Five-year outcome after pelvic floor reconstructive surgery: evaluation using dynamic magnetic resonance imaging compared to clinical examination and quality-of-life questionnaire

Abstract

Background

Dynamic magnetic resonance imaging (dMRI) captures the entire pelvis during Valsalva maneuver and helps diagnosing pelvic floor changes after reconstructive surgery.

Purpose

To evaluate therapeutic outcome five years after reconstructive surgery using clinical examination, dMRI, and quality-of-life (QOL) questionnaire.

Material and Methods

Clinical examination, dMRI, and QOL questionnaire were conducted before surgery and in the follow-ups at 12 weeks, one year, and five years in women with pelvic organ prolapse (POP) stage ≥2. dMRI was performed at 1.5-T using a predefined protocol including sagittal T2-weighted (T2W) sequence at rest and sagittal T2W true-FISP sequence at maximum strain for metric POP measurements (reference points = bladder, cervix, pouch, rectum). Pelvic organ mobility (POM) was defined as the difference of the metric measurement at maximum strain and at rest.

Results

Twenty-six women with 104 MRI examinations were available for analysis. dMRI results mostly differ to clinical examination regarding the overall five-year outcome and the posterior compartment in particular. dMRI diagnosed substantially more patients with recurrent or de novo POP in the posterior compartment (n = 17) compared to clinical examination (n = 4). POM after five years aligns to preoperative status except for the bladder. POM reflects best the QOL results regarding defecation disorders.

Conclusion

A tendency for recurrent and de novo POP was seen in all diagnostic modalities applied. dMRI objectively visualizes the interaction of the pelvic organs and the pelvic floor after reconstructive surgery and POM correlated best with the women’s personal impression on pelvic floor complaints.

Keywords

Dynamic magnetic resonance imaging pelvic organ prolapse pelvic organ mobility quality-of-life questionnaire vaginal mesh repair

Introduction

Pelvic organ prolapse (POP) represents a major public health issue. Women with this disorder can suffer from a severely decreased quality of life (QOL), such as physical, emotional, and social distress often making surgical interventions unavoidable (1). While there are a number of classic surgeries known and well-practiced in urogynecology (e.g. vaginal or abdominal hysterectomy, colporrhaphy, or sacrocolpopexy), the past decade in urogynecological surgery was influenced by the use of alloplastic material when aiming for pelvic floor reconstruction (2,3). Yet, the use of mesh material in surgical POP treatment remains highly controversial (4). Heterogeneous outcome results regarding prolapse recurrences, mesh erosions, or dyspareunia have been presented by numerous study groups often evaluating clinical results within themselves or, when applying an imaging tool, with ultrasound (US) (5). Pelvic floor US, for example, has rapidly been optimized in its visualization technique over the past years (e.g. three- and four-dimensional (3D/4D) US technique) with revealing a great amount of detail (6 –8). However, it still has its limits as it cannot visualize all compartments at once, every so often being handicapped in complex prolapse situations and it is dependent on the experience and handling technique of its applicant (8). Dynamic magnetic resonance imaging (dMRI) is well-known to be able to capture the entire pelvis and its organs during Valsalva maneuver, allowing an objective view on pelvic organ interactions using a standardized protocol according to the current recommendations of the European Society of Urogenital Radiology and the European Society of Gastrointestinal and Abdominal Radiology (9). Because dMRI could play a role in the comprehensive evaluation of the postoperative pelvic floor after reconstructive surgery, we evaluated the medium-term follow-up results five years after vaginal mesh repair gained from clinical urogynecological examination (clinical examination), dynamic magnetic resonance imaging (dMRI), and prolapse quality-of-life (P-QOL) questionnaire. We present the surgical outcome evaluated by clinical examination as standard urogynecological procedure and focused on the evaluation of metric dMRI results compared to clinical examination and P-QOL.

