Amanda B. White

Sling surgery for stress urinary incontinence in women: a systematic review and metaanalysis.

OBJECTIVE Understanding the long-term comparative effectiveness of competing surgical repairs is essential as failures after primary interventions for stress urinary incontinence (SUI) may result in a third of women requiring repeat surgery. STUDY DESIGN We conducted a systematic review including English-language randomized controlled trials from 1990 through April 2013 with a minimum 12 months of follow-up comparing a sling procedure for SUI to another sling or Burch urethropexy. When at least 3 randomized controlled trials compared the same surgeries for the same outcome, we performed random effects model metaanalyses to estimate pooled odds ratios (ORs). RESULTS For midurethral slings (MUS) vs Burch, metaanalysis of objective cure showed no significant difference (OR, 1.18; 95% confidence interval [CI], 0.73-1.89). Therefore, we suggest either intervention; the decision should balance potential adverse events (AEs) and concomitant surgeries. For women considering pubovaginal sling vs Burch, the evidence favored slings for both subjective and objective cure. We recommend pubovaginal sling to maximize cure outcomes. For pubovaginal slings vs MUS, metaanalysis of subjective cure favored MUS (OR, 0.40; 95% CI, 0.18-0.85). Therefore, we recommend MUS. For obturator slings vs retropubic MUS, metaanalyses for both objective (OR, 1.16; 95% CI, 0.93-1.45) and subjective cure (OR, 1.17; 95% CI, 0.91-1.51) favored retropubic slings but were not significant. Metaanalysis of satisfaction outcomes favored obturator slings but was not significant (OR, 0.77; 95% CI, 0.52-1.13). AEs were variable between slings; metaanalysis showed overactive bladder symptoms were more common following retropubic slings (OR, 1.413; 95% CI, 1.01-1.98, P = .046). We recommend either retropubic or obturator slings for cure outcomes; the decision should balance AEs. For minislings vs full-length MUS, metaanalyses of objective (OR, 4.16; 95% CI, 2.15-8.05) and subjective (OR, 2.65; 95% CI, 1.36-5.17) cure both significantly favored full-length slings. Therefore, we recommend a full-length MUS. CONCLUSION Surgical procedures for SUI differ for success rates and complications, and both should be incorporated into surgical decision-making. Low- to high-quality evidence permitted mostly level-1 recommendations when guidelines were possible.

Anterior abdominal wall nerve and vessel anatomy: clinical implications for gynecologic surgery

OBJECTIVE We sought to describe relationships of clinically relevant nerves and vessels of the anterior abdominal wall. STUDY DESIGN The ilioinguinal and iliohypogastric nerves and inferior epigastric vessels were dissected in 11 unembalmed female cadavers. Distances from surface landmarks and common incision sites were recorded. Additional surface measurements were taken in 7 other specimens with and without insufflation. RESULTS The ilioinguinal nerve emerged through the internal oblique: mean (range), 2.5 (1.1-5.1) cm medial and 2.4 (0-5.3) cm inferior to the anterior superior iliac spine (ASIS). The iliohypogastric emerged 2.5 (0-4.6) cm medial and 2.0 (0-4.6) cm inferior. Inferior epigastric vessels were 3.7 (2.6-5.5) cm from midline at the level of the ASIS and always lateral to the rectus muscles at a level 2 cm superior to the pubic symphysis. CONCLUSION Risk of anterior abdominal wall nerve and vessel injury is minimized when lateral trocars are placed superior to the ASISs and >6 cm from midline and low transverse fascial incisions are not extended beyond the lateral borders of the rectus muscles.

Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial - Design and methods

Background The primary aims of this trial are to determine whether the use of a concomitant prophylactic anti-incontinence procedure may prevent stress urinary incontinence symptom development in women undergoing vaginal prolapse surgery and to evaluate the cost-effectiveness of this prophylactic approach. Purpose To present the rationale and design of a randomized controlled surgical trial (RCT), the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) Trial highlighting the challenges in the design and implementation. Methods The challenges of implementing this surgical trial combined with a cost-effectiveness study and patient preference group are discussed including the study design, ethical issues regarding use of sham incision, maintaining the masking of study staff, and pragmatic difficulties encountered in the collection of cost data. The trial is conducted by the NICHD-funded Pelvic Floor Disorders Network. Results The ongoing OPUS trial started enrollment in May 2007 with a planned accrual of 350. The use of sham incision was generally well accepted but the collection of cost data using conventional billing forms was found to potentially unmask key study personnel. This necessitated changes in the study forms and planned timing for collection of cost data. To date, the enrollment to the patient preference group has been lower than the limit established by the protocol suggesting a willingness on the part of women to participate in the randomization. Limitations Given the invasive nature of surgical intervention trials, potential participants may be reluctant to accept random assignment, potentially impacting generalizability. Conclusion Findings from the OPUS trial will provide important information that will help surgeons to better counsel women on the benefits and risks of concomitant prophylactic anti-incontinence procedure at the time of vaginal surgery for prolapse. The implementation of the OPUS trial has necessitated that investigators consider ethical issues up front, remain flexible with regards to data collection and be constantly aware of unanticipated opportunities for unmasking. Future surgical trials should be aware of potential challenges in maintaining masking and collection of cost-related information. Clinical Trials 2009; 6: 162—171. http://ctj.sagepub.com

