A prospective study of a single-incision sling at the time of robotic sacrocolpopexy

Introduction and hypothesis

The objective of this study was to evaluate the efficacy and safety of the Miniarc Precise® single-incision sling (American Medical Systems, Minnetonka, MN, USA) placed at the time of a robotic sacrocolpopexy.

Methods

This was a prospective study of a single-incision suburethral sling placed at the time of robotic sacrocolpopexy in women with stress urinary incontinence (SUI) and pelvic organ prolapse. Primary outcome measure was cure at 1 year, defined objectively by a negative cough stress test (CST) and subjectively by a score of “0 or 1” on question 17 of the Pelvic Floor Distress Inventory (PFDI-20): “Do you experience urine leakage related to coughing/sneezing/laughing?” Secondary outcome measures included the change in Urinary Distress Inventory (UDI-6) and Urinary Impact Questionnaire (UIQ-7) scores at 1 year. All sling-related complications were reported. Paired Student’s t test and the Wilcoxon signed-rank test were used for statistical analysis.

Results

One hundred and one patients were included between August 2010 and July 2012. One-year follow-up was available for 97 out of 101 patients (96 %). Objective cure was 90 % and subjective cure was 87 %. Baseline UDI-6 scores improved from 34.8?±?25.1 to 6.7?±?11.2 at 1 year (p?p?Conclusions The addition of a single-incision suburethral sling at the time of robotic sacrocolpopexy in women with SUI resulted in an 87 % cure rate at 1 year.     

Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial

Introduction and hypothesis

We tested the hypothesis that the single-incision sling, TVT-Secur (TVT-S), placed in U position is not inferior to transobturator midurethral sling (TVT-O) for treating stress urinary incontinence (SUI).

Methods

This was a noninferiority, prospective, randomized controlled trial in which women with SUI, confirmed by physical and urodynamic evaluation, were randomly assigned to receive either TVT-O (n?=?56) or TVT-S (n?=?66). Exclusion criteria were voiding dysfunction, detrusor overactivity (DO), and pelvic organ prolapse (POP) beyond the hymen. The primary outcomes were objective and subjective cure rates, which were assessed at the 12-month follow-up visit, defined as negative stress, pad, and urodynamic tests and absence of self-reported SUI symptoms. Secondary outcomes were quality of life (QoL) by King’s Health Questionnaire (KHQ) validated for Portuguese language, postoperative pain, and complication rate. The power of the study was 80 % to test the hypothesis that TVT-S is not inferior to TVT-O by >15 %. Statistical significance was fixed at 5 % (p?<?0.05).

Results

Groups were similar regarding demographic and clinical preoperative parameters. Objective cure rates for TVT-S and TVT-O groups were 84.1 % vs 87 % [90 % confidence interbal (CI) ?15 to 9.8], and subjective cure rates were 92.1 % vs 90.7 % (95 % CI ?11.4 to 6.7), respectively. TVT-S resulted in less postoperative general and thigh pain (p?<?0.001). A few, but not statistically significant different complications, were observed in both groups: vaginal mucosa perforation, urinary retention, urinary infection, tape exposure, and de novo urgency. There was a significant improvement in all KHQ domains in both groups (p?<?0.001).

Conclusion

TVT-S was not inferior to TVT-O for treating SUI at 12-month follow-up.     

75NC007 device for noninvasive stress urinary incontinence management in women: a randomized controlled trial

Introduction and hypothesis

Management of stress urinary incontinence (SUI) with intravaginal devices is an alternative to surgical management, but data of a high level of evidence remain scarce. Our goal was to assess efficacy, tolerance, and acceptability of the 75NC007 intravaginal device for SUI management.

Methods

A phase III, multicenter randomized controlled trial was conducted. After an initial washout period with no treatment, allowing baseline evaluation, women with SUI were randomly assigned to a treatment or control group (no treatment). The primary endpoint was the reduction of incontinence episode frequency (IEF), according to bladder diaries, as compared to baseline. Secondary endpoints were variation of the Urinary Symptom Profile (USP) score, of 24-h pad test, and of CONTILIFE questionnaire scores as compared to baseline. Intent-to-treat and per-protocol analyses were conducted.