Material and Methods

Study population

Between January 2008 and October 2009, 130 women were enrolled and registered into a prospective database as they received vaginal mesh repair due to a stage 3 or 4 or a symptomatic stage 2 prolapse according to the simplified pelvic organ prolapse quantification system (S-POP) (10,11). Institutional review board approval was obtained (IRB-number: S-473/2007. Amendment retrieved October 30th, 2012) and all women gave written informed consent. Due to the diagnosis made by clinical examination, an anterior, posterior, or combined anterior/posterior mesh repair was applied to repair POP (12). The patients were initially scheduled for five visits for clinical examination and dMRI, before and four times after surgery (at four weeks, 12 weeks, one year, and five years). At all visits, they were also asked to reply a validated QOL questionnaire that contains 34 questions, of which 18 questions concern the major symptoms of POP and 16 are grouped in nine domains related to particular aspects of life (12,13). Clinical examination included Graves speculum examination in the lithotomy position and documentation of POP during Valsalva maneuver (12). Recurrence was defined as S-POP ≥ stage 2 in women with the initial diagnosis of S-POP ≥ stage 2 regarding the same reference point. De novo POP was defined as S-POP ≥ stage 2 in women with initial S-POP stage 0 or 1 regarding the same reference point. dMRI was performed at 1.5-T (Magnetom Symphony, Siemens Medical Solutions, Erlangen, Germany) using a predefined protocol including a T2-weighted (T2W) high-resolution sequence in sagittal plane for morphologic information and measurements at rest and a T2W true-FISP sequence in sagittal plane during straining and at maximum strain for metric POP measurements (14). Evaluation of the validated P-QOL questionnaire was performed to assess the impact of vaginal mesh repair surgery on patients’ QoL (13,15). Subgroups of this database were previously analyzed and reported (12,14). In these, we concluded that there was no added value to the four-week follow-up with MRI compared to the 12-week follow-up (12,14). Based on this, we did not include the four-week data into this mid-term follow-up evaluation. Patients were eligible for this analysis of longitudinal mid-term follow-up results after vaginal mesh repair if the pre-surgical examination, as well as the 12-week, one-year, and five-year postsurgical examination triad (clinical examination, dMRI, and QOL questionnaire), was available.

MR measurements

To define POP on dMRI, the maximum organ descent was measured at maximum strain in reference to the pubococcygeal line (PCL) using the bladder neck (B), the anterior cervical lip or vaginal vault after hysterectomy (C), and the pouch of Douglas (P) as reference points, according to the ESUR recommendations (9). The measurement of the extent of an anterior rectal wall bulge (R) was performed according to a line drawn through the anterior wall of the anal canal (9). Metric measurements (in cm) are positive if the position of the reference point is below the PCL and negative if the position is above it (9,14). While clinical terminology defines S-POP stages, dMRI terminology defines POP grades (9,10). We used the grading system recommended by the ESUR (9). Recurrence was defined as POP grade ≥ 2 using the same criteria as defined for clinical examination. We additionally evaluated the therapeutic outcome detached from a grading system by analyzing the pelvic organ mobility (POM), which is defined as the difference of the metric measurement at maximum strain to the measurement at rest for each reference point (9,14). MR measurements were performed in consensus reading by readers with up to nine years of experience in pelvic floor MRI.

Statistical analysis

Wilcoxon signed rank tests were used to compare both the POP stages by clinical examination and the POP grades by dMRI of the different post-surgical visits to the preoperative status. In addition, POM and maximum organ descent derived by dMRI was compared between preoperative and post-surgical visits using t-tests. ANOVA was used to compare QOL domains between pre- and post-surgical visits. Continuous variables are presented as mean ± standard deviation. Distributions of stages/grades are described by absolute frequencies. Due to the explorative character of the study we did not adjust for multiplicity. Statistical analyses were performed using R, version 3.2.3 (R Foundation for Statistical Computing, Vienna, Austria).

Results

Twenty-six patients fulfilled the request of a complete examination triad at all visits during a five-year post-surgical period; therefore, 104 MRI examinations were available for analysis (Fig. 1). The mean age of this study cohort was 64 ± 10 years (range = 41–81 years). Mean body mass index (BMI) was 28.06 ± 6.43 kg/m².

Fig. 1.

Flowchart of the study cohort including mesh repair procedure.

