Effectiveness of botulinum toxin injection in the treatment of de novo OAB symptoms following midurethral sling surgery

Introduction and hypothesis

Intravesical onabotulinumtoxinA (Botox®) is effective for idiopathic overactive bladder (OAB) symptoms. Our primary objective was to compare the efficacy of onabotulinumtoxinA for women with de novo OAB after midurethral sling (MUS) surgery and women with idiopathic OAB.

Methods

Women enrolled in this prospective study had idiopathic (n?=?53) or de novo (n?=?49) OAB symptoms after MUS, with at least one episode of urgency urine incontinence per day. OnabotulinumtoxinA (100 U) was administered in 20 intradetrusor injections. Postvoid residual volumes were checked at 2, 4 and 12 weeks. Participants completed a 3-day bladder diary and the King’s Health Questionnaire (KHQ) before and 12 weeks after treatment.

Results

After 12 weeks, 22 patients (41.5 %) in the idiopathic OAB and 19 patients (38.8 %) in the de novo OAB groups were completely dry. OnabotulinumtoxinA injections had a significant benefit within both groups (p <0.001) to decrease both the daily numbers of voids (?2.39 and ?2.0) and incontinence episodes (?1.38 and ?1.44), with no significant difference between groups. We observed an increase of mean voided volume of >90 ml in both groups. Urinary retention was observed in four patients.

Conclusions

We observed similar improvement in OAB symptoms after intravesical onabotulinumtoxinA injections within both groups. The rates of retention and requirement for catheterization even for women with a prior MUS were acceptable. These observational data provide evidence that onabotulinumtoxinA can effectively treat patients with OAB following stress urinary incontinence surgery.

     

Evaluation of the local carcinogenic potential of mesh used in the treatment of female stress urinary incontinence

Introduction and hypothesis

To evaluate the carcinogenic potential of implanted synthetic mesh midurethral slings in the treatment of female stress urinary incontinence.

Methods

We identified female patients undergoing implantation of mesh materials for stress urinary incontinence at our institution from 1 January 2002 to 31 December 2012. This was accomplished by querying the medical records for CPT code 57288 (“sling operation for stress incontinence”) and a subsequent chart review to identify patients who underwent synthetic mesh sling placement. Medical records were then evaluated for the documentation of bladder, urethral, vaginal, cervical, uterine or ovarian cancers via the International Classification of Disease (ninth edition) coding. A chart review of patients with a cancer diagnosis was performed for verification of the diagnosis and evaluation of the temporal relationship with sling placement.

Results

During the study period, 2,474 patients underwent polypropylene midurethral sling placement. The median age was 57 years (IQR 47, 69) and the median follow-up was 60 months (IQR 23.3, 94.9). Overall, 51 patients also had a cancer diagnosis (8 bladder cancers, 7 vaginal malignancies, 8 ovarian carcinomas, 26 endometrial cancers, 2 cervical malignancies); however, only 2 cancers (0.08 %, 2 out of 2,474) developed following sling placement (a vaginal melanoma 3 years after sling placement and an ovarian tumor 1 year after sling placement). No cases of sarcoma formation, bladder, urethral or squamous cell carcinomas were identified.

Conclusions

With a median follow-up of 5 years after synthetic midurethral sling placement, development of pelvic malignancy was rare (0.08 %) and unlikely to be secondary to foreign body reaction from the implanted material.

     

Dynamic assessment of sling function on transperineal ultrasound: does it correlate with outcomes 1 year following surgery?

Introduction and hypothesis

To correlate dynamic assessment of sling function using 2D and 3D transperineal ultrasound with outcomes following transobturator sling surgery.

Methods

This is an unmatched case–control study of 100 patients who underwent transobturator sling surgery at our center between 2009 and 2012. Group A (n?=?50) patients had successful outcomes and group B (n?=?50) patients had suboptimal outcomes 1 year following surgery. The patients underwent 2D dynamic and 3D transperineal ultrasound. The two groups were compared with regard to the deformability of the sling on Valsalva, the concordance of urethral movement with the sling, and location of the sling.