Results

Fifty-five patients were enrolled and analyzed (26 controls and 29 treated). The mean relative variations of IEF, SUI USP subscore, and overactive bladder (OAB) USP subscore were more significant in the treatment group than in the control group (?31.7?±?65.1?% vs ?7.6?±?24.5?%, p?=?0.002, ?2.4?±?2.6 vs 0.2?±?2.2, p?=?0.004, and ?1.5?±?2.8 vs 0.2?±?1.8, p?=?0.016, respectively). The dysuria USP subscore was slightly decreased in the treatment group. CONTILIFE scores were slightly improved in the treatment group. Pad test variations were not different between groups. No serious adverse event was noted throughout the entire study.

Conclusions

The 75NC007 intravaginal device is a safe and effective noninvasive treatment of SUI in women.     

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.

     

Measurement of the Q-tip angle before and after tension-free vaginal tape-obturator (TVT-O): preoperative urethral mobility may predict surgical outcome

Introduction and hypothesis

The purpose of this study was to compare the results of the Q-tip test before and after the tension-free vaginal tape-obturator (TVT-O) in women with stress urinary incontinence (SUI) to determine the value of the Q-tip test in predicting the outcome of transobturator tape (TOT).

Methods

Between June 2008 and June 2009, 59 women with SUI who underwent the TVT-O procedure and were followed up for at least 6 months were analyzed. Urethral hypermobility was defined as a maximal straining angle greater than 30° as measured by the Q-tip test. Parameters of evaluation included a comprehensive medical history, physical examination, Q-tip test, stress test, and urodynamic study, which included determination of the Valsalva leak point pressure. Cure was defined as no leakage of urine postoperatively either subjectively or objectively, whereas failure was defined as the objective loss of urine during the stress test.

Results

The patients were divided into two groups according to their preoperative Q-tip angle: <30° (group 1, n?=?21) and ≥30° (group 2, n?=?38). The Q-tip angle decreased significantly in both groups: from 25.9?±?5.98° preoperatively to 18.4?±?7.23° postoperatively in group 1 (p?=?0.04) and from 36.6?±?6.75° preoperatively to 24.1?±?5.48° postoperatively in group 2 (p?=?0.03). The difference was obviously pronounced in group 2. The incontinence cure rate was significantly higher in group 2 (97.4 %) than in group 1 (85.7 %; p?=?0.04).

Conclusions

Our results suggest that mobility of the proximal urethra is associated with a high rate of success of the TVT-O procedure.     

Transvaginal electrical stimulation with surface-EMG biofeedback in managing stress urinary incontinence in women of premenopausal age: a double-blind, placebo-controlled, randomized clinical trial

Introduction and hypothesis

The aim of this study was to evaluate the results of conservative treatment of urodynamic stress urinary incontinence (SUI) using transvaginal electrical stimulation with surface-electromyography-assisted biofeedback (TVES?+?sEMG) in women of premenopausal age.

Methods

One hundred and two patients with SUI were divided into two groups: active (n?=?68) and placebo (n?=?34) TVES?+?sEMG. The treatment lasted for 8 weeks and consisted of two sessions per day. Women were evaluated before and after the intervention by pad test, voiding diary, urodynamic test, and the Incontinence Quality of Life Questionnaire (I-QOL).

Results

Mean urinary leakage on a standard pad test at the end of 8th week was significantly lower in the active than the placebo group (19.5?±?13.6 vs. 39.8?±?28.5). Mean urinary leakage on a 24-h pad test was significantly reduced in the active group at the end of 8th and 16th weeks compared with the placebo group (8.2?±?14.8 vs. 14.6?±?18.9 and 6.1?±?11.4 vs. 18.2?±?20.8, respectively). There was also a significant improvement in muscle strength as measured by the Oxford scale in the active vs the placebo group after 8 and 16 weeks (4.2 vs 2.6 and 4.1 vs 2.7, respectively). No significant difference was found between groups in urodynamic data before and after treatment. At the end of 8th week, the mean I-QOL score in the active vs the placebo group was 78.2?±?17.9 vs 55.9?±?14.2, respectively, and at the end of 16th week 80.8?±?24.1 vs. 50.6?±?14.9, respectively.