Clinical urogynecological examination results

The S-POP stages derived by clinical examination changed significantly at the 12-week follow-up for all reference points and stayed significantly improved at the one-year as well as at the five-year follow-up (Tables 1 and 2). However, a recurrence was diagnosed at the five-year follow-up in 38% of patients (10/26), with one compartment involved in 90% and two compartments involved in 10%. De novo POP was diagnosed in 31% of patients (8/26), with one compartment involved in 75% and two compartments involved in 22% (Table 1). Three patients were diagnosed with a combination of recurrent and de novo POP (Table 1).

Table 1.

Urogynecological S-POP stage before surgery and five years after surgery.

Patient no.*	Bladder			Cervix/vaginal vault			Pouch of Douglas			Rectum
Patient no.*	Pre	5-year FU		Pre	5-year FU		Pre	5-year FU		Pre	5-year FU
1	3	0		2	0		3	0		0	0
2	3	0		0	0		0	2	d-n	0	1
3	3	2	r	0	0		0	1		0	1
4	4	1		4	0		4	0		4	0
5	0	2	d-n	4	2	r	0	0		0	2	d-n
6	3	0		3	0		0	0		2	2	r
7	3	2	r	3	0		0	0		2	0
8	3	0		2	0		0	0		2	0
9	2	2	r	3	0		1	0		1	0
10	3	0		3	0		3	0		0	0
11	3	1		1	0		0	0		1	2	d-n
12	3	2	r	1	3	d-n	3	0		1	1
13	3	0		0	0		0	0		2	0
14	3	2	r	0	0		0	0		1	1
15	3	1		0	0		0	0		2	2	r
16	3	1		0	3	d-n	0	0		0	0
17	3	1		0	0		3	1		3	0
18	2	3	r	3	2	r	1	1		1	0
19	3	0		3	0		3	0		2	0
20	0	0		0	0		1	0		3	0
21	1	2	d-n	1	0		3	0		3	0
22	2	0		0	0		0	0		3	0
23	0	1		0	0		3	0		3	1
24	1	1		2	0		0	0		3	0
25	0	2	d-n	0	0		3	0		3	1
26	0	2	d-n	0	2	d-n	3	0		3	2	r

Anterior mesh repair (patients 1–16), total mesh repair (patients 17–19), posterior mesh repair (patients 20–26).

Pre, before surgery; S-POP, simplified pelvic organ prolapse quantification system; FU, follow-up; r, recurrent POP; d-n, de novo POP.

Table 2.

S-POP stages gathered by clinical examination and POP grades gathered by dMRI are given for each reference point at all visits.

		CE (S-POP-stage)					dMRI (POP-grade)				P value* (pre surgery vs. FU)
Reference point	Visit	0	1	2	3	4	0	1	2	3	CE	dMRI
Bladder	Pre surgery	5	2	3	15	1	10	2	8	6	–	–
	12 weeks	19	6	1	0	0	15	11	0	0	<0.001	0.001
	1 year	12	8	6	0	0	12	13	1	0	0.001	0.007
	5 years	9	7	9	1	0	6	14	6	0	0.005	0.161
Cervix/Vaginal vault	Pre surgery	12	3	3	6	2	16	4	5	1	–	–
	12 weeks	25	0	0	1	0	24	2	0	0	0.002	0.005
	1 year	26	0	0	0	0	25	1	0	0	0.001	0.007
	5 years	21	0	3	2	0	19	5	2	0	0.028	0.122
Pouch of Douglas	Pre surgery	13	3	0	9	1	7	8	11	0	–	–
	12 weeks	24	0	1	1	0	14	10	2	0	0.003	0.001
	1 year	18	6	2	0	0	11	12	3	0	0.012	0.005
	5 years	22	3	1	0	0	12	8	5	1	0.003	0.057
Rectum	Pre surgery	6	5	6	8	1	8	9	8	1	–	–
	12 weeks	20	5	0	1	0	1	12	12	1	0.001	0.029
	1 year	17	8	1	0	0	4	7	15	0	<0.001	0.104
	5 years	15	6	5	0	0	1	12	13	0	0.003	0.083

Wilcoxon signed rank test using the individual not averaged POP stages/grades.

CE, clinical urogynecological examination; dMRI, dynamic magnetic resonance imaging; S-POP, simplified pelvic organ prolapse quantification system; POP, pelvic organ prolapse.

