Marlene M. Corton

Retropubic versus Transobturator Midurethral Slings for Stress Incontinence

BACKGROUND Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. METHODS We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points. RESULTS A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life. CONCLUSIONS The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.)

Behavioral Therapy to Enable Women with Urge Incontinence to Discontinue Drug Treatment: A Randomized Trial

BACKGROUND Women with urge urinary incontinence are commonly treated with antimuscarinic medications, but many discontinue therapy. OBJECTIVE To determine whether combining antimuscarinic drug therapy with supervised behavioral training, compared with drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to sustain these improvements after discontinuing drug therapy. DESIGN 2-stage, multicenter, randomized clinical trial conducted from July 2004 to January 2006. SETTING 9 university-affiliated outpatient clinics. PATIENTS 307 women with urge-predominant incontinence. INTERVENTION 10 weeks of open-label, extended-release tolterodine alone (n = 153) or combined with behavioral training (n = 154), followed by discontinuation of therapy and follow-up at 8 months. MEASUREMENTS The primary outcome, measured at 8 months, was no receipt of drugs or other therapy for urge incontinence and a 70% or greater reduction in frequency of incontinence episodes. Secondary outcomes were reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress and bother and health-related quality of life. Study staff who performed outcome evaluations, but not participants and interventionists, were blinded to group assignment. RESULTS 237 participants completed the trial. According to life-table estimates, the rate of successful discontinuation of therapy at 8 months was the same in the combination therapy and drug therapy alone groups (41% in both groups; difference, 0 percentage points [95% CI, -12 to 12 percentage points]). A higher proportion of participants who received combination therapy than drug therapy alone achieved a 70% or greater reduction in incontinence at 10 weeks (69% vs. 58%; difference, 11 percentage points [CI, -0.3 to 22.1 percentage points]). Combination therapy yielded better outcomes over time on the Urogenital Distress Inventory and the Overactive Bladder Questionnaire (both P <0.001) at both time points for patient satisfaction and perceived improvement but not health-related quality of life. Adverse events were uncommon (12 events in 6 participants [3 in each group]). LIMITATIONS Behavioral therapy components (daily bladder diary and recommendations for fluid management) in the group receiving drug therapy alone may have attenuated between-group differences. Assigned treatment was completed by 68% of participants, whereas 8-month outcome status was assessed on 77%. CONCLUSION The addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence. Combination therapy has a beneficial effect on patient satisfaction, perceived improvement, and reduction of other bladder symptoms.

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

Anatomy of Pelvic Floor Dysfunction

Normal physiologic function of the pelvic organs depends on the anatomic integrity and proper interaction among the pelvic structures, the pelvic floor support components, and the nervous system. Pelvic floor dysfunction includes urinary and anal incontinence; pelvic organ prolapse; and sexual, voiding, and defecatory dysfunction. Understanding the anatomy and proper interaction among the support components is essential to diagnose and treat pelvic floor dysfunction. The primary aim of this article is to provide an updated review of pelvic support anatomy with clinical correlations. In addition, surgical spaces of interest to the gynecologic surgeon and the course of the pelvic ureter are described. Several concepts reviewed in this article are derived and modified from a previous review of pelvic support anatomy.

Preventing L5-S1 discitis associated with sacrocolpopexy.

OBJECTIVE: To further characterize the anatomy of the fifth lumbar to first sacral (L5–S1) disc space and to provide anatomic landmarks that can be used to predict the locations of the disc, sacral promontory, and surrounding structures during sacrocolpopexy. METHODS: The lumbosacral anatomy was examined in 25 female cadavers and 100 computed tomography (CT) studies. Measurements were obtained using the midpoint of the sacral promontory as a reference. Data were analyzed using Pearson &khgr;2, unpaired Students t test, and analysis of covariance. RESULTS: The average height of the L5–S1 disc was 1.8±0.3 cm (range 1.3–2.8 cm) in cadavers and 1.4±0.4 cm (0.3–2.3) on CT (P<.001). The average angle of descent between the anterior surfaces of L5 and S1 was 60.5±9 degrees (39.5–80.5 degrees) in cadavers and 65.3±8 degrees (42.6–88.6 degrees) on CT (P=.016). The average shortest distance between the S1 foramina was 3.4±0.4 cm in cadavers and 3.0±0.4 cm on CT (P<.001). The average height of the first sacral vertebra (S1) was 3.0±0.2 cm in cadavers and 3.0±0.3 on CT (P=.269). CONCLUSION: In the supine position, the most prominent structure in the presacral space is the L5–S1 disc, which extends approximately 1.5 cm cephalad to the “true” sacral promontory. During sacrocolpopexy, awareness of a 60-degree average drop between the anterior surfaces of L5 and S1 vertebra should assist with intraoperative localization of the sacral promontory and avoidance of the L5–S1 disc. The first sacral nerve can be expected approximately 3 cm from the upper surface of the sacrum and 1.5 cm from the midline. LEVEL OF EVIDENCE: II

