Background: We evaluated the effect of transvaginal mesh (TVM) surgery for voiding function and continence using noninvasive examination and questionnaire. The present study aimed to ascertain which categories of patients need concomitant mid-urethral sling (MUS) after TVM surgery. Methods: We included women who underwent TVM procedure between November 2009 and October 2013. Data from noninstrumented uroflowmetry and questionnaires about urinary symptoms were analyzed. Results: The present study investigated the cases of 961 women who underwent TVM surgery. The persistence of stress urinary incontinence (SUI) was 57.6%. Almost all the parameters measured using uroflowmetry and questionnaires significantly improved in all types of urinary incontinence 12 months after surgery. A history of hysterectomy, preoperative high flow (corrected maximum flow rate > 1.5), and preoperative urge urinary incontinence were independent risk factors for the persistence of SUI. Conclusions: TVM for pelvic organ prolapse improved subjective and objective voiding function. Mixed urinary incontinence (MUI) patients with high urinary flow may be suitable for concomitant MUS with TVM because of the high level of SUI persistence.
Keywords: Pelvic organ prolapse; Stress urinary incontinence; Transvaginal mesh; Mid-urethral sling; Voiding function
Pelvic organ prolapse (POP) is frequent, with a prevalence that ranges from 2.9 to 11.4% when assessed by questionnaire and from 31.8 to 97.7% when evaluated by clinical examination [[
The symptoms of voiding dysfunction and overactive bladder associated with POP are usually mitigated by POP repair (surgery or ring pessary) [[
In women with POP and coexisting SUI, concomitant mid-urethral sling (MUS) with POP surgery results in a high cure rate of SUI at 1-year follow-up (success rate 95%) [[
In addition, voiding dysfunction following anti-incontinence surgery is not uncommon. Although MUS produces a dynamic urethral kinking without compressing the urethra at rest, 4–43% of patients develop obstructive voiding symptoms. Han et al. showed that maximum flow rate is significantly reduced at long-term follow-up after MUS [[
In this study, we evaluated the effect of TVM surgery on voiding function and continence using noninvasive examination and questionnaire. In addition, we considered which categories of patients need concomitant MUS with TVM surgery.
The study population comprised women who underwent TVM surgery for POP at the urogynecology center of Senboku-Fujii Hospital between November 2009 and October 2013. The surgical procedure using soft polypropylene mesh was based on that reported by the French TVM group (Gynemesh PS™) [[
Measurements were performed before surgery and at 12 months follow-up. Physical examination including POP-Q was performed. Noninstrumented uroflowmetry and measurement of post-voided residual urine was performed using ultrasonography. Patients were asked to void with a comfortably full bladder, in sitting position, into a gravimetric uroflowmeter. Based on the guideline [[
Data regarding Overactive Bladder Symptom Score (OABSS), International Prostate Symptom Score and QOL score (IPSS/QOL), and International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) were acquired from the questionnaires. Patients were categorized into groups according to their category of urinary incontinence (UI) (patients without UI: No UI Group; patients with pure SUI: SUI Group; patient with pure urge urinary incontinence: UUI Group; and patients with mixed urinary incontinence: MUI Group). UI was classified on the basis of self-diagnostic items of ICIQ-SF. SUI was diagnosed if the patient experienced urine leakage during coughing, sneezing, or physical activity; UUI was diagnosed if the patient experienced urine leakage before she could reach the toilet; and MUI was diagnosed if the patient had both SUI and UUI as Abdullah et al. previously reported [[
The primary outcome of this study was the persistence of SUI in patients with preoperative SUI. Further, this study measured the occurrence of de novo SUI and UUI, and the persistence of UUI. We compared SUI persistence in patients who had preoperative pure SUI with those who had preoperative MUI using the chi-square test. UUI persistence was similarly compared. Changes recorded by the uroflowmetry and questionnaire responses were evaluated. Comparisons of the uroflowmetric data and questionnaire replies before and 12 months after TVM surgery were performed using the Wilcoxon signed-rank test. Univariable logistic regression was used to identify risk factors for postoperative low urinary flow and SUI persistence. The considered risk factors were patient age, parity, body mass index (BMI), the presence of diabetes mellitus, the presence of cerebrovascular disease, previous hysterectomy, POP stage, cQmax, and preoperative UUI. Odds ratios (OR) and 95% confidence interval (CI) for postoperative low urinary flow and SUI persistence are presented. Multivariable logistic regression was performed to identify independence of variables. Variables with a P-value < 0.1 in the univariable analysis were included in multivariable analysis. In all analyses, p < 0.05 indicates statistical significance.
The present study investigated the cases of 961 women who underwent TVM surgery. Table 1 shows the characteristics of the women included in the study. Nineteen patients experienced intraoperative complications involving bladder perforation and 5 patients experienced more than 300 ml blood loss. Postoperative complication were graded using the Clavien–Dindo classification and the grade 2 complication rate was 6.9% (residual urine/ urinary retention [n = 60], hematoma [n = 5], pelvic abscess [n = 1]). No patients experienced greater than grade 2 complications.
