A randomized,nonblinded extension study of single-incision versus transobturator midurethral sling in women with stress urinary incontinence

Introduction and hypothesis

Midurethral sling procedures are the first surgical option in women undergoing surgery for stress urinary incontinence (SUI). Single-incision midurethral-slings (SIMS) were designed to provide similar efficacy to traditional midurethral slings but with reduced morbidity. In this international trial we compared the efficacy of a SIMS (MiniArc) and a transobturator standard midurethral sling (SMUS; Monarc) in the treatment of SUI in terms of subjective and objective cure rates and morbidity over a long-term follow-up.

Methods

This was a randomized controlled nonblinded extended trial with a follow-up period of 36 months. Women with symptomatic SUI were eligible. The primary outcome was subjective cure, defined as an improvement in the Patient Global Impression of Improvement (PGI-I) score. Secondary outcomes were objective cure (negative cough stress test), disease-specific quality of life, surgical parameters and morbidity. An intention to treat analysis was performed. Differences in dichotomous variables were tested using the chi-squared test. Differences in continuous variables were tested using Student’s t test or the Mann-Whitney U test. We hypothesized that MiniArc would be noninferior to Monarc concerning subjective cure.

Results

We randomized 97 women to the MiniArc group and 96 to the Monarc group. The attrition rate was 23% in the MiniArc group and 22% in the Monarc group after 3 years. At 36 months, the subjective cure rates were 86% in the MiniArc group and 87% in the Monarc group (risk difference ?0.6%, 95% CI ?12 to 11%). The objective cure rates were 89% and 88%, respectively (risk difference 1.3%, 95% CI ?9 to 11%). Both procedures were associated with low complication rates.

Conclusions

After a follow-up of 36 months, MiniArc (SIMS) is non-inferior to Monarc (SMUS) with respect to subjective and objective cure.

     

A Randomized Comparison of a Single-incision Midurethral Sling and a Transobturator Midurethral Sling in Women with Stress Urinary Incontinence: Results of 12-mo Follow-up

Background

Midurethral sling procedures have become the prime surgical treatment for women with stress urinary incontinence (SUI). Single-incision mini-slings (SIMS) potentially offer similar efficacy with reduced morbidity. This international multicenter trial compared the efficacy and morbidity of a SIMS (MiniArc) and a transobturator standard midurethral sling (SMUS) (Monarc).

Objective

To compare subjective and objective cure, morbidity, and surgery-related discomfort following SIMS and transobturator SMUS.

Design, setting, and participants

Prospective randomized controlled trial with an initial follow-up period of 12 mo. Women with symptomatic SUI were eligible.

Outcome measurements and statistical analysis

Primary outcome was subjective cure, defined as an improvement on the Patient Global Impression of Improvement (PGI-I). Coprimary outcome was the mean visual analog scale (VAS) pain score (0–100) during 3 d after surgery. Secondary outcomes were objective cure based on the cough stress test (CST), disease-specific quality of life determined by the Urogenital Distress Inventory (UDI-6) score, surgical parameters, and physical performance during recovery. Analysis was by intent to treat. Differences between the MiniArc and Monarc groups on dichotomous variables were chi-square tested and presented as relative risks (RR) with corresponding 95% confidence intervals. We hypothesized that MiniArc was noninferior to Monarc concerning subjective cure and superior concerning postoperative pain.

Results and limitations

We randomized 97 women to MiniArc and 96 to Monarc. At 12-mo follow-up, subjective cure was 83% following MiniArc and 86% following Monarc (p = 0.46). Objective cure was 89% following MiniArc and 91% following Monarc (p = 0.65). The mean pain VAS score during the first three postoperative days was 9 following MiniArc and 22 following Monarc (Mann-Whitney U test, p < 0.01).

Conclusions

At 1-yr follow-up, MiniArc was noninferior to Monarc with respect to subjective and objective cure and superior with respect to postoperative pain.

Patient summary

This 1-yr randomized clinical trial showed that MiniArc, a single-incision midurethral sling, is noninferior to Monarc, a transobturator sling, with respect to cure and superior with respect to pain and recovery.     

Five-year follow-up study of Monarc transobturator tape for surgical treatment of primary stress urinary incontinence

Introduction and hypothesis

We hypothesized that transobturator tape (TOT) is safe and efficacious for the treatment of urodynamic stress incontinence in the long term.