Results

When compared with group B, group A had a significantly greater number of patients in whom the sling deformed at Valsalva (flat at rest, curving into a c-shape at Valsalva), the urethral movement was concordant with the sling and the sling had a midurethral location (p?<?0.0001). In all 17 patients in group B in whom the urethra moved in a concordant manner with the sling (34%), the sling did not deform on Valsalva maneuver and was located proximally. In all 15 patients in group A in whom the sling remained either flat or curved (30%), the urethra moved concordant with the sling and the sling was in midurethral location.

Conclusions

On 2D and 3D transperineal ultrasound, the best outcomes following transobturator sling surgery are associated with concordance of urethral movement with the sling, midurethral location, and deformability of the sling on dynamic assessment.

     

Carcinogenic potential of polypropylene mid-urethral slings: what do we know so far?

Introduction and hypothesis

Polypropylene (PP) mesh has come under increased scrutiny owing to previous FDA safety communications regarding the risks of mesh in trans-vaginal surgery and ensuing class action litigation for post-operative complications. Additional concerns have been raised regarding a possible link between implanted PP mesh and the long-term development of malignancy. Until recently, no research was specifically committed to the exploration of such a link. Our objective was to provide an overview of the recent literature focusing on any association between the use of PP mesh for midurethral sling procedures and the development of malignancy.

Methods

Multiple online research databases were searched for information related to any possible carcinogenic potential of PP mesh.

Results

There was no increased incidence in the development of malignancy after midurethral sling procedures using PP mesh in any of the studies.

Conclusion

Given the scarcity of evidence suggesting otherwise, the likelihood of PP mesh causing malignancy is exceptionally low. However, with few studies and an unknown latency period between exposure and diagnosis, more observational data would prove useful to exclude causality.

     

Predictors of voiding dysfunction following extensive vaginal pelvic reconstructive surgery

Introduction and Hypothesis

The objective of this study was to identify the predictors of postoperative voiding dysfunction in women following extensive vaginal pelvic reconstructive surgery.

Methods

We enrolled 1,425 women who had pelvic organ prolapse of POP-Q stage III or IV and had undergone vaginal pelvic reconstructive surgery with or without transvaginal mesh insertion from January 2006 to December 2014. All subjects were required to complete a 72-h voiding diary, and the IIQ-7, UDI-6, POPDI-6 and PISQ-12 questionnaires. Urodynamic study was performed preoperatively and postoperatively.

Results

Of the 1,425 women, 54 were excluded due to incomplete data, and 1,017 of the remaining 1,371 (74.2 %) had transvaginal mesh surgery and 247 (18 %) had concurrent midurethral sling insertion. Of 380 women (27.7 %) with preoperative voiding dysfunction, 37 (9.7 %) continued to have voiding dysfunction postoperatively. Of the remaining 991 women (72.3 %) with normal preoperative voiding function, 11 (1.1 %) developed de novo voiding dysfunction postoperatively. The overall incidence of postoperative voiding dysfunction was 3.5 % (48/1,371). Those with concurrent midurethral sling insertion were at higher risk of developing voiding dysfunction postoperatively (OR 3.12, 95 % CI 1.79?–?5.46, p?<?0.001). Diabetes mellitus, preoperative detrusor pressure at maximal flow (Dmax) <10 cm H₂O and postvoid residual volume ≥200 ml were significant risk factors for the development of postoperative voiding dysfunction (OR 3.07, 1.84 and 2.15, respectively; 95 % CI 1.69?–?5.60, 1.39?–?2.91 and 1.10?–?3.21, respectively).

Conclusions

Diabetes mellitus, concurrent midurethral sling insertion, preoperative Dmax <10 cm H₂O and postvoid residual volume ≥200 ml in patients with advanced pelvic organ prolapse were risk factors for the development of postoperative voiding dysfunction after vaginal pelvic reconstructive surgery. Therefore, counseling is worthwhile before considering vaginal pelvic reconstructive surgery.

     

Indications and risk factors for midurethral sling revision

Introduction and hypothesis

To determine the indications and risk factors for needing midurethral sling revision in a cohort of women undergoing midurethral sling placement.

Methods

This was a case–control study of all women undergoing midurethral sling placement for stress urinary incontinence (SUI) between January 2003 and December 2013. Cases were patients who underwent midurethral sling placement followed by sling revision (incision, partial or complete excision). Controls were patients who underwent sling placement only. Once all subjects had been identified, the electronic medical record was queried for demographic and perioperative and postoperative data.