Effect of myogenic stem cells on contractile properties of the repaired and unrepaired transected external anal sphincter in an animal model

OBJECTIVE: To estimate the effect of myogenic stem cells on contractile function of the external anal sphincter after transection with or without repair in an animal model. METHODS: One hundred twenty virginal female rats were randomly assinged to repair (n=60) or no repair (n=60) after anal sphincter transection. Animals were further divided into two groups: 40-microliter injection at the transection site with either phosphate-buffered solution (control) or myogenic stem cells (3.2×106 cells). Animals were killed at 7, 21, or 90 days, and the anal sphincter complex dissected and analyzed for contractile function. RESULTS: Contractile function of the external anal sphincter was severely impaired 7 days after sphincter transection with or without repair. Twitch tension, maximal tetanic contraction, and maximal contractile force in response to electrical field stimulation improved significantly with time after sphincter repair. Injection of myogenic stem cells in the anal sphincter at the time of repair resulted in superior contractile function at both 7 days and 90 days compared with controls. Interestingly, contractile function of the nonrepaired external anal sphincter did not improve with time with or without myogenic stem cells. Indicators of denervation (fatigue and twitch or tetany ratios) did not change among groups. CONCLUSION: In this animal model, injection of myogenic stem cells at the time of external anal sphincter repair resulted in enhanced contractile function at 90 days compared with repair alone. Without repair, function of the external anal sphincter was not improved by stem cell therapy at any time point. These results suggest that addition of myogenic stem cells improves both acute and long-term function of the external anal sphincter after mechanical injury.

Antibiotic prophylaxis for selected gynecologic surgeries

Antibiotic prophylaxis for surgery is commonly used and is recommended by multiple organizations.

Optimal location and orientation of suture placement in abdominal sacrocolpopexy.

OBJECTIVE: To estimate the strongest location and optimal orientation of suture placement in the anterior longitudinal ligament for abdominal sacrocolpopexy in female cadavers. METHODS: The anterior longitudinal ligament was exposed below the level of the aortic bifurcation in 23 unembalmed female cadavers. To the right of midline of the vertebral column, sutures were placed in a horizontal orientation into the ligament at the sacral promontory, 1 and 2 cm above (sacral promontory+1 and sacral promontory+2), and 1, 2, and 3 cm below (sacral promontory–1, sacral promontory–2 and sacral promontory–3). At these same locations, but to the left of midline, sutures were placed in a vertical orientation. Pull-out force and ligament thickness at each level of testing were measured. Data were analyzed using Student t test and repeated measures analysis of variance. RESULTS: Sutures (either horizontally or vertically placed) had greater pull-out strengths at or above, compared with those placed below, the level of the sacral promontory. At sacral promontory and sacral promontory+1, there were no differences in the pull-out strengths of the ligament when sutures were placed in either orientation. However, horizontally placed sutures had significantly greater pull-out strengths than vertically placed sutures at sacral promontory+2, sacral promontory–1 and sacral promontory–2. Ligament thickness decreased from 2 cm above (mean±standard error of the mean sacral promontory+2, 1.8±0.1 mm) to 3 cm below (sacral promontory–3, 1.3±0.1 mm) the sacral promontory. CONCLUSION: Sutures placed in the anterior longitudinal ligament at or above the sacral promontory are more secure than those placed below. Horizontally oriented sutures should be considered for mesh attachment below the sacral promontory because they are significantly stronger when compared with vertically placed sutures. LEVEL OF EVIDENCE: III

A retrospective multicenter study on outcomes after midurethral polypropylene sling revision for voiding dysfunction

Objectives: The purpose of this study was to determine outcomes of sling revision after midurethral sling (MUS) placement and whether timing of sling revision affected those outcomes. Materials and Methods: This is a multicenter study including patients who underwent MUS placement and subsequent sling revision secondary to voiding dysfunction. Diagnostic outcomes before and after sling revision were compared for all sling revision patients with complete data. Logistic regression analyses were performed to determine if revision timing predicted voiding dysfunction and stress incontinence. Results: One hundred seventy-five patients who met the study criteria had complete data. Overall, 70% (133) of MUS were retropubic and 30% (56) were obturator slings. Midurethral sling revision was accomplished by cutting (54%), excision (29%), and pulling down on the mesh (18%). Stress urinary incontinence (SUI) resolved in 38%, urinary tract infections (UTIs) in 69%, and overactive bladder (OAB) in 75%. In comparison, 21% experienced de novo SUI; 18%, de novo UTIs; and 12%, de novo OAB symptoms after revision. Voiding dysfunction resolved in 80%, however 10% experienced new voiding dysfunction symptoms. Retropubic slings displayed more voiding dysfunction, higher de novo/worsened OAB, and more UTIs after revision than obturator slings. Sling revision timing did not predict persistent voiding dysfunction but did predict SUI with earlier revision (≤2 weeks) resulting in less postrevision SUI when compared to revisions at 15-90 days or greater than 90 days. The method of sling revision (cut, excised, pulled down) did not predict SUI, OAB, or obstructive voiding symptoms. Conclusions: Sling revision resolves voiding dysfunction symptoms, UTIs and post-sling OAB symptoms in the majority of patients. Resolution of voiding dysfunction is independent of method and timing of revision; however earlier revision is associated with decreased postrevision SUI.

