverse, symptomatic, postmenopausal women. Cronbach’s alpha was used to test for both internal consistency and for test–re-test reliability, with high scores (0.82–0.93), confirming consistency and accuracy. Correlations with other outcome measures to assess most bothersome symptom, sexual function, depression, and anxiety demonstrated a consistent interrelationship. DIVA is considered a trustworthy method with which to evaluate symptoms to assist in identifying women with GSM and to assess the impact of these symptoms in relation to function and well-being in four domains: activities of daily living, emotional well-being, self-concept and body image, and sexual functioning.⁹ DIVA is a brief, but comprehensive PROM with evidence of robust psychometric properties, including validity. This screening tool was developed in English but is also available in Spanish, Italian, Turkish, and German.^10–13 The higher the mean score (0–4), the greater the impact of symptoms. DIVA was originally developed in response to concern about lack of resources to assess urogenital symptoms and response to treatment; once diagnosed, affected women are eligible for treatment from a range of options. This is the first UK study to use the DIVA questionnaire to assess symptoms and response to treatment in women with GSM.

Aim

VAginal Health – What’s Normal? The VAN Study was designed to determine the most appropriate tools with which to diagnose GSM, including considering symptoms and vulvovaginal tissue quality, and to assess the concordance of the different tools studied. In parallel to the clinical research study, a systematic review of the literature was also undertaken to ascertain if a consistent diagnostic method exists for GSM. A recommendation of the systematic review was that use of a simple questionnaire, ideally including a question about most bothersome symptom, could improve the number of women diagnosed with and therefore eligible for treatment for GSM.

This research paper focusses specifically on the answers women gave to an adapted version of the DIVA questionnaire, before and after treatment for GSM, if treatment was recommended. Responsiveness to DIVA, before and after treatment, was analysed in tandem in the study. Additional questions were added to support the collection of demographic data and to assess patient preference in relation to the various diagnostic interventions used in the VAN study. The answers provided to the questionnaire were considered on the background of a presumed diagnosis of GSM and compared with the findings from the other assessment interventions, including an objective clinical examination, using a modified vaginal speculum with estimation of the pH of the vaginal secretions, a vaginal smear to assess maturation index and analysis of vaginal secretions, collected using a medical standard tampon, for the small molecule metabolite profile and the vaginal microbiome. The findings from the other interventions will be considered in subsequent papers. Huang et al have stated that a further assessment between the DIVA domain scales and other interventions would be helpful to ensure that DIVA achieves the goal it was designed for, which is to accurately diagnose and monitor women with GSM. The authors specifically site potential benefits associated with studies, such as the VAN study, which not only investigated symptoms, using the DIVA questionnaire, but also assessed clinical parameters and laboratory signs of GSM, whilst excluding other potential diagnoses.

Methods

Symptom assessment using a questionnaire was one of the main assessment modalities used in the VAN study. Data in relation to symptoms and symptom severity was collected using DIVA, a previously tested questionnaire (Supplemental Appendix 1). Additional questions were added to the DIVA questionnaire to provide information in relation to patient demographics and to assess patient preference with reference to the different diagnostic interventions. The scores for DIVA were compared with the assumed diagnosis of GSM at presentation, and the impact of treatment on the reported scores, reflecting responsiveness to the PROM, was subsequently reviewed. DIVA is described as a multidimensional self-report measure, covering 22 items, that can be completed in around 5 minutes. It was designed to assess the impact of vaginal symptoms on functioning, including sexual function, and well-being in postmenopausal women. Female sexual function was assessed using questions based on the Female Sexual Function Index¹⁴ and symptoms of depression and anxiety were assessed using an adaptation of the Hospital Anxiety and Depression Scale (HADS).¹⁵

Statistical analysis for the results of the VAN study was conducted using the IBM SPSS (Statistical Product and Service Solutions) software platform, version 27 for Windows.