Results

Of 3,307 women who underwent sling placement, 89 (2.7 %, 95 % CI 1.9 – 3.4) underwent sling revision for one or more of the following indications: urinary retention (43.8 %), voiding dysfunction (42.7 %), recurrent urinary tract infection (20.2 %), mesh erosion (21.3 %), vaginal pain/dyspareunia (7.9 %), and groin pain (3.4 %). The median time from the index to the revision surgery was 7.8 months (2.3 – 17.9 months), but was significantly shorter in patients with urinary retention. The type of sling placed (retropubic or transobturator) was not associated with indication for revision. Patients who underwent revision surgery were more likely to have had previous SUI surgery (adjusted odds ratio 4.4, 95 % CI 1.7 – 6.5) and to have undergone concomitant vaginal apical suspension (adjusted odds ratio 2.4, 95 % CI 1.4 – 4.5).

Conclusions

The rate of sling revision after midurethral sling placement was 2.7 %. Urinary retention and voiding dysfunction were the most common indications. Patients with a history of previous SUI surgery and concomitant apical suspension at the time of sling placement may be at higher risk of requiring revision surgery.

     

Predictors of vaginal mesh exposure after midurethral sling placement: a case–control study

Introduction and hypothesis

Female stress urinary incontinence is highly prevalent, and synthetic midurethral sling placement is the most common type of anti-incontinence surgery performed in the USA. We aimed to identify risk factors associated with surgery used to treated vaginal mesh exposure after midurethral sling placement for stress urinary incontinence.

Methods

We identified women who underwent anti-incontinence procedures from January 2002 through December 2012. Patients with vaginal mesh exposure undergoing surgical repair after midurethral sling placement were compared with a control group without mesh exposure in a 1:3 ratio. Patients with ObTape sling placement (Mentor Corporation) were excluded. Logistic regression models were used to evaluate associations between clinical risk factors and vaginal mesh exposure.

Results

Overall, 2,123 patients underwent primary sling placement, with 27 (1.3 %) having vaginal mesh exposure necessitating surgical repair. Patients with mesh exposure were more likely to have undergone previous bariatric surgery (P?=?0.008), hemoglobin <13 g/dL (P?=?0.006), premenopausal status (P?=?0.008), age <50 years (P?=?0.001), and the retropubic approach to sling placement (P?=?0.03). Multivariate analysis identified these risk factors: previous bariatric surgery (odds ratio [OR], 7.0; 95 % CI, 1.1–61.4), retropubic approach (OR, 5.7; 95 % CI, 1.1–107.0), preoperative hemoglobin <13 g/dL (OR, 2.8; 95 % CI, 1.1–7.5), and premenopausal status (OR, 2.6; 95 % CI, 1.0–7.3). Among postmenopausal patients, those with mesh exposure were significantly more likely to receive preoperative estrogen therapy (OR, 12.4; 95 % CI, 2.7–57.8).

Conclusions

Previous bariatric surgery, retropubic approach, premenopausal status, and lower preoperative hemoglobin were associated with a significantly increased risk of surgery for vaginal mesh exposure after midurethral sling placement. Recognizing these factors can improve preoperative patient counseling.

     

Concurrent midurethral sling excision or lysis at the time of repeat sling for treatment of recurrent or persistent stress urinary incontinence

Introduction and hypothesis

Limited evidence guides operative technique in primary midurethral sling (MUS) lysis or excision at the time of repeat sling placement for persistent or recurrent stress urinary incontinence (SUI). Our objective is to compare subjective improvement in patients undergoing repeat MUS placement with and without concurrent primary sling lysis or removal.

Methods

This was a retrospective cohort study with a prospective survey of patients who underwent two MUS placements for SUI at a single institution from January 1996 to December 2015. After patient identification, the electronic record was queried for demographic and perioperative data. Subjects then completed the Urogenital Distress Index, (UDI-6), Incontinence Severity Index (ISI), and the Incontinence Impact Questionnaire (IIQ-7). Subjects were also asked if they would choose to undergo repeat MUS surgery again.