Vascular and ureteral anatomy relative to the midsacral promontory

OBJECTIVE The objective of the study was to further characterize the vascular and ureteral anatomy relative to the midsacral promontory, a landmark often used during sacrocolpopexy, and suggest strategies to avoid complications. STUDY DESIGN Distances between the right ureter, aortic bifurcation, and iliac vessels to the midsacral promontory were examined in 25 unembalmed female cadavers and 100 computed tomography (CT) studies. Data were analyzed using Pearson χ(2), unpaired Student t test, and analysis of covariance. RESULTS The average distance between the midsacral promontory and right ureter was 2.7 cm (range, 1.6-3.8 cm) in cadavers and 2.9 cm (range, 1.7-5.0 cm) on CT (P = .209). The closest cephalad vessel to the promontory was the left common iliac vein, the average distance being 2.7 cm (range, 0.95-4.75 cm) in cadavers and 3.0 cm (range, 1.0-6.1 cm) on CT (P = .289). The closest vessel to the right of the promontory was the internal iliac artery, with the average distance of 2.5 cm (range, 1.4-3.9 cm) in cadavers and 2.2 cm (range, 1.2-3.9 cm) on CT (P = .015). The average distance from the promontory to the aortic bifurcation was 5.3 cm (range, 2.8-9.7 cm) in cadavers and 6.6 cm (range, 3.1-10.1 cm) on CT (P < .001). The average distance from the aortic bifurcation to the inferior margin of the left common iliac vein was 2.3 cm (range, 1.2-3.9 cm) in cadavers and 3.5 cm (range, 1.7-5.6 cm) on CT (P < .001). CONCLUSION The right ureter, right common iliac artery, and left common iliac vein are found within 3 cm from the midsacral promontory. A thorough understanding of the extensive variability in vascular and ureteral anatomy relative to the midsacral promontory should help avoid serious intraoperative complications during sacrocolpopexy.

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

Anatomic relationships of the pudendal nerve branches

OBJECTIVE We sought to characterize the distribution of the pudendal nerve branches and to correlate findings with injury risk related to common midurethral sling procedures. STUDY DESIGN Dissections were performed in 18 female cadavers. Biopsies were obtained to confirm gross findings by histology. RESULTS In all dissections, most of the clitoral and perineal nerves coursed caudal to the ventral portion of the perineal membrane. The inferior rectal nerve did not enter the pudendal canal in 44% (n = 8) of specimens. Nerve tissue was confirmed histologically in tissue sampled. CONCLUSION The clitoral and perineal branches of the pudendal nerve should be at low risk of direct nerve injury during midurethral slings and similar procedures as they course caudal to the ventral portion of the perineal membrane. The inferior rectal nerve might be at risk of injury during procedures that involve passage of needles through the ischioanal fossa.

Multiple vaginal wall cysts: diagnosis and surgical management.

BACKGROUND: Simple cysts of the female genital tract may become symptomatic and require surgical removal. CASE: A 20-year-old woman had complaints of a vaginal bulge, pelvic pressure, dyspareunia, and stress urinary incontinence. Two cystic masses were seen in the vagina. A magnetic resonance imaging scan revealed 2 additional larger cysts. Urodynamic evaluation was significant for stress incontinence at 200 mL and a Valsalva leak-point pressure of 51 cm H20. The 2 smaller cysts were removed intact through a superficial incision. The larger cysts were intentionally ruptured and dissected out. Histologic examination revealed a low cuboidal or a ciliated columnar epithelium that stained positive with mucicarmine, consistent with müllerian origin. One year after surgical excision, the patient remained symptom free with no urinary incontinence and no recurrence of the cysts. CONCLUSION: Magnetic resonance imaging was useful in delineating the course and anatomic arrangement of the vaginal cysts, but more importantly, identified another cyst that was not readily apparent at physical examination.