Study design

VAN is prospective, observational, feasibility study (IRAS no: 288402, ethical approval LREC: 21/WA/0026), designed to evaluate concordance of different methods of assessment of vaginal health, compared with the current standard, a clinical assessment, before and after various commonly used treatments, as clinically indicated. Use of the adapted DIVA questionnaire was one of the outcome methods employed, and this paper provides an in-depth review of the impact of symptoms on day-to-day function, including sexual function, in women assumed to have GSM. The study design thus provided information on the most acceptable, objective, and reproducible methods to support the diagnosis and to monitor the response to treatment.

60 patients were recruited in total (20 premenopausal, asymptomatic women (control group) and 40 peri- and postmenopausal symptomatic women). Recruitment took place in gynaecology outpatient clinics in Liverpool Women’s Hospital (LWH), in the United Kingdom, by the Principal Investigator (PI). Patient information was provided (Supplemental Appendix 2) and written informed consent was obtained, at a subsequent appointment, from all women who agreed to participate in the study. The patients completed the DIVA questionnaire in the outpatient department, after the tampon had been inserted, providing participants with a 20-minute window to complete the questionnaire. Following an initial assessment, women were provided with individualised treatment plans, if needed. According to the standard practice for women attending the menopause and the vulval services at LWH, they were followed up 16 weeks after the initiation of the agreed treatment. 44 treated women were therefore assessed at both time points, (1) before and (2) 16 weeks after the initiation of treatment, providing paired data sets.

The psychometric responsiveness of DIVA was assessed, capturing change before and after treatment, described as Z scores (difference from the standard deviation) and minimum importance difference (MID).

To assess if the change in score after treatment was robust, the MID was estimated using a standardised formula, in which the post treatment value was subtracted from the baseline value and the difference was divided by the standard deviation of the baseline. If the value was greater than 0.3, the patient was considered to have reached the MID.¹⁶

Results

Participant demographics

The demographics of the study population are detailed in Table 1. More than 75% of the women studied were peri- or postmenopausal and 58% were sexually active. 21.7% of women were premenopausal, 10% perimenopausal, and 68.3% postmenopausal. There was very little ethnic diversity in the women recruited in the VAN study.

Table 1.

Participant demographics.

	Mean	SD
Age	50.4	13.25
BMI	27	6.68
	N	%
Menopause status
Pre	13	21.7
Peri	6	10
Post	41	68.3
Smoking status
Smoker	4	6.7
Non-smoker	36	60
Ex-smoker	20	33.3
Diet
Normal	47	78.3
Vegetarian	4	6.
Vegan	1	1.7
Avoidance	5	8.3
Other	3	5
Sexual activity
Sexually active	35	58.3
Not sexually active	12	20
N/A	13	21.7
Ethnicity
White British	41	68.3
White Other	10	16.7
Other	9	15.0
Education
GCSE and below	13	21.7
Further education	13	21.7
University degree and above	34	56.6

DIVA is a 22-item questionnaire, with four sections as follows:

Section A has five questions in relation to activities of daily living (score 0–4), Section B has four questions about the emotional impact of symptoms of GSM (score 0–4), Section C includes eight questions about sexual activity (score 0–4), and Section D has five questions exploring the impact of symptoms of GSM on self-esteem (score 0–4). The higher the score, the more severe the symptom(s). The original questionnaire had 23 questions, but two questions in Section C were merged to improve ease of use.

The mean scores for each question, in the questionnaire at baseline, and the mean scores at follow-up, after 16 weeks of treatment, in women with an assumed diagnosis of GSM, are shown in Table 2.

Table 2.

Paired participant responses to the 22 questions in DIVA – this table reflects the responses of women with an assumed diagnosis of GSM, who received treatment.