Results

Sixty-one patients were included. 17 out of 61 (28%) underwent concomitant primary sling lysis or excision, and 44 out of 61 (72%) did not. Fifty-seven percent (n = 35) completed the survey. Of the respondents, the median ISI score was 4 (1–8), with no difference between groups; 14 out of 35 (40%) reported the presence of bothersome urge incontinence, 11 out of 35 (31%) reported bothersome stress urinary incontinence, and 8 out of 35 (23%) reported symptoms of voiding dysfunction, with no difference between groups. 57% of patients (20 out of 35) would undergo repeat MUS placement again.

Conclusions

In a small cohort, concurrent excision of the primary sling at the time of repeat MUS did not improve subjective outcomes. Many patients reported urinary urgency and voiding symptoms, and only about half of patients would choose to undergo the surgery again if given the choice.

     

Prevalence and predictors of overactive bladder in nonpregnant nulliparous women below 65 years of age

Introduction and hypothesis

The aetiology of the overactive bladder (OAB) symptom complex is still poorly understood. In order to obtain further insight, the prevalence and predictors of the symptoms included in OAB, that is urgency, urgency incontinence (UUI), frequency and nocturia, were investigated in a sample of nonpregnant nulliparous women.

Methods

A national, postal and web-based survey of OAB symptoms was conducted in women aged 25–64 years (n = 9,197). Crude prevalence and prevalence adjusted according to body mass index (BMI) were calculated from a logistic regression model to evaluate the prevalence of OAB.

Results

The response rate was 52%. The prevalence of urgency, bothersome urgency, UUI, and nocturia, but not daytime frequency, increased consistently with advancing age and increasing BMI. Urgency was associated with BMI, age ≥45 years, nocturia, and daytime frequency of eight or more micturitions. Daytime urinary micturition frequency was not affected by age either in women with OAB or in women without OAB. Bothersome OAB affected almost half of the woman in the oldest age group and was strongly associated with nocturia of two or more micturitions and OAB with UUI.

Conclusions

There were contrasting changes in the prevalence of the different symptoms included in OAB. With increasing age and BMI, the prevalence of nocturia, urgency and UUI increased, while daytime frequency remained stable. These findings are of importance as the primary endpoint for the evaluation of drug therapies for OAB has often been daytime urinary frequency.

     

Road to recovery after transvaginal surgery for urethral mesh perforation: evaluation of outcomes and subsequent procedures

Introduction and hypothesis

Urethral injury resulting from transvaginal mesh slings is a rare complication with an estimated incidence of <1%. Our objective was to review the surgical management and functional outcomes of women presenting with urethral mesh perforation following midurethral sling (MUS) placement.

Methods

This was a retrospective multicenter review of women who from January 2011 to March 2016 at two institutions underwent mesh sling excision for urethral perforation with Female Pelvic Medicine and Reconstructive Surgery fellowship-trained surgeons. Data comprising preoperative symptoms, operative details, and postoperative outcomes were collected by telephone (n?13) or based on their last follow-up appointment.

Results obtained

Nineteen women underwent transvaginal sling excision for urethral mesh perforation. Eight (42%) patients had undergone previous sling revision surgery. Sixty percent of women had resolution of their pelvic pain postoperatively. At follow-up, 92% reported urinary incontinence (UI), and three had undergone five additional procedures for vaginal prolapse mesh exposure (n?1), incontinence (onabotulinum toxin injection n?1, rectus fascia autologous sling n?1), prolapse (colpopexy n?1), and pain (trigger-point injection n?1). Patient global impression of improvement data was available for 13 patients, of whom seven (54%) rated their postoperative condition as Very much better or Much better.

Conclusions

The management of urethral mesh perforation is complex. Most women reported resolution of their pelvic pain and a high rate of satisfaction with their postoperative condition despite high rates of incontinence.

     

The value of synchro-cystourethrometry for evaluating the relationship between urethral instability and overactive bladder

Purpose

To investigate the correlation between urethral instability (URI) and overactive bladder (OAB) in children.