Conclusion

Our study showed that TVES?+?sEMG is a trustworthy method of treatment in premenopausal women with SUI; however, its reliability needs to be established.     

Prospective randomized comparison of the transobturator mid-urethral sling with the single-incision sling among women with stress urinary incontinence: 1-year follow-up study

Introduction and hypothesis

The objective was to compare the efficacy and safety of an innovative single-incision sling (SIS) with the inside-out transobturator sling (TOT) in the treatment of female stress urinary incontinence (SUI).

Methods

A prospective randomized trial was performed in a tertiary referral urogynecology center from January 2012 to December 2013. The study included women with pure urodynamic SUI. Patients were randomized to either the SIS or the TOT anti-incontinence procedure. Surgery duration, blood loss, and groin pain scores were recorded for each patient. The 1-year follow-up visit included objective and subjective cure parameters, postoperative de novo urgency, complications, and the impact on the patient’s life quality.

Results

Of 285 patients assessed for eligibility, a total of 93 patients (32.6 %) were randomized into TOT (n?=?48) and SIS groups (n?=?45). There were no significant differences in either operating time or blood loss. A statistically significant difference between the two groups was found in pain scores three (5.6?±?1.8 vs 3.1?±?2.1, p?<?0.001) and 12 h postoperatively (3.8?±?1.7 vs 2.1?±?1.7, p?<?0.001). After 1 year, there were no significant differences between the TOT and SIS groups in objective cure rates (87.0 % vs 90.9 %; p?=?0.399) or patient-reported success rates (91.3 % vs 93.2 %; p?=?0.999). Incidence of postoperative de novo urgency did not differ between TOT and SIS patients. Both groups registered a significant improvement in quality of life.

Conclusions

The Ophira SIS procedure has 1-year success rates comparable to standard TOT with significantly less groin pain in the early postoperative period. Both methods were safe and effective in terms of postoperative urgency and life quality improvement.

     

An inelastic retropubic suburethral sling in women with intrinsic sphincter deficiency

Introduction and hypothesis

We evaluated outcomes of an inelastic retropubic sling in patients with intrinsic sphincteric deficiency (ISD).

Methods

This is a retrospective review of women diagnosed with ISD according to urodynamic parameters who underwent a retropubic suburethral sling surgery using a tape with minimal elasticity. All patients in the study where followed up at 2, 6, and 24 weeks and yearly. Outcome measures included self-assessed satisfaction, daily incontinence episodes and pad usage, standardized stress test, postvoid residual volume, and surgical complications.

Results

Two hundred and forty-seven patients were involved in this study, with a median follow-up of 43 [interquartile range (IQR) 22–77] weeks and a minimum of 12 weeks. Two patients (0.008 %) had a positive stress test postoperatively. There was a decrease in daily incontinence events (median 1.5–0) (p?<?0.001) and pad usage per day (median 1.5–0) (p?<?0.001). Two hundred and sixteen (87.4 %) patients reported subjective improvement in symptoms. Urinary retention was found in 18 (7.2 %) patients, and 19 (7.7 %) patients required reintervention, mostly with bulking agent injections for persistent incontinence. No tape-related mesh exposures were reported.

Conclusion

Retropubic suburethral inelastic slings represent a good option for treating patients with ISD, with satisfactory continent rates and low postoperative complications.     

Evaluation of xenogenic extracellular matrices as adjuvant scaffolds for the treatment of stress urinary incontinence

Introduction and hypothesis

Tissue-engineered biomaterials have shown recent promise as adjuvant scaffolds for treating stress urinary incontinence (SUI). The objective of the present study was to compare their mechanical and regenerative properties with synthetic biomaterials in this urogynaecological setting.