Methods

We conducted a prospective study of patients with confirmed urodynamic stress incontinence (USI) who underwent a Monarc^TM TOT procedure in a tertiary center between February 2006 and March 2009 without other concurrent surgical procedures. Urodynamics were conducted at 1 and 3 years postoperatively. Subjective evaluation included Incontinence Impact Questionnaire (IIQ-7), Urinary Distress Inventory Questionnaire (UDI-6), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Objective cure was defined as no urinary leakage demonstrable on provocative filling cystometry and/ or 1-h pad test of <2 g. Subjective cure was based on a negative response to question 3 in UDI-6. Paired-samples t test, chi-square, and Fisher exact tests were applied; p?<?0.05 was considered significant. The log-rank tests were used to compare event-free survival.

Results

Sixty patients were enrolled, and 56 were evaluated at 5 years postoperatively. The majority were middle aged, postmenopausal, and overweight. Mean operating time was 31.1?±?8.9 min, intraoperative complications were minor, and median period of follow-up was 80.3?±?9.6 months. At 5 years of follow-up, objective and subjective cure rates were 89.3 % and 87.5 %, respectively. No mesh-related complications were seen. One patient needed a repeat midurethral sling procedure, and one patient each had bladder and bowel cancer.

Conclusion

Monarc TOT was safe and retained its high cure rate in the short- and long-term treatment of stress urinary incontinence.

     

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 overactive bladder following midurethral sling procedures: a systematic review of the literature and meta-analysis

Introduction and hypothesis

De novo overactive bladder (OAB) is a known complication of midurethral sling surgery for the treatment of stress urinary incontinence. To date, differences in the incidence of de novo OAB following the use of different types of midurethral sling remain relatively unknown. The purpose of the present systematic review was to evaluate this incidence and summarize current evidence.

Methods

We systematically searched the literature using the MEDLINE, Embase, Scopus, ClinicalTrials.gov, LILACS and Cochrane Central Register of Controlled Trials databases as well as the grey literature and references from the electronically retrieved articles. For comparisons of proportions, we used the chi-squared test. All reported analyses were designed as two-tailed. Statistical significance was set at p < 0.05.

Results

Finally, 32 studies were included in this systematic review, with a total of 3,139 patients who had undergone midurethral sling procedures that included transobturator tapes (TOT), retropubic tapes (TVT) or single-incision tapes (mini-slings). The overall incidence of de novo OAB was 11.5% in nonrandomized studies (280 women) and 6.4% in randomized studies (50 women). In relation to the type of midurethral sling, the incidence of de novo OAB was 9.7% for mini-slings, 11.2% for TVT-O, 8.7% for TOT and 9.8% for TVTs. The chi-squared test did not reveal significant differences (p = 0.58).

Conclusions

Current evidence suggests that the overall incidence of de novo OAB following midurethral sling procedures is approximately 9%. There is not enough evidence to support differences in the effects of the different types of sling with regard to this particular postoperative complication.

     

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.

     

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.

     

Transobturator versus single incision slings: 1-year results of a randomized controlled trial

Introduction and Hypothesis

To compare 1-year surgical outcomes following transobturator (TO) sling placement and single incision (SI) sling placement for the treatment of stress urinary incontinence (SUI).

Methods

We performed a randomized trial at a single institution. Patients with urodynamically proven SUI were offered participation and randomized to placement of a TO sling (Monarc?) or a SI sling (MiniArc?) between 2008 and 2011. The primary outcome measure was urinary leakage during standardized cough stress test (CST). Forty subjects in each group were required to achieve 80 % power to detect an effect size of 0.25.

Results

A total of 98 patients were randomized with 49 patients in the TO group and 49 patients in the SI group. Preoperative demographics were similar between the groups (Table 1). The TO group had a significantly longer sling operative time (10.7?±?4.8 min vs. 7.8?±?4.9 min, p?<?0.001) and greater estimated blood loss (31.6?±?26.6 mL vs. 22.9?±?22.1 mL, p?=?0.02). At the 1-year follow-up, there was no difference in the primary outcome with 9 TO patients (21 %) and 12 SI patients (29 %) having a positive CST (p?=?0.5). A composite measurement of ‘failure’, defined as patient-reported SUI and a positive CST, showed no difference between the TO group (17 %) and the SI group (27 %; p?=?0.3).