Methods

We retrospectively investigated 126 children with OAB and 36 children without OAB using synchro-cystourethrometry. The prevalence of detrusor overactivity (DO) and URI, and the diagnostic sensitivity of DO alone and DO combined with URI, was compared. The OAB children with URI voluntarily received transcutaneous electrical pudendal nerve stimulation with anisodamine (stimulation group, SG) or anisodamine alone (non-stimulation group, NSG). The effectiveness of treatment was evaluated. Average voided volume (AVV), maximum voided volume (MVV), and number of voids per day (NV) were collected and analyzed.

Results

In OAB children, the prevalence of DO and URI was 51.6 and 32.5%, respectively. The prevalence of URI was 5.6% in controls. The prevalence of URI was significantly higher in OAB children. The diagnostic sensitivity and Youden index of DO combined with URI were higher than DO alone. In SG, 45.7% of children were cured, with a ≥ 50% improvement rate of 82.9%, while no child was cured, with a ≥ 50% improvement rate of 36.8% in NSG. A significant increase in AVV and MVV together, with a decrease in NV, was seen in SG. There was a significant difference in visual analogue scale values between SG and NSG (P < 0.01).

Conclusions

Urethral instability plays an essential role in the pathogenesis and progression of OAB in children. Synchro-cystourethrometry is a useful urodynamic technology to precisely diagnose OAB, and transcutaneous electrical pudendal nerve stimulation may be an effective treatment for OAB children induced by URI.

     

Prospective and randomized clinical trial comparing transobturator versus retropubic sling in terms of efficacy and safety

Introduction and hypothesis

The midurethral sling is the most commonly performed surgical procedure for stress urinary incontinence (SUI). We compared the efficacy of transobturator tape (TOT) and retropubic (RP) slings by evaluating objective and subjective cure rates at 12 months postsurgery and evaluate the impact on quality of life (QoL) and record intra- and postoperative complications.

Methods

This was a randomized, controlled, prospective, clinical trial with analysis of noninferiority. The hypothesis was that the TOT sling is not inferior to the RP sling. A total of 92 women with SUI were selected and randomized into two groups: TOT and RP slings.

Results

Eighty-one patients maintained follow-up 12 months postoperatively. In the per-protocol analysis, the objective cure rates were 100% for the RP sling and 93% for the TOT sling (p = 0.029). The subjective cure rates were 92% for the RP sling and 90% for the TOT sling (p = 0.02). Because none of the upper limits of the confidence interval (CI) were above the noninferiority margin, noninferiority of the TOT sling could be concluded. In contrast, the intention-to-treat analysis could not show that the TOT sling was not inferior to the RP sling, because the upper limit of the CI surpassed the noninferiority margin. Postoperative complications were similar for both groups, except for higher urinary retention rates in the RP group. Regarding QoL, there was a significant improvement.

Conclusions

The cure rates of the per-protocol analysis showed the noninferiority of the TOT relative to the RP sling. The RP sling group exhibited higher urinary retention. Quality of life improved significantly in both groups.

     

De novo stress urinary incontinence after pelvic organ prolapse surgery in women without occult incontinence

Introduction and hypothesis

There is a paucity of data evaluating the risk of de novo stress urinary incontinence (SUI) after surgery for pelvic organ prolapse (POP) in women with no preoperative occult SUI. We hypothesized that apical suspension procedures would have higher rates of de novo SUI.

Methods

This was a retrospective database review of women who had surgery for POP from 2003 to 2013 and developed de novo SUI at ≥6 months postoperatively. Preoperatively, all patients had a negative stress test and no evidence of occult SUI on prolapse reduction urodynamics. The primary objective was to establish the incidence of de novo SUI in women with no objective evidence of preoperative occult SUI after POP surgeries at ≥6 months.

Results

A total number of 274 patients underwent POP surgery. The overall incidence of de novo SUI was 9.9 % [95 % confidence interval (CI) 0.07–0.14]. However, the incidence of de novo SUI in those with no baseline complaint of SUI was 4.4 % (95 % CI 0.03–0.1). There was no difference in de novo SUI rates between apical [9.7 % (n?=?57)] and nonapical [10.5 %, (n?=?217] procedures (p?=?0.8482). Multivariate logistic regression identified sacrocolpopexy [adjusted odds ratio (OR) 4.54, 95 % CI 1.2–14.7] and those with a baseline complaint of SUI (adjusted OR 5.1; 95 % CI 2.2–12) as risk factors for de novo SUI.