Patient characteristics
Characteristic N = 961 Age (years) 68 (43–89) Parity (n) 2 (0–9) Body mass index (kg/m2) 23.5 (16.4–35.1) Postmenopausal states (yes) 939 (97.7%) Pelvic organ prolapse Stage 2 91 (9.5%) Stage 3 or 4 870 (90.5%) Surgical site Anterior compartment 930 (96.8%) Posterior compartment 519 (54.0%) Previous pelvic organ prolapse surgery 60 (6.2%) Previous hysterectomy 150 (15.6%) Diabetes mellitus 88 (9.2%) Cerebrovascular disease 38 (4.0%) Anatomical recurrence at 1-year (POP-Q > Stage 1) 16 (1.7%)
POP-Q pelvic organ prolapse quantification assessment
Eighteen patients (1.9%) underwent concomitant MUS, and 34 patients (3.5%) underwent postoperative MUS before 12 months follow-up. Changes in the incidence of incontinence before and after TVM surgery were evaluated; patients who underwent MUS after 12 months follow-up were excluded (Table 2). SUI persistence was 57.6% (258/448) and UUI persistence was 37.4% (134/358). De novo SUI rate was 36.6% (161/440) and de novo UUI rate was 8.3% (44/530). SUI persistence in preoperative MUI patients was 63.4% (121/191) and was significantly higher than that in preoperative pure SUI patients (53.3% 137/257 p = 0.033). There was no significant difference between the UUI persistence in preoperative MUI patients (40.3% 77/191) and that on preoperative pure UUI patients (34.1% 57/167 p = 0.228).
Changes in the types of incontinence before and after surgery
Preoperative No UI SUI UUI MUI N = 273 (%) N = 257 (%) N = 167 (%) N = 191 (%) Postoperative No UI 173 (63.4) 113(44.0) 64 (38.3) 43 (22.5) SUI 79 (28.9) 118 (45.9) 44 (26.3) 68 (35.6) UUI 10 (3.7) 5 (1.9) 29 (17.4) 24 (12.6) MUI 10 (3.7) 19 (7.4) 28 (16.8) 53 (27.7) Unclassified 1 (0.4) 2 (0.8) 2 (1.2) 3 (1.6)
No UI no urinary incontinence, SUI stress urinary incontinence, UUI urge urinary incontinence, MUI mixed urinary incontinence The number of patients with preoperative unclassified UI is 21
Table 3 shows the changes in uroflowmetric parameters and responses to questionnaires about urinary symptoms. All the parameters of uroflowmetry significantly improved in all types of UI 12 months after surgery. In questionnaires about urinary symptoms, the responses, apart from the ICIQ-SF score of patients without preoperative UI, showed significant improvement regardless of the types of UI 12 months after surgery.
Changes in uroflowmetry parameters and results of questionnaires on urinary symptoms before and 12 months after surgery
No UI SUI UUI MUI pre post p pre post p pre post p pre post p cQmax 1.16 ± 0.46 1.46 ± 0.61 0.000 1.22 ± 0.49 1.53 ± 0.58 0.000 1.11 ± 0.44 1.43 ± 0.59 0.000 1.21 ± 0.53 1.57 ± 0.68 0.000 cQave 0.61 ± 0.27 0.91 ± 0.37 0.000 0.64 ± 0.27 0.96 ± 0.38 0.000 0.55 ± 0.23 0.89 ± 0.36 0.000 0.63 ± 0.29 0.97 ± 0.40 0.000 PVR (mL) 18.0 ± 52.5 8.6 ± 29.5 0.015 17.5 ± 55.2 5.8 ± 25.8 0.002 38.4 ± 79.4 7.8 ± 26.1 0.000 19.1 ± 5.38 6.0 ± 25.6 0.002 OABSS 2.8 ± 2.2 2.3 ± 1.8 0.001 3.2 ± 2.7 2.7 ± 2.3 0.000 6.3 ± 3.1 4.1 ± 3.0 0.000 6.6 ± 3.4 4.1 ± 3.0 0.000 IPSS 8.0 ± 7.0 4.5 ± 4.8 0.000 9.0 ± 7.2 4.5 ± 4.7 0.000 11.5 ± 7.0 6.3 ± 9.0 0.000 13.1 ± 8.9 5.5 ± 5.1 0.000 ICIQ-SF 2.7 ± 2.9 2.6 ± 3.1 0.737 7.4 ± 3.3 4.5 ± 4.2 0.000 9.2 ± 3.8 4.9 ± 4.0 0.000 11.0 ± 4.5 5.9 ± 4.4 0.000 QOL score 3.9 ± 1.7 1.7 ± 1.3 0.000 4.5 ± 1.5 2.0 ± 1.5 0.000 5.1 ± 1.2 2.3 ± 1.6 0.000 5.3 ± 1.0 2.3 ± 1.6 0.000
cQmax Corrected maximum flow rate, cQave Corrected average flow rate, PVR Post-void residual urine, OABSS Overactive bladder symptom score, IPSS International prostate symptom score, ICIQ-SF International consultation on incontinence questionnaire – Short Form
Table 4 shows the OR for the risk of SUI persistence using univariable and multivariable logistic regression. This study identified a history of hysterectomy, preoperative high flow (cQmax > 1.5), and preoperative UUI as independent risk factors for SUI persistence (p < 0.05). Table 5 presents the univariable and multivariable analysis of postoperative low urinary flow (cQmax < 1.0). This study identified the presence of diabetes mellitus and preoperative low urinary flow (cQmax < 1.0) as independent risk factors for postoperative low urinary flow (p < 0.05).