		Mean	N	SD	Mean difference	Cohen’s D	CI 95% of difference
Walk at your usual speed?	Before	2.00	46	1.282	0.457	1.17	0.062	0.673
Walk at your usual speed?	After	1.54	46	0.887
Wear the clothing or underwear you want?	Before	2.22	46	1.332	0.478	1.19	0.091	0.706
Wear the clothing or underwear you want?	After	1.74	46	0.953
Use the toilet or wipe yourself after using the toilet?	Before	2.26	46	1.163	0.674	1.18	0.257	0.896
Use the toilet or wipe yourself after using the toilet?	After	1.59	46	0.748
Sit for more than an hour?	Before	2.11	46	1.337	0.674	1.19	0.200	0.830
Sit for more than an hour?	After	1.43	46	0.720
Get a good night’s sleep?	Before	2.02	45	1.270	0.533	1.30	0.065	0.684
Get a good night’s sleep?	After	1.49	45	0.815
Depressed or down?	Before	2.93	46	1.181	0.674	0.97	0.306	0.954
Depressed or down?	After	2.26	46	1.219
Embarrassed?	Before	2.59	46	1.292	0.587	1.07	0.194	0.823
Embarrassed?	After	2.00	46	1.174
Frustrated or resentful?	Before	3.02	44	1.455	0.545	1.21	0.076	0.704
Frustrated or resentful?	After	2.48	44	1.355
Bad about yourself?	Before	2.64	33	1.410	0.485	1.39	−0.022	0.691
Bad about yourself?	After	2.15	33	1.372
Your desire or interest in having sexual intercourse or other types of sexual activity?	Before	3.63	43	1.543	0.814	1.58	0.122	0.765
Your desire or interest in having sexual intercourse or other types of sexual activity?	After	2.81	43	1.562
How frequently you had sexual intercourse or other types of sexual activity?	Before	2.87	31	1.500	0.839	1.93	−0.021	0.730
How frequently you had sexual intercourse or other types of sexual activity?	After	2.03	31	1.169
Your ability to become aroused during sexual activity?	Before	3.34	32	1.537	1.219	1.40	0.371	1.192
Your ability to become aroused during sexual activity?	After	2.13	32	1.264
Your ability to be spontaneous about sexual activity?	Before	3.29	28	1.584	1.107	1.53	0.253	1.091
Your ability to be spontaneous about sexual activity?	After	2.18	28	1.307
The amount of pleasure you experienced during sexual activity?	Before	3.00	27	1.441	0.741	1.32	0.081	0.897
The amount of pleasure you experienced during sexual activity?	After	2.26	27	1.403
Your desire or interest in being in a sexual relationship?	Before	3.09	43	1.461	0.791	1.78	0.077	0.714
Your desire or interest in being in a sexual relationship?	After	2.30	43	1.489
Affected your confidence that you could sexually satisfy a partner?	Before	3.14	42	1.646	0.619	1.47	0.068	0.712
Affected your confidence that you could sexually satisfy a partner?	After	2.52	42	1.642
Affected your overall satisfaction with your sex life?	Before	3.58	33	1.415	0.545	1.61	−0.099	0.617
Affected your overall satisfaction with your sex life?	After	3.03	33	1.510
My vaginal symptoms make me feel like I’m getting old	Before	3.76	45	1.433	0.222	1.23	−0.114	0.489
My vaginal symptoms make me feel like I’m getting old	After	3.53	45	1.531
I feel undesirable because of my vaginal symptoms	Before	3.20	46	1.500	0.435	1.37	0.010	0.616
I feel undesirable because of my vaginal symptoms	After	2.76	46	1.594
When I think about my vaginal symptoms, I feel like I have lost something	Before	3.82	44	1.419	0.568	1.27	0.076	0.704
When I think about my vaginal symptoms, I feel like I have lost something	After	3.25	44	1.587
My vaginal symptoms make me feel like my body is deteriorating	Before	3.71	45	1.424	0.133	1.27	−0.226	0.372
My vaginal symptoms make me feel like my body is deteriorating	After	3.58	45	1.545
I feel less sexy because of my vaginal symptoms	Before	3.70	40	1.471	0.400	1.32	−0.066	0.581
I feel less sexy because of my vaginal symptoms	After	3.30	40	1.539

Table 2 highlights the improvement (reduction in numerical value) in mean score between pre- and post-treatment responses.