Conclusions

The SI sling provides comparable objective efficacy to the TO sling at 1 year.

     

Change in urinary storage symptoms following treatment for female stress urinary incontinence

Introduction and hypothesis

Sling surgery is common for stress urinary incontinence (SUI). Yet many women have stress-predominant mixed urinary incontinence (MUI). The change in urgency/urge urinary incontinence (U/UUI) following treatment is not well documented. Our aim was to assess changes in U/UUI in women undergoing a sling placement for MUI and correlate this with improvement in quality of life (QOL).

Methods

This was a retrospective review of women treated for SUI with either an autologous rectus fascia pubovaginal sling (AF-PVS) or synthetic retropubic midurethral sling (MUS). Validated questionnaires—Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire–Short Form (IIQ-7), and visual analog scale (VAS) were obtained pre- and postoperatively. The independent association between change in storage symptoms and subjective cure—as defined by improved overall score on UDI-6, VAS score?≥?7, or both —were assessed using multivariate logistic regression.

Results

Nine hundred and twenty-seven women were identified for inclusion; 718 (77.5 %) had preoperative MUI, of whom 487 (67.8 %) received an MUS and 231 (32.2 %) an AF-PVS. Similar objective cure rates were noted following MUS vs. AF-PVS (78.2 % vs. 71.9 %, p?=?0.315). Subjectively, women treated with MUS experienced greater improvement in U/UUI (72.8 % vs. 57.6 %, p?=?<0.001) than AF-PVS. Multivariate analysis showed MUS patients were more than twice as likely to show subjective improvement in UDI-6 and VAS scores than the AF-PVS cohort. Postoperatively, validated questionnaires were significantly associated with storage symptom outcome.

Conclusions

Patients with U/UUI experience significant symptom improvement following treatment for MUI. QoL assessment following surgery is directly correlated with improvement in U/UUI.

     

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.

     

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.

     

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.

     

King’s Health Questionnaire to assess subjective outcomes after surgical treatment for urinary incontinence: can it be useful?

Introduction and hypothesis

Midurethral slings (MUS) are the mainstay of treatment for stress urinary incontinence, but the definition of success varies widely amongst studies. The King’s Health Questionnaire (KHQ) was designed to evaluate the impact of urinary incontinence on the quality of life. We hypothesised that the KHQ could be useful for postoperative quantitative assessment of subjective outcomes.

Materials and methods

This is a retrospective analysis of 204 patients who underwent incontinence surgery with transobturator MUS between 2004 and 2013. Follow-up was planned at 6, 12 and 24 months and success was evaluated using the cough stress test (objective cure) and the KHQ global score (subjective outcomes). Statistical analysis included receiver operating characteristic (ROC) curves to calculate a cut-off value for the KHQ global score to define subjective cure. The minimal clinically important difference was calculated with a distribution-based method (effect size) to estimate subjective improvement.

Results

Objective cure rates were 97 % and 95 % at 6 and 24 months respectively. ROC curves established the cut-off score at?≤?31 for subjective cure, with sensitivity of 63–100 % and specificity of 82–88 %. Subjective cure rates were 80 % and 85 % at 6 and 24 months respectively. The minimal clinically important difference was set at 10 and an improvement of?≥?10 points was defined as subjective improvement. Rates varied between 10 and 13 %.

Conclusions

This study showed the value of the KHQ as an evaluation tool after UI surgery and determined clinically relevant threshold scores to define subjective outcomes.

     

Five years after midurethral sling surgery for stress incontinence: obesity continues to have an impact on outcomes

Introduction and hypothesis

The objective was to evaluate the impact of preoperative body mass index ≥30 on objective and subjective cure rates 5 years after midurethral sling surgery.

Methods

Secondary analysis of the 5-year results of a randomized clinical trial evaluating tension-free vaginal tape vs transobturator tape surgery. Women (n?=?176) were classified as obese or non-obese based on preoperative height and weight. Women self-reported symptoms and quality of life, and underwent standardized physical examinations and pad-testing. Categorical data were analyzed using Chi-squared or Fisher’s exact tests, continuous data by Mann–Whitney U test. Primary outcome was objective cure defined as <1 g urine lost on pad-test at 5 years post-surgery. Secondary outcomes were subjective cure of incontinence, urinary urge incontinence symptoms, and quality of life scores.