Conclusions

The incidence of de novo SUI after surgery for POP without occult SUI was 9.9 %. We recommend counseling patients about the risk of de novo SUI and offering a staged procedure.

     

Multicentre randomized trial of the Ajust™ single-incision sling compared to the Align™ transobturator tape sling

Introduction and hypothesis

Tension-free suburethral tapes have become the first-line surgical treatment for female stress urinary incontinence. Single-incision midurethral slings (SIMS) were introduced with the aim of offering similar efficacy with reduced morbidity, particularly postoperative pain. The objective of this study was to compare the effectiveness and complications of the Ajust? SIMS and the Align? transobturator tape sling.

Methods

We performed a randomized controlled trial with a noninferiority design. Women with pure stress urinary incontinence or stress-predominant mixed urinary incontinence were eligible. The primary outcome was the cure/improvement rate at 1 year, defined according to combined objective and subjective criteria. Rate differences for cure/improvement with the two procedures were calculated along with their 95% confidence intervals. The Sandvik incontinence severity index and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) were completed before surgery and at 1 year. Complications were also reported.

Results

We randomized 30 women to the Ajust? group and 28 to the Align? group. At 1 year the cure/improvement rates were 93.3% in the Ajust? group and 96.4% in the Align? group. The rate difference for cure/improvement was of ?3.1% (95% CI ?14.4 % to 8.2%). The study was sufficiently powered to conclude the noninferiority of Ajust? SIMS under the pre-established criteria. Three women in the Ajust? group reported persistent thigh pain 1 year after surgery, but none in the Align? group reported pain.

Conclusions

At 1 year, the Ajust? SIMS showed non-inferior effectiveness compared with the Align? transobturator sling. Although not statistically significant, unexpectedly, more women reported persistent thigh pain in the Ajust? group.

     

Outcome of coexistent overactive bladder symptoms in women with urodynamic urinary incontinence following anti-incontinence surgery

Introduction and hypothesis

The objective was to investigate the outcome of stress urinary incontinence (SUI) and overactive bladder (OAB) symptoms in women with urodynamic stress incontinence (USI) after transobturator sling procedures (TOTs).

Methods

We evaluated 109 consecutive patients with USI, who had undergone TOT in a tertiary hospital between 2012 and 2014. All patients received evaluations, including structured urogynecological questionnaires and pelvic organ prolapse quantification examination before, and 3 and 12 months after surgery. One-hour pad test and urodynamic testing were performed before and 3–6 months postoperatively. Patient demographics, lower urinary tract symptoms, and urodynamic results were analyzed between pure USI and USI with OAB symptoms.

Results

Persistent SUI occurred in 8 patients at 3 months (7.3 %) and 7 patients at 12 months (6.4 %) postoperatively. The most common OAB symptom was frequency (54.1 %), followed by urgency urinary incontinence (52.3 %), urinary urgency (42.2 %), and nocturia (33 %). Most of these OAB symptoms were resolved at the 3-month and 12-month follow-ups both in patients treated with TOT only and in those treated with TOT combined with other pelvic surgeries. There was no significant difference in the preoperative urodynamic changes between patients with pure USI and USI without OAB groups. However, postoperative urodynamic results showed a significant decrease in the maximal urethral closure pressure in the group of patients with USI and OAB symptoms, but no significant urodynamic changes in the group with pure USI.

Conclusions

Coexistent OAB symptoms are common in women who were diagnosed with USI and most of these symptoms may resolve 3 and 12 months after TOT.

     

A randomised comparison of single-incision versus traditional transobturator midurethral sling in women with stress urinary incontinence: results of a 24-month follow-up

Introduction and hypothesis

Midurethral sling procedures have become the principal surgical treatment for women with stress urinary incontinence (SUI). The 1-year results of this international trial comparing the efficacy and morbidity of a single-incision midurethral sling (SIMS; MiniArc) and a transobturator standard midurethral sling (SMUS; Monarc) showed that MiniArc is non-inferior regarding subjective cure and superior with regard to postoperative pain and recovery. The objective was to compare subjective and objective cure, morbidity and surgery-related discomfort following SIMS and transobturator SMUS up to a 24-month follow-up.