Table 2 includes the mean, standard deviation, Z score, and N (sample size) for each question from the DIVA questionnaire, before and after treatment. Women were assessed at separate time points: baseline (before treatment) and at 16 weeks (after treatment). For each of the paired data sets, the mean difference, Cohen’s D, and the 95% confidence interval of the difference are provided. An improvement is demonstrated between baseline and re-assessment at 16 weeks for all questions in the DIVA questionnaire. A higher mean difference suggests a greater improvement in score, associated with an improvement in symptom control. The Cohen’s D value, associated with the difference, gives an indication of the power of the difference. Values exceeding 1.3 suggest a very strong effect, while those between 0.8 and 1.3 suggest a strong effect.

Confidence intervals are included in the last two columns.

Supplemental Appendix 3 provides further details of symptom scores before and after treatment.

Below is a more detailed analysis of each section of the questionnaire and the results, which highlight where the change in score, following treatment, is significant.

Activities of daily living

Part A: of the questionnaire considered the impact of vaginal symptoms on the ability of women participating in the study to undertake normal activities of daily life, including walking at a normal speed, wearing desired clothing, using the toilet, sitting for more than an hour, or getting a good night’s sleep in the previous 4 weeks. There was a significant reduction in the mean scores recorded for women, with an assumed diagnosis, after treatment, in all the questions in this section. This indicates an improvement in symptom control. DIVA is a useful PROM with which to objectively assess whether treatment is associated with an improvement in symptom control.

Emotions

Part B: This section considered the impact of vaginal symptoms, experienced in the previous 4 weeks, including dryness, soreness, irritation, or itching.

How women felt because of these symptoms was assessed by the following questions: Have the symptoms made you feel depressed or down, embarrassed, frustrated, resentful, or bad about yourself? The responses mostly demonstrated an improvement in symptoms following treatment.

Sexual activity

Part C: The questions in this section, related to sexual activity, had a variable level of response, in comparison to the other sections. Of the responders, there was an improvement in the score recorded between the initial and review assessment for all questions apart from the question about the impact of symptoms on your overall satisfaction with your sex life.

Not all the women responded to the questions relating to sexual activity. The actual numbers who responded to each section are shown in brackets below. During the last 4 weeks, have vaginal symptoms such as dryness, soreness, irritation, or itching affected your desire or interest in having sexual intercourse or other types of sexual activity (43), how frequently you had sexual intercourse or other types of sexual activity (31), your ability to become aroused during sexual activity (32), your ability to be spontaneous about sexual activity (28), the amount of pleasure you experienced during sexual activity (27), your desire or interest in being in a sexual relationship (43), your confidence that you could sexually satisfy a partner (42) and your overall satisfaction with your sex life (33).

Feelings about yourself and your body (female embodiment)

Part D: This was assessed by the relevance of the following statements to the women in the study:

‘My vaginal symptoms make me feel like I’m getting old; I feel undesirable because of my vaginal symptoms; when I think about my vaginal symptoms, I feel like I have lost something; my vaginal symptoms make me feel like my body is deteriorating and I feel less sexy because of my vaginal symptoms’. Although scores improved in all questions in this section, the mean scores demonstrated an improvement only in the question relating to women feeling that they have lost something because of their vaginal symptoms.

The MID was reached for daily living (51.1%), for psychological impact (57.6%), and for sexual impact (60%), but not for self-esteem (39.5%).

Figure 1 represents the findings described in Table 2 and clearly demonstrates an improvement (reduction in score) in all categories with treatment.

Figure 1.

Impact of treatment on the response to the four main areas covered in the questionnaire.

Patient preference to diagnostic methods before and after treatment

The modified DIVA questionnaire requested responses relating to the preferred vaginal assessment methods used by participants, before and after treatment. The speculum was consistently the least favoured intervention, whilst the tampon remained the most preferred (Figure 2).

Figure 2.

Patient preference in relation to diagnostic method before and after treatment, for the tampon, smear from the lateral vaginal wall, and the speculum.