Odds ratios for the risk of postoperative stress urinary incontinence using univariable and multivariable logistic regression
Factor Patients with preoperative SUI Univariable logistic regression Multivariable logistic regression p-value OR (95% CI) p-value OR (95% CI) Age (> 68 years old) 0.716 1.073 (0.734–1.570) Parity (> 3 times) 0.082 1.436 (0.956–2.159) 0.060 1.492 (0.983–2.264) BMI (> 24 kg/m2) 0.778 1.056 (0.722–1.545) Diabetes mellitus 0.320 1.426 (0.709–2.867) Cerebrovascular disease 0.924 0.958 (0.395–2.322) Hysterectomy history 0.065 1.704 (0.967–3.002) 0.046 1.802 (1.010–3.217) POP stage (> Stage 3) 0.276 1.436 (0.749–2.754) cQmax (> 1.5) 0.003 2.050 (1.274–3.299) 0.002 2.147 (1.325–3.480) UUI preoperatively 0.028 1.543 (1.047–2.272) 0.036 1.525 (1.027–2.269)
BMI Body mass index, POP Pelvic organ prolapse, cQmax Corrected maximum flow rate, UUI Urge urinary incontinence
Odds ratios for the risk of postoperative low urinary flow (cQmax < 1.0) using univariable and multivariable logistic regression
Factor Patients with preoperative SUI Univariable logistic regression Multivariable logistic regression p-value OR (95% CI) p-value OR (95% CI) Age (> 68 years old) 0.086 1.585 (0.937–2.682) 0.511 1.206 (0.690–2.107) Parity (> 3 times) 0.989 1.004 (0.576–1.749) BMI (> 24 kg/m2) 0.237 0.723 (0.423–1.237) Diabetes mellitus 0.001 3.444 (1.660–7.145) 0.004 3.112 (1.435–6.748) Cerebrovascular disease 0.481 0.587 (0.134–2.582) Hysterectomy history 0.356 1.385 (0.694–2.762) POP stage (> Stage 3) 0.164 0.569 (0.257–1.258) cQmax (< 1.0) 0.000 3.431 (1.989–5.918) 0.000 3.286 (1.885–5.728) UUI preoperatively 0.575 1.162 (0.687–1.967)
BMI Body mass index, POP Pelvic organ prolapse, cQmax Corrected maximum flow rate, UUI Urge urinary incontinence
Various surgical procedures for POP have been developed to date. Traditional colporrhaphy for POP using native tissue has a high anatomic failure rate of 58% [[
Previously, we have shown that women with untreated POP have impaired detrusor contractility and bladder outlet obstruction, which significantly improve after TVM surgery [[
The previous report showed that concomitant MUS with POP surgery reduced postoperative SUI in women with preoperative SUI [[
Some studies have used multichannel urodynamic testing to identify the predictors of postoperative UI. Our previous investigation showed that urethral obstruction was an independent predictor of de novo SUI [[
There were limitations to this retrospective study. Firstly, a considerable number of patients were excluded because of incomplete data. Exclusion of incomplete data meant there was a possibility that selection bias had been applied. Secondly, the classification of UI may not be accurate enough because we classified types of UI based on subjective data. However, the present study identified previous hysterectomy, preoperative high flow, and preoperative UUI as independent risk factors for SUI persistence. It is reported that surgical treatment of MUI with MUS results in cure or improvement of urinary urgency, frequency and UUI in 30–70%, SUI in approximately 80–90% patients [[
TVM for pelvic organ prolapse improved subjective and objective voiding function. This study showed that preoperative high flows, MUI, and a history of hysterectomy predicted persistent SUI. Patients with MUI and high urinary flow may be candidates for concomitant MUS with TVM because of the high incidence of SUI persistence.
SK: Project development, Data collection, Data analysis, Manuscript writing. KN: Data collection, Data analysis, Manuscript writing. SU: Data analysis. MT: Data collection, Data analysis. YK: Manuscript editing. AM: Project supervision. All authors read and approved the final manuscript.
The present study was approved by the Institutional Ethics Committee of the Senboku-Fujii Hospital. The research content is posted on outpatient of Senboku-Fujii Hospital and data of cases without opt-out intention were adopted. The data used in this study was anonymised before its use.
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The authors declare no conflict of interest associated with this manuscript. The authors would like to thank Enago (
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
The datasets during and/or analyzed during the current study are available from the corresponding author on reasonable request.
By Shohei Kawaguchi; Kazutaka Narimoto; Satoko Urata; Masami Takeyama; Yoshifumi Kadono and Atsushi Mizokami