Methods

The biomechanical properties of polypropylene (Serasis®; n?=?12), four-ply urinary bladder matrix (UBM; n?=?12) and four-ply small intestinal submucosa (SIS; n?=?12) were determined with uni-axial tensile testing protocols and compared with stress–strain curves. Subsequently, human dermal fibroblasts (2.5?×?10⁴cells/cm²) were cultured onto each biomaterial under conventional laboratory growth conditions for 12 consecutive days. Attachment, viability, and proliferative activity of fibroblasts were evaluated and compared using quantitative viability indicators and scanning electron microscopy.

Results

There were no significant differences in the biomechanical properties of each biomaterial assessed. Incremental stiffness at 0–10 % strain measured 5.73?±?0.36 MPa for polypropylene compared with 8.23?±?0.92 MPa and 6.81?±?0.83 MPa for SIS and UBM respectively (p?>?0.05). Viability and proliferative activity of fibroblasts differed significantly on all three biomaterials with the luminal and abluminal surfaces of the UBM demonstrating significantly greater rates of fibroblast proliferation compared with polypropylene and SIS (p?<?0.01).

Conclusion

This is the first comparative study on porcine UBM, porcine SIS, and synthetic polypropylene as adjuvant scaffolds for the treatment of SUI. Our results demonstrate that porcine UBM may provide an attractive alternative owing to its superior remodelling potential.     

Surgical preparation: are patients “ready” for stress urinary incontinence surgery?

Introduction and hypothesis

Patient preparedness for stress urinary incontinence (SUI) surgery is associated with improvements in post-operative satisfaction, symptoms and quality of life (QoL). This planned secondary analysis examined the association of patient preparedness with surgical outcomes, treatment satisfaction and quality of life.

Methods

The ValUE trial compared the effect of pre-operative urodynamic studies with a standardized office evaluation of outcomes of SUI surgery at 1 year. In addition to primary and secondary outcome measures, patient satisfaction with treatment was measured using a five-point Likert scale (very dissatisfied to very satisfied) that queried subjects to rate the treatment’s effect on overall incontinence, urge incontinence, SUI, and frequency. Preparedness for surgery was assessed using an 11-question Patient Preparedness Questionnaire (PPQ).

Results

Based on PPQ question 11, 4 out of 5 (81 %) of women reported they “agreed” or “strongly agreed” that they were prepared for surgery. Selected demographic and clinical characteristics were similar in unprepared and prepared women. Among SUI severity baseline measures, total UDI score was significantly but weakly associated with preparedness (question 11 of the PPQ; Spearman's r?=?0.13, p?=?0.001). Although preparedness for surgery was not associated with successful outcomes, it was associated with satisfaction (r _s?=?0.11, p?=?0.02) and larger PGI-S improvement (increase; p?=?0.008).

Conclusions

Approximately half (48 %) of women “strongly agreed” that they felt prepared for SUI. Women with higher pre-operative preparedness scores were more satisfied, although surgical outcomes did not differ.     

The effectiveness of urinary incontinence treatments measured using the 15D Health-Related Quality of Life instrument

Introduction and hypothesis

The health-related quality of life (HRQoL) is significantly impaired among urinary incontinent women and the effectiveness of urinary incontinence (UI) treatment should be measured using an HRQoL instrument.

Methods

A prospective, observational study evaluating the HRQoL of 178 non-selected UI patients referred for routine treatment at the Helsinki University Central Hospital between the years 2004 and 2010. HRQoL was assessed using the generic 15D questionnaire on four occasions: before treatment, 6 and 18 months after treatment, and after a median follow-up of 5 years. The HRQoL of the patients was compared with that of an age-standardized Finnish female population.

Results

Compared with the general population, the baseline total HRQoL score of the patients was significantly impaired (p?<?0.001). It was worse among the urge or mixed (UUI (±SUI)) incontinence patients than among the stress incontinence (SUI) patients (p?=?0.035). During follow-up, HRQoL improved and the improvement was more substantial among the operatively than among the conservatively treated patients (p?=?0.027). Statistically significant improvement was only seen in the SUI group (Δ?+?0.021, 95 % CI 0.005–0.036), but clinically relevant improvement was also found in the operatively treated UUI (±SUI) group. The maximum benefit of treatment was reached between at 2 and 3 years.