Discussion

This study provides data on symptoms related to GSM from a population of women seen in a large tertiary referral centre in the United Kingdom. The results demonstrate the potential benefits, associated with use of a previously tested questionnaire, in assessing patient response to different treatments. The modified questionnaire also secured information on the patient preference of three different diagnostic methods, before and after treatment, demonstrating that a self-administered vaginal tampon is the preferred method choice for this population.

Widespread adoption of this self-report screening tool, in both primary and secondary care, has the potential to significantly improve the identification of symptomatic menopausal women, including women from a wide range of backgrounds, and will help facilitate provision of appropriate treatment.^17,18 In the VAN study, DIVA was considered as a holistic PROM, focusing on all aspects of daily living, including sexual function. Although there are various questionnaires that assess menopausal symptoms, including MENQOL and the Greene Climacteric Scale, few focus specifically on genitourinary symptoms or the impact that these symptoms can have on quality of life. The Urogenital Atrophy Quality of Life Questionnaire predates DIVA and is a tested method of symptom assessment, which was used to assess women with vaginal soreness and itching in the United Kingdom and Sweden.¹⁹ However, it has not yet been adopted either as a research method or into mainstream clinical practice. The DIVA questionnaire was developed to address the impact of vaginal dryness, soreness, itching, irritation, and pain on daily functioning and well-being, and the questionnaire was tested during development, across a range of ethnically diverse women. Our study population consisted mainly of Caucasian women, reflecting to an extent our local population, but also difficulties engaging with ethnic minority groups.¹⁷ In addition, the DIVA questionnaire specifically helps to address symptoms of GSM related to sexual activity, an area which has been highlighted, due to the difficulty women find raising this subject, particularly later in life.²⁰ Whilst loss of female sexual function can have a negative impact on relationships, the impact of GSM is more far-reaching, adversely affecting women’s quality of life, irrespective of engagement in sexual relationships.²¹ Future studies should assess use of the DIVA questionnaire in more ethnically diverse populations within the United Kingdom.

Availability of reliable tools that can accurately evaluate GSM symptoms before and after any treatment is essential for better patient care and for robust research, assessing efficacy of treatment. Huang et al, while developing the DIVA questionnaire, aimed to devise a resource that improved evaluation of response to treatments, including new treatment options for GSM. By employing the DIVA questionnaire, the VAN study evaluated its use in assessing response to treatment, in a group of symptomatic women with an assumed diagnosis of GSM, demonstrating promising results. However, in symptomatic women, there remains the need for a reliable method with which to make a clinical diagnosis. It is also important to rule out other potential diagnoses such as lichen sclerosus, lichen planus, and vulval cancer. In addition to symptom assessment, other more objective assessment methods are needed, based on tissue integrity and molecular composition, to target more effective treatments. In parallel to improving diagnostic methods, it is essential to understand the preferred type of assessment that can be used to diagnose or screen for GSM, from a patient perspective. The VAN study reviewed the acceptance of different objective assessment tools, including an adapted vaginal speculum to facilitate an objective scoring system and use of a medical standard tampon to collect vaginal secretions, which will inform future studies. The lack of preference for the modified vaginal speculum in women with GSM likely reflects the reduction in tissue elasticity, and the associated discomfort experienced when the blades of the speculum are opened. This was predicted to be less problematic following treatment, as the questionnaire scores improved, but this was not the case. Most women preferred the use of the self-administered tampon as a diagnostic/screening tool for GSM and their acceptance further increased after treatment. This could have been due to familiarity with tampons (less embarrassing) and the beneficial effect of the treatment (increased vaginal elasticity) on using the vaginal tampon with cardboard applicator. Since the smear was taken following insertion of the speculum, it is more difficult to ascertain if the responses reflect the experience with speculum or not.