Methods

We carried out a non-blinded, randomised, controlled trial. Women with symptomatic SUI were eligible. Primary outcome was subjective cure, defined as an improvement on the Patient Global Impression of Improvement (PGI-I), at 12, 24 and 36 months. Secondary outcomes were objective cure based on the cough stress test, disease-specific quality of life questionnaires, surgical parameters and physical performance during recovery. Analysis was by intent to treat. Differences between the two groups regarding dichotomous variables were Chi-squared tested and presented as relative risks (RR) with corresponding 95 % confidence intervals.

Results

We randomised 97 women to MiniArc and 96 to Monarc. At the 24-month follow-up, subjective cure was 84 % following MiniArc and 89 % following Monarc (RR ?5; 95% CI ?0.17 to 0.06). Objective cure was 93 % following MiniArc and 94 % following Monarc (RR ?1; 95% CI ?0.10 to 0.07). Both procedures have low complication rates.

Conclusions

At the 2-year follow-up, the non-prespecified analysis of this randomised trial showed that the MiniArc, a single-incision sling, had similar subjective and similar objective cure rates, although non-inferiority to Monarc for subjective cure could not be demonstrated.

     

Long-term efficacy and safety of tension free vaginal tape in a historic cohort of 463 women with stress urinary incontinence

Introduction and hypothesis

We report retrospective data on the long-term safety and efficacy of the retropubic midurethral sling (MUS) in a large series of women with stress urinary incontinence.

Methods

In all, 517 patients were treated during the period January 2005 to June 2012 at a single centre in France. The Urinary Symptoms Profile score was used to identify women who were subjectively cured or improved or in whom treatment had failed. The rates of peroperative, and early (<30 days) and late postoperative complications were recorded.

Results

A total of 463 patients were evaluable at a mean (±SD) follow-up of 71?±?23 months. At the last follow-up, 344 patients (74.3 %) demonstrated subjective cure, 55 (11.9 %) were improved and 64 (13.8 %) had treatment failure. Bladder perforations occurred in 33 patients (7.1 %); however, this had no effect on cure rate. In the early postoperative period, temporary intermittent self-catheterization was required in 10 patients (2.2 %) due to voiding difficulties. The most frequent long-term postoperative complication was de novo urge incontinence that was reported by 59 patients (12.7 %); seven patients (1.5 %) needed tape excision due to voiding difficulties and six (1.3 %) needed tape removal due to erosion or chronic pain.

Conclusions

The retropubic MUS was shown to be durable at a mean follow-up of 71?±?23 months, with a high success/improvement rate and no serious long-term tape-induced adverse effects.

     

Methodology for a vaginal and urinary microbiome study in women with mixed urinary incontinence

Introduction and hypothesis

We describe the rationale and methods of a study designed to compare vaginal and urinary microbiomes in women with mixed urinary incontinence (MUI) and similarly aged, asymptomatic controls.

Methods

This paper delineates the methodology of a supplementary microbiome study nested in an ongoing randomized controlled trial comparing a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone for MUI. Women in the parent study had at least “moderate bother” from urgency and stress urinary incontinence symptoms (SUI) on validated questionnaire and confirmed MUI on bladder diary. Controls had no incontinence symptoms. All participants underwent vaginal and urine collection for DNA analysis and conventional urine culture. Standardized protocols were designed, and a central lab received samples for subsequent polymerase chain reaction (PCR) amplification and sequencing of the bacterial16S ribosomal RNA (rRNA) gene. The composition of bacterial communities will be determined by dual amplicon sequencing of variable regions 1–3 and 4–6 from vaginal and urine specimens to compare the microbiome of patients with controls. Sample-size estimates determined that 126 MUI and 84 control participants were sufficient to detect a 20 % difference in predominant urinary genera, with 80 % power and 0.05 significance level.

Results

Specimen collection commenced January 2015 and finished April 2016. DNA was extracted and stored for subsequent evaluation.

Conclusions

Methods papers sharing information regarding development of genitourinary microbiome studies, particularly with control populations, are few. We describe the rigorous methodology developed for a novel urogenital microbiome study in women with MUI.