Conclusions

15D is a sensitive tool for monitoring the change in HRQoL and could be implemented into clinical practice. Operative treatment of UI is effective when measured by improved HRQoL. Not only SUI patients, but also selected patients with an urgency component may benefit from surgery.     

A prospective study of transobturator tape as treatment for stress urinary incontinence after transvaginal mesh repair

Introduction and hypothesis

The transobturator suburethral sling is a common surgical treatment for stress urinary incontinence (SUI). In patients with incontinence after trocar-guided transvaginal mesh repair (Prolift?), data on outcome remain limited. In the present study, we hypothesized that transobturator tape in such cases is assumed to be as effective as surgery alone.

Methods

This was a prospective analysis of outcomes of transobturator slings in women who had undergone transvaginal mesh repair and in those who underwent sling surgery alone (controls). Objective cure was defined as the absence of urinary leakage during the stress test at filling cystometry and a negative cough test during pelvic examination. The success rates were evaluated 3–6 months postoperatively.

Results

One hundred women were recruited for the study. Compared to the control group, women after transvaginal mesh repair had a significantly lower objective success rate (62 vs 86 %, p?=?0.005) and poorer bladder neck mobility (0.5?±?0.8 vs 1.1?±?0.5 cm, p?=?0.001).

Conclusions

The transobturator sling has lower objective success rate in women after transvaginal mesh that may be due to decreased bladder neck mobility. Patients with post-mesh repair SUI who opt for sling surgery should be informed of these less satisfactory outcomes during preoperative counseling.     

Coital incontinence: a factor for deteriorated health-related quality of life and sexual function in women with urodynamic stress urinary incontinence

Introduction and hypothesis

To assess the impact of coital incontinence (CI) on health-related quality of life (HRQoL) and quality of sexual function (QSF) in women with urodynamic stress urinary incontinence (SUI).

Methods

Women were recruited for this cross-sectional study from among 289 patients with lower urinary tract symptoms, underwent clinical and urodynamic evaluation. Of these 289 women, 127 sexually active women with SUI completed the King’s Health Questionnaire (KHQ) and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ), of whom 97 were enrolled for the study. The study group comprised 53 women with CI occurring ‘sometimes’, ‘usually’ or ‘always’, and the control group comprised 44 women without CI. Total and individual domain scores were evaluated.

Results

CI was reported by 65.35 % of the women. The frequency of CI was correlated with lower educational level and higher body mass index (r?=?0.22 and r?=?0.23, respectively; p?=?0.01). The KHQ results showed significantly lower HRQoL in women with CI in all domains (p?<?0.05) apart from Sleep/energy’ (p?=?0.054). PISQ revealed no significant differences in QSF in the Behavioral/emotive and Partner–related domains (34.3?±?10.0 vs. 33.0?±?12.2 and 18.0?±?2.9 vs. 18.2?±?3.6, respectively). Women with CI reported a significantly lower QSF in the Physical domain (29.1?±?6.6 vs. 35.0?±?4.6, p?=?0.001), and the total PISQ score was lower but the difference was not significant (81.4?±?14.3 vs. 86.2?±?16.5). Total PISQ score was correlated with age (r?=??0.28, p?=?0.001). Women with CI were significantly more likely to admit that fear of incontinence or fear of embarrassment restricted their sexual activity (p?<?0.001).

Conclusions

A large percentage (65.35 %) of women with SUI reported CI, which had a negative impact on HRQoL and QSF in the Physical domain, but no significant impact on overall QSF.

     

Preoperative clinical, demographic, and urodynamic measures associated with failure to demonstrate urodynamic stress incontinence in women enrolled in two randomized clinical trials of surgery for stress urinary incontinence

Introduction and hypothesis

The unexpected absence of urodynamic stress incontinence (USI) in women planning surgery for stress urinary incontinence (SUI) is a challenge to surgeons. We examined the prevalence and clinical and demographic factors associated at baseline (preoperatively) with the unexpected absence of USI among study participants of two multicenter randomized clinical trials of surgery for treating SUI.