MRI results

The mean values of maximum organ descent improved statistically significantly at the 12-week and one-year follow-up, except for the measurements of rectal wall bulges (R) (Fig. 2). At the five-year follow-up, however, the measured values were approximately equal to the preoperative status; moreover, the mean values for rectal wall bulges were even worse than at the beginning (Fig. 2). The results regarding the POP grade distribution derived by dMRI also showed statistically significant improvement at the 12-week follow-up for all reference points and at the one-year follow-up except for rectoceles (Table 2). At the five-year follow-up, the POP grade distribution was no longer significantly improved for all reference points compared to the preoperative status (Table 2).

Fig. 2.

Development of pelvic organ decent over time assessed with dMRI.

A recurrence was diagnosed at the five-year follow-up in 38% of patients (10/26), with one compartment involved in 70% and two compartments involved in 30%. De novo POP was diagnosed in 46% of patients (12/26), with one compartment involved in 83% and two compartments involved in 17%. Five patients were diagnosed by dMRI with a combination of recurrent and de novo POP.

Focusing on the five-year follow-up, clinical examination diagnosed slightly more patients with recurrent or de novo POP in the anterior and middle compartment (symptomatic cystocele or uterine prolapse) compared to dMRI (n = 9 vs. n = 8). However, dMRI diagnosed substantially more patients with recurrent or de novo POP in the posterior compartment (symptomatic enterocele or rectocele) compared to clinical examination (n = 17 vs. n = 4), including five patients with persistent POP at all examination time points. Three of them were evaluated as stage 0 by clinical examination, one was diagnosed as recurrent rectocele stage 2, and one was diagnosed as asymptomatic rectocele stage 1 (Fig. 3). Additionally, dMRI diagnosed three times more often recurrent multicompartment defects and slightly more one-compartment de novo POP as clinical examination did.

Fig. 3.

A 41-year-old woman presenting with S-POP stage 3 for bladder and cervix, S-POP stage 0 enterocele, and S-POP stage 2 rectocele, who underwent anterior mesh repair with concomitant vaginal hysterectomy and MiniArc single-incision sling system by American Medical Systems. At the 12-week follow-up, clinical examination showed S-POP stage 0 for all compartments. At the one-year and five-year follow-ups, clinical examination diagnosed a recurrent rectocele S-POP stage 2, while all other compartments showed no descent. On dMRI, a multicompartment defect was initially diagnosed with grade 3 for bladder and grade 2 for cervix, pouch and rectum (a). At the 12-week follow-up (b), bladder descent grade 1 and vaginal vault grade 0 were diagnosed (enterocele and rectocele: grade 2). At the one-year and five-year follow-ups (c, d), the bladder and vaginal vault were diagnosed with grade 0, while the enterocele increased to grade 3 at the five-year follow-up with a stable grade 2 rectocele. The patient’s QOL data support these results showing “general health perception” and “prolapse impact” mostly impaired before surgery, least impaired in the 12-week and one-year follow-ups, and recurrently impaired again in the five-year follow-up. B, bladder; C, cervix; P, pouch of Douglas; R, rectum; V, vaginal vault.

Regarding the results for POM measurements at the different time points, POM of the bladder showed the largest correction at 12 weeks postoperatively and stayed significantly improved at all examination time points, even if the mean value slightly increased again (Fig. 4). POM of the cervix/vaginal vault showed a similar trend; however, the mean value was statistically significant improved only at the 12-week follow-up. POM of the pouch of Douglas was reduced at the 12-week and one-year follow-ups, increasing again at the five-year follow-up, with an even worse result than preoperatively. On the contrary, POM of the rectum worsened at the 12-week follow-up and slightly improved at the one-year and five-year follow-ups (Fig. 4).

Fig. 4.

Development of pelvic organ mobility over time assessed with dMRI.