Results

Non-obese women had a higher rate of objective cure, 87.4 % (n?=?83 out of 95) compared with 65.9 % (n?=?29 out of 44) in the obese group (P?=?0.003, risk difference [RD] 21.5 %, 95 % CI 5.9–37.0 %). Subjectively, non-obese women also reported higher rates of cure, 76.7 % (n?=?89 out of 116) compared with 53.6 % (n?=?30 out of 56) of obese women (P?=?0.002, RD 23.2 %, 95 % CI 8.0–38.3 %). Overall rates of urge incontinence symptoms were similar in the two groups, but rates of bothersome symptoms were higher for obese women (58.9 % vs 42.1 %, P?=?0.039, RD 16.8 % 95 % CI 1.1–32.6).

Conclusions

Five years after surgery, obese women continued to experience lower rates of cure compared with non-obese women.

     

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.

     

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.

     

Risk factors for failure of repeat midurethral sling surgery for recurrent or persistent stress urinary incontinence

Introduction and hypothesis

To study the outcomes following repeat midurethral sling (MUS) surgery in patients with persistent or recurrent stress urinary incontinence after failure of primary MUS surgery and risk factors for surgical failure.

Methods

The medical records of 24 patients who underwent repeat MUS surgery at a single tertiary center from January 2004 to February 2014 were reviewed. The types of MUS used for the repeat surgey were transobturator, retropubic and single incision slings. Objective cure was defined as no demonstrable involuntary leakage of urine during increased abdominal pressure in the absence of a detrusor contraction observed during filling cystometry, and subjective cure was defined as a negative response to Urogenital Distress Inventory six (UDI-6) question 3 during follow-up between 6 months and 1 year postoperatively. The change in the inclination angle between the urethra and pubic axis was measured with introital ultrasonography and the cotton swab test performed.

Results

The objective and subjective cure rates were 79.2 % and 75 %, respectively. There were no differences in demographics between the patients with failure of surgery and those with successful surgery. Significant independent risk factors for failure of repeat MUS surgery were a change in cotton swab angle at rest and straining of <30° (OR 4.6, 95 % CI 2.5 – 7.9°), a change in inclination angle of <30° (OR 4.6, 95 % CI 2.5 – 7.9°), intrinsic sphincter deficiency (OR 3.4, 95 % CI 1.8 – 6.1) and a mean urethral closure pressure of <60 cm H₂O (OR 2.9, 95 % CI 1.5 – 4.5). In one patient the bladder was perforated.

Conclusions

Repeat MUS surgery is safe and has a good short-term success rate, both objectively and subjectively, with independent risk factors for failure related to bladder neck hypomobility and poor urethral function.

     

Effect of anesthesia type on perioperative outcomes with a midurethral sling

Introduction and hypothesis

There is no consensus on the most appropriate type of anesthesia for placement of a midurethral sling. Our objective was to compare intra- and perioperative outcomes for this procedure performed under general anesthesia versus monitored anesthesia care.

Methods

Retrospective cohort analysis of women undergoing outpatient placement of synthetic retropubic midurethral sling under general anesthesia (n?=?141) or monitored anesthesia care (n?=?84). Patients undergoing concomitant procedures were excluded. Primary outcome was operating room time. Secondary outcomes included surgical and recovery times, cost, discharge home with a catheter, and postoperative pain and/or nausea.

Results

In the general anesthesia group, both operating room time (mean?±?SD, 67.6?±?13.3 min vs 56.9?±?11.8 min, p?<?0.001) and recovery room time (240.0?±?69.8 min vs 190.1?±?78.3 min, p?<?0.001) were longer, whereas there was no difference in surgical time (30.0?±?8.9 min vs 29.0?±?9.7 min, p?=?0.43). Cost was significantly higher in the general anesthesia group ($4,095?±?715 vs $3,877?±?777, p?=?0.03). There was no difference in rates of bladder perforation (6.4 % vs 11.9 %, p?=?0.33). Patients who underwent general anesthesia had higher rates of discharge with a catheter (27.0 % vs 15.8 %, p?=?0.04).

Conclusion

Monitored anesthesia care may offer significant benefits over general anesthesia in women undergoing retropubic midurethral sling, including shorter operating room and recovery times, lower costs, and less voiding dysfunction in the immediate postoperative period.

     

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.