Risk factors leading to midurethral sling revision: a multicenter case-control study

Introduction and hypothesisTo determine risk factors for sling revision after midurethral sling (MUS) placement.MethodsThis multicenter case-control study included patients who underwent MUS placement and subsequent revision secondary to voiding dysfunction from January 1999–2007 from nine Urogynecology centers across the USA. Direct logistic regression analysis was used to determine which diagnostic variables predicted sling revision.ResultsOf the patients, 197 met the study criteria. Patient demographics, urodynamic findings, and operative differences did not increase the risk for sling revision. Risk factors for sling revision did include: pre-existing voiding symptoms (OR 2.76, 95% CI 1.32–5.79; p = 0.004) retropubic sling type (OR = 2.28, 95% CI 1.08–4.78; p = 0.04) and concurrent surgery (OR = 4.88, 95% CI 2.16–11.05; p < 0.001)ConclusionsThis study determined that pre-existing obstructive voiding symptoms, retropubic sling type, and concurrent surgery at the time of sling placement are risk factors for sling revision.

Recovery of external anal sphincter contractile function after prolonged vaginal distention or sphincter transection in an animal model

OBJECTIVE: To estimate the effect of prolonged vaginal distention and anal sphincter transection on contractile properties of the external anal sphincter as a function of time. METHODS: One hundred thirty-nine young female virginal rats were randomly assigned into four treatment groups (sham, vaginal distention, transection of anal sphincter plus repair, or combined distention and transection plus repair). After 3 days, 3 months, or 6 months, the anal sphincter complex was analyzed for peak force of twitch tension, peak tetanic force, fatigue, and maximal responses to electrical field stimulation. Statistical analysis was performed using analysis of variance (Student-Neuman-Keuls). RESULTS: After 3 days, vaginal balloon distention, anal sphincter transection with repair, and combined distention and transection plus repair resulted in compromise of maximal tetanic contraction and electrical field stimulated force generation. Twitch tension, and resistance to fatigue were also significantly decreased in animals with anal sphincter disruption and repair with and without vaginal distention at 3 days. Contractile function of the external anal sphincter, however, was fully recovered by 3 months and was sustained at 6 months in all treatment groups. The time course of repair was slower in animals with sphincter laceration. CONCLUSION: Anal sphincter transection with or without antecedent prolonged vaginal distention results in severe compromise of external anal sphincter function in the immediate period after injury. In this animal model, complete recovery of external anal sphincter function occurs 3 months after initial insult.

Validation of the activities assessment scale in women undergoing pelvic reconstructive surgery.

Objective The Activities Assessment Scale (AAS) is a 13-item postoperative functional activity scale validated in men who underwent hernia surgery. We evaluated the psychometric characteristics of the AAS in women who underwent vaginal surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Methods Participants included 163 women with POP and SUI enrolled in a randomized trial comparing sacrospinous ligament fixation to uterosacral vault suspension with and without perioperative pelvic floor muscle training. Participants completed the AAS and SF-36 at baseline and 2 weeks and 6 months postoperatively. Internal reliability of the AAS was evaluated using Cronbach &agr;. Construct validity and responsiveness were examined in cross-sectional and longitudinal data using Pearson correlation coefficient and analysis of variance. The AAS is scored from zero to 100 (higher scores = better function). Results Mean (SD) baseline AAS score was 87 (17.3) (range, 25–100). Functional activity declined from baseline to 2 weeks postoperatively (mean change, −4.5; 95% confidence interval, −7.6 to −1.42) but improved above baseline at 6 months (mean change, +10.9; 95% confidence interval, 7.8–14.0). Internal reliability of the AAS was excellent (Cronbach &agr; = 0.93). Construct validity was demonstrated by a correlation of 0.59 to 0.60 between the AAS and SF-36 physical functioning scale (P < 0.0001) and lower correlations between the AAS and other SF-36 scales. Patients who improved in physical functioning based on the SF-36 between 2 weeks and 6 months postoperatively showed an effect size of 0.86 for change in the AAS over the same period. Conclusions The AAS is a valid, reliable, and responsive measure for evaluation of physical function in women after pelvic reconstructive surgery.