International Urogynecology Journal

Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months. ESTEEM is a multisite, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure, and need for additional treatment. The final study design was implemented in November 2013 across eight clinical sites in the Pelvic Floor Disorders Network. As of 27 February 2016, 433 total/472 targeted participants had been randomized. We describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision making.

Large bladder masses are typically found to be malignant in nature. We present a case of a large bladder neck mass as a result of previous imprecise collagen injection for urethral bulking. The patient was successfully treated as an outpatient with transurethral excision of the collagen mass combined with post-operative anticholinergic therapy.

The objective of this study was to identify risk factors and urodynamic parameters predictive of mid-urethral sling (MUS) revision surgery that can be used for counseling patients and individualizing risk prediction. Retrospective case-control analysis of 40 sling revisions performed during the 12-year study period were compared to 123 control cases that did not require revision to obtain a 1:3 case-to-control ratio. Demographic, perioperative, and urodynamic data were analyzed, with p < 0.05 as significant. Independent predictors of sling revision were assessed by binary logistic regression models, with risk expressed as adjusted odds ratios. After multiple regression analysis, younger age at time of index MUS placement (aOR 0.93, 95% CI 0.88–0.97), increasing number of cesarean deliveries (CD) (aOR 2.00, 95% CI 1.01–3.96), and concomitant apical prolapse repair during index MUS procedure (aOR 4.63, 95% CI 1.34–15.93) were significant predictors of sling revision. Young age at the time of placement, multiple CD, and concomitant apical prolapse repair were independent factors predictive of sling revision. Giving consideration to risk factors could improve patient counseling and surgical candidate selection.

The aim of this study was to evaluate urinary symptoms in the postpartum period after omission of the bladder flap at the time of primary cesarean delivery. This was a single-blind parallel-group randomized comparison (bladder flap, no bladder flap) in women scheduled for a primary cesarean delivery at 37 weeks gestation or later. The primary outcome was urinary symptom scores at 6–8 weeks postpartum. Secondary outcomes included comparisons of preoperative and postoperative pelvic floor symptom scores and the proportions of symptom bother responses between the study groups. A total 43 women were available for analysis. Randomization was as follows: omission of the bladder flap (n = 22) and bladder flap (n = 21). Demographic characteristics and baseline pelvic floor symptom scores were similar between the groups. The primary outcome, urinary symptom scores at 6–8 weeks postpartum, did not differ significantly between the groups, but urinary symptom bother was significantly higher in women who received a bladder flap. Pelvic floor symptom scores improved significantly following delivery. Urinary symptom scores as measured by the UDI-6 did not differ between women randomized to bladder flap or omission of the bladder flap, but the proportion of women with urinary symptom bother was significantly higher among those who received a bladder flap.

The aim of this study was to compare treatment outcomes 1 year after uterosacral ligament suspension (USLS) with or without concomitant anterior repair (AR) for anterior vaginal wall prolapse resolved under simulated apical support. This retrospective cohort study included 179 women who underwent USLS with or without concomitant AR for Pelvic Organ Prolapse Quantification (POPQ) stage 2–4 anterior vaginal wall prolapse resolved under simulated apical support, and who completed a 1-year follow-up. The primary outcome was composite surgical failure defined as anterior anatomical recurrence (point Ba>0), symptomatic recurrence (presence of vaginal bulge symptoms), or retreatment for prolapse. Secondary outcomes included changes in POPQ values and Urogenital Distress Inventory-6 (UDI-6) scores, perioperative outcomes, and complications. Eighty-six women underwent concomitant AR, and 93 did not. The group receiving AR had more advanced anterior and apical prolapse. Surgical failure rates were significantly higher in the group not receiving AR than in the group receiving AR (21.5% vs 7.0%, p < 0.01). However, there were no differences in the mean point Ba and C values and UDI-6 scores through 12 months postoperatively between the two groups. Operating times were longer, and adverse events, such as immediate postoperative urinary retention and minor wound complications, were more frequent in the group receiving AR (p < 0.05). Concomitant AR at the time of USLS seems to reduce the recurrence of anterior vaginal wall prolapse without significant morbidity. Considering the small difference in anatomical outcomes, a longer follow-up period will be required to confirm this.

The concept of using the pubic bone as a support for the bladder neck and urethra in the treatment of women with genuine stress urinary incontinence is well established, and is applied in traditional procedures such as Marshall-Marchetti-Krantz and the Burch colposuspensions. Recently, minimally invasive techniques, including the use of laparoscopic surgery and pubic bone anchoring systems, have been introduced. These new techniques, attempt to combine the advantages of retropubic procedures while remaining minimally invasive. A search of the English literature was carried out, traditional and new procedures using the pubic bone as a support for the bladder neck and urethra are described, and their efficacy and complications are reviewed and discussed. Traditional procedures have proved to be highly effective and well tolerated, with good long-term outcomes. The early results of innovative minimally invasive techniques are promising, but further experience and longer follow-up is needed to establish their role in the treatment of female stress urinary incontinence.

Defining patient characteristics that alter vascular anatomy at the sacrum is critical for avoiding life-threatening bleeding at the time of sacrocolpopexy. We tested the hypothesis that in thinner/older women, the bifurcations of the aorta and inferior vena cava (IVC) are lower relative to S1 resulting in less space accessible for suture/mesh placement, placing this group at increased risk of major vascular injury. In a retrospective cross-sectional study, CT scans were used to make 2D measurements and a 3D model of the aorta/IVC, intervertebral disc space, and bony anatomy using segmentation and modeling software. For analysis, Spearman’s and Pearson’s correlation, Student’s t test and the Mann-Whitney U test were used along with multivariate analysis of variance. Of eligible women who had undergone abdominal/pelvic CT, 107 were included. The median locations of the aortic and IVC bifurcations utilizing 2D analysis were at the inferior L4 and middle L5 vertebral body, respectively. In 10.2% of patients, the IVC was located at the L5-S1 disc space or lower; however, 3D modeling of this space which allowed assessment of the area below the S1 “drop off” showed that the amount of accessible space for suture/mesh placement was not decreased. Utilizing 2D analysis there was no statistically significant independent correlation between age or adiposity and the aortic or IVC bifurcation. Patients who were both elderly and thinner had a lower aortic bifurcation (p = 0.005) and a trend towards a lower IVC bifurcation (p = 0.082). In 10.2% of women, the IVC bifurcation descended at or below the L5-S1 disc space, suggesting that this group of women is at increased risk of major vascular injury. Patients who were both thin and elderly had lower bifurcations, but there was no difference in accessible surface area for suture placement on 3D analysis. 3D modeling improved visualization of the anatomy beyond the S1 “drop off” and may provide a future tool for surgical planning once predictors of high-risk anatomy are defined.