Limitations of the use of an adapted version of DIVA in the VAN study

This study explores use of the DIVA questionnaire in the Northwest of England. Most of the participants (68.3%) in the VAN study identified as White British and as such, important variations in the responses involving a more ethnically diverse participant set may have been missed. This single centre study demonstrates an important opportunity for further exploration in a future study, using a qualitative approach, involving the DIVA questionnaire. Further evaluating the use of this tool throughout the United Kingdom to assess the effect of GSM symptoms and their influence on the well-being of women is recommended, ideally with a larger and more ethnically diverse study population. The questions on sexual activity may not have been considered relevant for women, either not having sex through choice or not having sex because of the effect of GSM on urogenital tissue quality.

The treatment effect in study was assessed after a short duration (16 weeks) and whether the questionnaire is suitable for assessment beyond this time is yet to be confirmed.

The study was not designed to assess the health economic impact of using such a questionnaire in clinical practice, in women with GSM.

Strengths of the use of an adapted version of DIVA in the VAN study

DIVA is a previously published questionnaire that has already undergone robust testing, prior to its implementation in this research study. There are limited studies that explore the impact of urogenital symptoms on quality of life, in women with GSM, through tested tools and as such, this study adds to the existing knowledge base. The DIVA questionnaire offers an accessible, reproducible, and non-invasive way to explore important quality of life indicators in women affected by GSM. A patient group was invited to review the study design from the inception and despite the COVID pandemic, six symptomatic women, with a diagnosis of GSM, reviewed and commented on the questionnaire, the VAN study protocol and patient information sheet (Supplemental Appendix 3). Their recommendations, including changing the layout of the questionnaire, were adopted.

Conclusion

The results of the questionnaire arm of the VAN study have demonstrated that the DIVA questionnaire is an easily accessible, previously tested questionnaire, designed to measure the impact of vaginal symptoms, occurring because of the menopause, on quality-of-life indicators, including the impact of symptoms on activities of daily living, emotional well-being, sexual function, and self-concept and body image. The DIVA questionnaire can be used as a method to assess the symptomatic response to different treatments for GSM, and it has a place in future research and clinical practice. The findings from this study suggest the need for further research, to determine the most effective and objective clinical tool with which to diagnose GSM, to be used alongside the most bothersome symptom and the DIVA questionnaire. Participants’ views on the acceptability of the different GSM diagnostic tools are important, and more detailed evaluation, in future studies, is recommended.

Supplemental Material

Genitourinary syndrome of menopause: Evaluation of symptoms, using a questionnaire, in a research setting, before and after treatment

Supplemental Material for Genitourinary syndrome of menopause: Evaluation of symptoms, using a questionnaire, in a research setting, before and after treatment by Paula Briggs, Babu Karavadra, James Wyatt, Dharani K Hapangama and Steven Lane.

Supplemental Material

Genitourinary syndrome of menopause: Evaluation of symptoms, using a questionnaire, in a research setting, before and after treatment

Supplemental Material

Genitourinary syndrome of menopause: Evaluation of symptoms, using a questionnaire, in a research setting, before and after treatment

Footnotes

Contributorship

DH and PB conceived the study and were involved in protocol development and gaining ethical approval. PB was responsible for patient recruitment. DH, BK, JW, and SL contributed to data analysis. PB wrote the first draft of the manuscript. All authors reviewed and edited the manuscript and approved the final version of the manuscript.

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) received no financial support for the research, authorship, and/or publication of this article.

Correction (August 2024):

Article updated; please see for further details.

Ethical approval

LREC:21/WA/0026 (IRAS number: 288402).

Guarantor

PB.

ORCID iD

Paula Briggs

Supplemental material

Supplemental material for this article is available online.

References

Shifren

Zincavage

Cho

, et al. Womenʼs experience of vulvovaginal symptoms associated with menopause. Menopause 2019; 26(4): 341–349.

Briggs

Hapangama

. Urogenital atrophy: the “unknown factors” challenging current practice. Post Reprod Health 2021; 27(2): 109–120.

Lensen

Bell

Carpenter

, et al. A core outcome set for genitourinary symptoms associated with menopause: the COMMA (core outcomes in menopause) global initiative. Menopause 2021; 28(8): 859–866.