Methods

Women with SUI symptoms and positive stress tests on physical examination enrolled in two separate clinical trials—one comparing the autologous fascial sling with the Burch colposuspension [Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr), and the other comparing the retropubic mid-urethral sling with the transobturator midurethral sling [Trial of Mid-Urethral Slings (TOMUS)]—were evaluated for USI preoperatively. The association of clinical, demographic, and urodynamic parameters was examined in women without USI in univariate and multivariate analyses.

Results

Overall, 144 of 1,233 women (11.7 %) enrolled in the two studies showed no USI. These women had a significantly lower mean volume at maximum cystometric capacity than those with USI (347.5 vs. 395.8 in SISTEr, p?=?0.012), (315.2 vs. 358.2 in TOMUS, p?=?0.003) and a lower mean number of daily accidents reported on a 3-day diary (2.2 vs 2.7 in SISTEr, p?=?0.030) (1.7 vs 2.7 in TOMUS, p?<?0.001). Additionally, those without demonstrable USI were more likely to have Pelvic Organ Prolapse Quantification (POP-Q) stage III/IV (31.7 % vs 14.4 % in SISTEr, p?=?0.002), (15.5 % vs 6.9 % in TOMUS, p?=?0.025). SUI severity as recorded on the Urogenital Distress Inventory (UDI) correlated strongly with the presence of USI in both studies.

Conclusions

We observed that about one of eight women planning surgery for SUI does not show USI. Stage 3/4 POP was strongly associated with the unexpected absence of USI. A diminished urodynamic bladder capacity among women who did not display USI may reflect an inability to reach the limits of capacity during urodynamics, at which these women normally leak.     

Minimum 1-year results of mesh spiral-sling procedure in managing refractory and primary disabling stress urinary incontinence

Introduction and hypothesis

We present our minimum 1-year results with a mesh spiral-sling procedure (MSSP) for managing refractory and disabling stress urinary incontinence (SUI) in women.

Methods

Thirty-four women were treated with MSSP between 2007 and 2011. Six had incomplete data and were excluded from analysis. Study cohort comprised 21 women with refractory (mean number of previous surgeries 2.2; range 1–6) and seen with primary disabling SUI. All patients had marked intrinsic sphincter deficiency (ISD) with a Valsalva leak-point pressure (VLPP) <60 cm H₂O. Preoperative workup included assessing the impact of voiding symptoms using the International Consultation on Incontinence Questionnaire—Short Form (ICIQ-SF), estimating the daily number of pads, and urodynamic studies. Preoperative and postoperative findings were compared using the Wilcoxon signed-rank test.

Results

Intraoperative unilateral bladder-neck perforation occurred in two women during dorsal urethrolysis. With a mean follow-up of 26 months (range 12–48), SUI was cured in 71.4 % of patients. Distal urethral reconstruction with vaginal mucosal flaps was performed in two patients with short urethral length (<2.5 cm) due to recurrence of SUI 10 months after MSSP. Mean ICIQ-SF score decreased from 19.4?±?3.6 preoperatively to 7.3?±?2.8 postoperatively (p?=?0.001). Mean daily pad number decreased from 5.2 preoperatively to 1.2 postoperatively (p?=?0.02). Urethral or vaginal erosion was not observed in any case during follow-up.

Conclusion

Using spiral slings may be a viable option in managing refractory and disabling SUI.     

Evaluating the porcine dermis graft InteXen® in three-compartment transvaginal pelvic organ prolapse repair

Introduction and hypothesis

The aim was to assess the efficacy of three-compartment pelvic organ prolapse (POP) vaginal repair using the InteXen® biocompatible porcine dermal graft as compared to traditional colporrhaphy with sacrospinous ligament suspension.

Methods

Preoperative, operative, postoperative and follow-up data were collected retrospectively. Objective recurrence was defined as POP quantification ≥ stage II and subjective recurrence as a symptomatic bulge.