Symptom and QOL evaluation

Regarding the evaluation of the questionnaire for the presence of urinary symptoms, minor improvement was seen at the five-year follow-up with 18 of the initial 24 women stating they have remaining urinary symptoms. Regarding the evaluation of the questionnaire for the presence of defecation symptoms, no relevant changes were seen at the five-year follow-up with all 21 women stating they have remaining defecation problems. Six women assessed their remaining defecation problems as “being severe.” Of those, four were diagnosed with a de novo rectocele (75% by dMRI, 25% by clinical examination), one was diagnosed with a recurrent rectocele by dMRI, and one patient presented with only a stage/grade 1 rectocele. However, six of the eight QOL domains evaluated by P-QOL showed significant improvement (general health perception, prolapse impact, role limitations, physical limitations, social limitations, and emotions) (Table 3). Compared to the pre-surgical results, the scores are lowest (QOL increased) at 12 weeks after surgery and slightly increase up to 20–60% of the pre-surgical score results at the five-year follow-up (QOL decreased), while social limitations showed the most constant improvement over time (Table 3).

Table 3.

Pre- and post-surgical QOL results gathered with the German P-QOL questionnaire.*

	Pre surgery	12 weeks	1 year	5 years	P value
General health perception	58 ± 24.7	29.8 ± 15	29.7 ± 13.6	34.1 ± 14.5	<0.001
Prolapse impact	84.1 ± 19.4	20.1 ± 29.5	25 ± 28.6	36.4 ± 30.8	<0.001
Role limitations	70.1 ± 22.5	14.4 ± 26.1	23.3 ± 26.3	20.2 ± 23.9	<0.001
Physical limitations	71.8 ± 23.8	10.8 ± 23.4	14.9 ± 22.8	20.1 ± 25.2	<0.001
Social limitations	50.9 ± 30.8	7.9 ± 20.7	8.6 ± 17.2	8.2 ± 14.8	<0.001
Personal relationship	59.6 ± 36.1	15.4 ± 30	16.7 ± 19.2	35.5 ± 34.5	0.062
Emotions	35.3 ± 32	7.9 ± 24.1	13.2 ± 22.3	10.5 ± 18.7	0.006
Sleep/Energy	51.4 ± 28.8	25.4 ± 24.4	20 ± 23.3	38.1 ± 25.4	0.078

The eight quality-of-life life domains are presented as mean ± SD comparison using ANOVA; the lower the score, the better the QOL.

P-QOL questionnaire according to Lenz et al. and Digesu et al. [13,15].

Discussion

Clinical examination is the standard urogynecologic POP staging technique and enables the physician an unneglectable personal and haptic impression on patients’ pelvic organ behavior. However, dMRI has proven to be a useful addition where clinical examination has technical limits and may determine POP recurrence at an earlier date (12,14,16). By using the cine function, dMRI has the advantage of giving an objective visual impression of the interaction of the pelvic floor and the pelvic organs during straining without the influence of clinical examination tools and specula. It is more observer-independent due to the use of a standardized and predefined protocol and it also helps to gain knowledge of pelvic floor mechanisms and facilitates the diagnosis of complex disorders (9,14,16 –19).

We set out to assess postsurgical pelvic floor behavior in a medium-term follow-up of five years after vaginal mesh repair by applying dMRI in comparison to clinical examination and P-QOL questionnaire results. The following facts were observed over the course of this mid-term follow-up sample size study: (i) recurrent and de novo POP was diagnosed by clinical examination as well as by dMRI; (ii) dMRI results mostly differ to clinical examination results regarding the overall five-year outcome and the posterior compartment in particular; (iii) POM after five years aligns to preoperative status except for the bladder staying significantly improved; (iv) dMRI results best reflect the gathered QOL results regarding defecation disorders; (v) the examination triad of clinical examination, dMRI, and QOL questionnaire offers a holistic view of pelvic floor behavior.

In general, our study cohort is comparable to those of other studies in terms of BMI, age, and surgical data (5,20,21). For this analysis, the 12-week follow-up results served to monitor the anatomical cure rate of the reconstructive surgery performed. Focusing on the five-year follow-up, the total number of diagnosed recurrent or de novo cystoceles were comparable regarding clinical examination and dMRI results. However, dMRI diagnosed four times more often recurrent or de novo POP in the posterior compartment compared to clinical examination. In particular, five patients presented with persistent POP over the time on dMRI, being undetected in four patients and diagnosed as recurrent rectocele in one patient by clinical examination. In our study cohort, anterior mesh repair was mostly performed and we observed that the untreated posterior compartment had more hiatal space to descend during post-surgical straining. Regarding dMRI evaluation, POM pointed this out clearer than POP grade did. However, this did not generally result in clinical POP diagnosis at the time of evaluation.