Sinha

Ewies

. Non-hormonal topical treatment of vulvovaginal atrophy: an up-to-date overview. Climacteric 2013; 16(3): 305–312.

Benini

Ruffolo

Casiraghi

, et al. New innovations for the treatment of vulvovaginal atrophy: an up-to-date review. Medicina (Kaunas, Lithuania) 2022; 58(6): 770.

Gabes

Knüttel

Stute

, et al. Measurement properties of patient-reported outcome measures (PROMs) for women with genitourinary syndrome of menopause: a systematic review. Menopause 2019; 26(11): 1342–1353.

Erekson

Yip

Wedderburn

, et al. The vulvovaginal symptoms questionnaire: a questionnaire for measuring vulvovaginal symptoms in postmenopausal women. Menopause 2013; 20: 973–979.

Mokkink

Prinsen

CAC

Bouter

, et al. The Consensus-based Standards for the selection of health Measurement INstruments (COSMIN) and how to select an outcome measurement instrument. Rev Brasileira Fisioterapia 2016; 20(2): 105–113.

Huang

Gregorich

Kuppermann

, et al. Day-to-Day impact of vaginal aging questionnaire: a multidimensional measure of the impact of vaginal symptoms on functioning and well-being in postmenopausal women. Menopause 2015; 22(2): 144–154.

10.

Palacios

González

Fernández-Abellán

, et al. Impact of vulvovaginal atrophy of menopause in Spanish women: prevalence and symptoms according to the EVES study. Sex Med 2019; 7(2): 207–216.

11.

Nappi

Seracchioli

Salvatore

, et al. Impact of vulvovaginal atrophy of menopause: prevalence and symptoms in Italian women according to the EVES study. Gynecol Endocrinol 2019; 35(5): 453–459. DOI: 10.1080/09513590.2018.1563883.

12.

Sert

Özgül

. Turkish day-to-day impact of vaginal aging questionnaire: reliability, validity and relationship with pelvic floor distress. Int Urogynecol J 2022; 33(11): 3093–3102.

13.

Gabes

Stute

Apfelbacher

. Validation of the German day-to-day impact of vaginal aging (DIVA) questionnaire in peri- and postmenopausal women. Maturitas 2021; 152: 79. DOI: 10.1016/j.maturitas.2021.08.039.

14.

Rosen

. The female sexual function index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther 2000; 26(2): 191–208.

15.

Snaith

Zigmond

Snaith

, et al. The hospital anxiety and depression scale with the irritability-depression-anxiety scale and the leeds situational anxiety scale: manual. Heslington: NFER-Nelson, 1994.

16.

Copay

Subach

Glassman

, et al. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J 2007; 7(5): 541–546.

17.

Melby

Sievert

Anderson

, et al. Overview of methods used in cross-cultural comparisons of menopausal symptoms and their determinants: guidelines for strengthening the reporting of menopause and aging (STROMA) studies. Maturitas 2011; 70: 99–109.

18.

Mastroianni

Thompson

Shifren

, et al. Improving the identification of genitourinary syndrome of menopause through the utilization of the Day-to-Day impact of vaginal aging questionnaire. Menopause 2020; 27(11): 1295–1301.

19.

Kenna

SPM

Whalley

Renck-Hooper

, et al. The development of a quality of life instrument for use with post-menopausal women with urogenital atrophy in the UK and Sweden. Qual Life Res 1999; 8(5): 393–398.

20.

Gott

Hinchliff

. Barriers to seeking treatment for sexual problems in primary care: a qualitative study with older people. Fam Pract 2003; 20(6): 690–695.

21.

Nappi

Kingsberg

Maamari

, et al. The CLOSER (CLarifying Vaginal Atrophy's Impact on SEx and Relationships) survey: implications of vaginal discomfort in postmenopausal women and in male partners. J Sex Med 2013; 10(9): 2232–2241.

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.64 MB

0.47 MB

0.52 MB