Results

Each group consisted of 63 patients. Surgery time was longer using InteXen® (72?±?24.5 vs 55?±?23.5 min, p?=?0.0002). Length of hospital stay (4.6?±?1.6 vs 4.9?±?2.1 days, p?=?0.34) as well as duration of follow-up (37.1 vs 35.7 months, p?=?0.45) were equivalent between the two groups. No case of mesh erosion or infection was noted. The objective (17% vs 8%, p?=?0.12) and subjective recurrence rates (13% vs 5%, p?=?0.12) between the two groups were not statistically different.

Conclusions

InteXen® was well tolerated but had similar efficacy to traditional colporrhaphy and sacrospinous ligament suspension.     

Comparing the risk of urethrolysis for the treatment of voiding dysfunction between two retropubic mesh slings: a case-control study

Introduction and hypothesis

Long-term outcome data exist with Gynecare TVT? tension-free support for incontinence (TVT), yet few comparisons have been made to newer retropubic sling delivery systems, especially with regards to urethrolysis for postoperative voiding dysfunction. Our objective was to compare the odds of urethrolysis for the treatment of voiding dysfunction between two retropubic sling systems.

Methods

We performed a case–control study comparing the risk of urethrolysis between TVT versus the Bard ALIGN® Urethral Support System (Bard Align). We identified surgical procedures described as urethrolysis, sling revision, loosening, or lysis performed for the treatment of voiding dysfunction by urogynecologists at Duke University between January 2007 and June 2011. Slings placed at outside institutions were excluded. Controls were matched for both concomitant prolapse procedures and academic year.

Results

Of 818 total slings placed during the study period, there were 28 (3.4 %) urethrolysis cases, which were matched to 84 controls. Among urethrolysis cases, 6/28 (21.4 %) had received TVT, while 22/28 (78.6 %) had received Bard Align slings. Of the 84 matched controls, 30/84 (35.7 %) had undergone TVT and 54/84 (64.3 %) had undergone Bard Align. There was no significant difference in the odds of urethrolysis following the use of TVT or Bard Align [odds ratio (OR) 2.00, 95 % confidence interval (CI) 0.74–5.50]. In a conditional logistic regression model, which adjusted for age, body mass index, prior anti-incontinence or prolapse surgery, and postvoid residual, there remained no significant difference in odds of urethrolysis between the two sling types (OR 1.50, 95 % CI 0.42–5.33).

Conclusions

Despite different instrument designs, there was no significant difference in the risk of urethrolysis following TVT or Bard Align retropubic sling.     

Pelvic organ prolapse surgery with and without tension-free vaginal tape in women with occult or asymptomatic urodynamic stress incontinence: a randomised controlled trial

Introduction

We set out to determine if insertion of a retropubic tension-free vaginal tape (TVT) sling at the time of pelvic organ prolapse surgery improves continence outcomes in women with pre-operative occult stress incontinence (OSI) or asymptomatic urodynamic stress incontinence (USI).

Methods

We conducted a randomised controlled study of prolapse surgery with or without a TVT midurethral sling. The pre- and post-operative assessment at 6 months included history, physical examination and urodynamic testing. Quality of life (QOL) and treatment success was assessed with the UDI-6 SF, IIQ-7 SF and a numerical success score. The primary outcome was symptomatic stress urinary incontinence (SUI) requiring continence surgery (TVT) at 6 months. Long-term follow-up continued to a minimum of 24 months. Secondary outcomes were quality of life parameters.

Results

Eighty women received prolapse surgery alone (n?=?43) or prolapse surgery with concurrent TVT (n?=?37). Six months following prolapse surgery 3 out of 43 (7 %) patients in the no TVT group requested sling surgery compared with 0 out of 37 (0 %) in the TVT group (ARR 7 % [95 %CI: 3 to 19 %], p?=?0.11). After 24 months there was one further participant in the no TVT group who received a TVT for treatment of SUI compared with none in the TVT group (4 out of 43, 9.3 % versus 0 out of 37; ARR 9.3 % [95 %CI: ?1 to 22 %], p?=?0.06). Both groups showed improvement in QOL difference scores for within-group analysis, without difference between groups.