The QOL outcome evaluated with the P-QOL questionnaire also worsened post surgery and thereby underlines the impression gathered by clinical examination and dMRI of accumulated recurrent or de novo POP occurring at the five-year follow-up. However, the subjective impression of the therapeutic outcome remains considerably improved for the treated woman herself at the five-year follow-up compared to pre-surgical results. This led to the presumption that the POP stage gained clinically or the metric measurements gained by imaging tools might best not be solely used to evaluate the outcome after vaginal mesh repair but to include the QOL evaluation in clinical routine to get a comprehensive impression of the individual pelvic floor disorder (1,15,22). Additionally, POM should be evaluated if dMRI is performed, as these results reflected best the gathered QOL results regarding defecation disorders in our study cohort.

Physicians might be encouraged to apply all three diagnostic modalities in their clinical routine, if possible, to gain a holistic view on pelvic floor behavior pre surgery and after vaginal mesh repair. In the pre-surgical setting, studies could show that dMRI led to changes of the surgical therapy plan in 61% of patients with POP and in 67% in patients with symptomatic posterior compartment defect in particular (23,24). Focusing on the posterior compartment, the differentiation between a rectocele or an enterocele or the clear identification of the content of a large enterocele can be challenging during clinical examination alone, but easily done by dMRI. If an enterocele is not recognized in pre-surgical therapy planning, this might have a direct consequence in the therapeutic outcome, e.g. persistent impairment of QOL or re-surgery (25 –27). In the post-surgical setting, the examination triad helps to identify those suffering from ongoing pelvic floor disorders. It has the potential to raise awareness of persistent, recurrent, or de novo disorders of the primarily asymptomatic and initially untreated compartment. Additionally, the treated compartment can be followed up and compared to the subjective patients’ impression in order to detect recurrent or persistent POP. Early detection of recurrent or de novo POP before being finally symptomatic might help educate women on the potential future behavior of their pelvic organs. Furthermore, it provides the physician the ability to focus on appropriate therapeutic options (e.g. risk factor reduction, more intensive pelvic floor muscle training) going forward.

Our study has some limitations. We are aware that a substantial number of patients of the pre-surgical study cohort (80%) was lost to follow-up for age-related or personal reasons over the five-year period, which resulted in a higher drop-out rate than Maher et al. gathered in a Cochrane Systematic Review with rates up to 53% (28). However, longitudinal mid-term follow-up studies after vaginal mesh repair are scarce and we could at least analyze 55% of the eligible five-year patients of our cohort. Due to the small sample size, no statistical subgroup analysis was performed for the different meshes used. Pelvic floor US was not part of the initial study design and was therefore not available for analysis. Besides the advantages of functional cross-sectional imaging of the pelvic floor, dMRI is more time-consuming and costly compared to other evaluation methods such as clinical examination or US limiting a widespread clinical application. However, the additional costs may individually be taken into consideration, e.g. in cases of complex pelvic floor disorders including posterior compartment defects or in symptomatic cases with influence on QOL without clear clinical findings.

In conclusion, an overall good anatomical outcome and patient satisfaction with a tendency for recurrent or de novo POP was seen in all three diagnostic modalities applied. Yet, if interpreted alone, clinical examination, dMRI, and QOL evaluation might mislead the observer in evaluating the therapeutic outcome. The combination of the three mentioned evaluation tools, however, enables a holistic view on the pelvic floor behavior after vaginal mesh repair. Focusing on dMRI, it objectively visualizes the interaction of the pelvic organs and the pelvic floor after reconstructive surgery. In particular, the evaluation of POM seems to correlate best with women’s personal impression on pelvic floor complaints.

Footnotes

Declaration of Conflicting Interests

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: KAB and FL received speaking honoraria by the company Serag Wiessner GmbH & Co. KG (Naila, Germany); FL received speaking honoraria by American Medical Systems, USA, and C. R. BARD GmbH, Karlsruhe, Germany. No money of speaking honoraria was used to fund this trial. KAB received research funding by Serag Wiessner GmbH & Co. KG (Naila, Germany) in the past, of which no money was used to perform this trial.

Funding

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

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