Conclusion

These results support a policy that routine insertion of a sling in women with OSI at the time of prolapse repair is questionable and should be subject to shared decision-making between clinician and patient.     

Prospective randomized trial comparing synthetic vs biological out-in transobturator tape: a mean 3-year follow-up study

Introduction and hypothesis

The aim of this study was to prospectively and randomly compare the outcome of surgical treatment of female stress urinary incontinence (SUI) using the same outside–inside transobturator technique with biological (PelviLaceTO®) or synthetic (UretexTO®) material sling, evaluating if the biological material can prevent vaginal erosion retaining the “cure rate” of this surgical technique.

Methods

Seventy patients with SUI were selected, randomly assigned to either UretexTO® (n?=?34) or PelviLaceTO® (n?=?36), and underwent the same surgery.

Results

There is no significant difference between two study arms with regard to objective and subjective cure rates and quality of life. In both groups we had an overlap cure rate (UretexTO® group 88.2% vs PelviLaceTO® group 88.8%) at mean 3 years follow-up. It found no perioperative complications nor vaginal erosions.

Conclusions

UretexTO® and PelviLaceTO® are two similarly safe and efficient slings in the management of SUI, with a good patient satisfaction and without any complications.     

Comparison of Gastrojejunal Anastomosis Techniques in Laparoscopic Roux-en-Y Gastric Bypass: Gastrojejunal Stricture Rate and Effect on Subsequent Weight Loss

Background

Different gastrojejunal anastomotic (GJA) techniques have been described in laparoscopic Roux-en-Y gastric bypass (LRYGB). There is conflicting data on whether one technique is superior to the other. We aimed to compare hand-sewn (HSA), circular-stapled (CSA) and linear-stapled (LSA) anastomotic techniques in terms of stricture rates and their impact on subsequent weight loss.

Methods

A prospectively collected database was used to identify patients undergoing LRYGB surgery between March 2005 and May 2012. Anastomotic technique (HSA, CSA, LSA) was performed according to individual surgeon preference. The database recorded patient demographics, relevant comorbidities and the type of GJA performed. Serial weight measurements and percentage excess weight loss (%EWL) were available at defined follow-up intervals.

Results

Included in the data were 426 patients, divided between HSA (n?=?174, 40.8 %), CSA (n?=?110, 25.8 %) and LSA (n?=?142, 33.3 %). There was no significant difference in the stricture rates (HSA n?=?17, 9.72 %; CSA n?=?9, 8.18 %; LSA n?=?8, 5.63 %; p?=?0.4006). Weight loss was similar between the three techniques (HSA, CSA and LSA) at 3 months (40.6 %?±?16.2 % vs 35.92 %?±?21.42 % vs 48.21 %?±?14.79 %; p?=?0.0821), 6 months (61.48 %?±?23.94 % vs 58.16 %?±?27.31 % vs 60.18 %?±?22.26 %; p?=?0.2296), 12 months (72.94 %?±?19.93 % vs 69.72?±?21.42 % vs 66.05 %?±?17.75 %; p?=?0.0617) and 24 months (73.29 %?±?22.31 % vs 68.75 %?±?24.71 % vs 69.40 %?±?23.10 %; p?=?0.7242), respectively. The stricture group lost significantly greater weight (%EWL) within the first 3 months compared to the non-stricture group (45.39 %?±?16.82 % vs 39.22 %?±?21.93 %; p?=?0.0340); however, this difference had resolved at 6 months (61.29 %?±?18.50 % vs 59.79 %?±?23.03 %; p?=?0.8802) and 12 months (71.59 %?±?18.67 % vs 68.69 %?±?22.19 %; p?=?0.5970).

Conclusions

There was no significant difference in the rate of strictures between the three techniques, although the linear technique appears to have the lowest requirement for post-operative dilatation. The re-intervention rate will, in part, be dictated by the threshold for endoscopy, which will vary between units. Weight loss was similar between the three anastomotic techniques. Surgeons should use techniques that they are most familiar with, as stricture and weight loss rates are not significantly different.