A posterior anal sling for fecal incontinence: results of a 152-patient prospective multicenter study.

BACKGROUND: The transobturator posterior anal sling (TOPAS) system is a posterior anal sling that is a minimally invasive, self-fixating polypropylene mesh intended to treat fecal incontinence (FI) in women who have failed conservative therapy. OBJECTIVE: We are reporting 1-year outcome in a prospective, multicenter study under investigational device exemption, evaluating this new treatment modality. STUDY DESIGN: A total of 152 women were implanted with the TOPAS system at 14 centers in the United States. FI was assessed preoperatively and at the 12-month follow up with a 14-day bowel diary, Cleveland Clinic Incontinence Scores, and FI Quality of Life questionnaires. Treatment success was defined as reduction in number of FI episodes of ≥50% compared to baseline. Missing bowel diary data were considered treatment failures. The Wilcoxon signed rank test was used to compare changes observed at 12 months vs baseline. RESULTS: Mean age was 59.6 years old (SD 9.7). The mean duration of FI was 110 mo (range 8-712) months. Mean length of the implant procedure was 33.4 (SD 11.6) minutes. Mean EBL was 12.9 (SD 10.5) mL. Average follow-up was 24.9 months. At 12 months, 69.1% of patients met the criteria for treatment success, and 19% of subjects reported complete continence. FI episodes/wk decreased from a median of 9.0 (range 2-40) at baseline to 2.5 (range 0-40) (P < .001). FI days decreased from a median of 5.0 (range 1.5-7) at baseline to 2.0 (range 0-7) (P < .001) over a 7-day period. FI associated with urgency decreased from a median at baseline of 2.0 (range 0-26) to 0 (range 0-14.5) (P < .001). The mean Cleveland Clinic Incontinence Scores decreased from 13.9 at baseline to 9.6 at 12 months (P < .001). FI Quality of Life scores for all 4 domains improved significantly from baseline to 12 months (P < .001). A total of 66 subjects experienced 104 procedure- and/or device-related adverse events (AEs). Most AEs were short in duration and 97% were managed without therapy or with nonsurgical interventions. No treatment-related deaths, erosions, extrusions, or device revisions were reported. The most common AE categories were pelvic pain (n = 47) and infection (n = 26). Those subjects experiencing pelvic pain had a mean pain score (0-10 scale, 0 = no pain) during the 12-month follow-up of 1.2 (SD 2.4). CONCLUSION: The TOPAS system provides significant improvements in FI symptoms and quality of life with an acceptable AE profile and may therefore be a viable minimally invasive treatment option for FI in women.

One-year functional and anatomic outcomes of robotic sacrocolpopexy versus vaginal extraperitoneal colpopexy with mesh.

OBJECTIVES: This study aimed to evaluate and compare 1-year anatomic and functional outcomes in patients undergoing transvaginal versus transabdominal repair of pelvic organ prolapse (POP) with synthetic mesh reinforcement. METHODS: We conducted a retrospective, matched cohort study of patients undergoing robotic-assisted laparoscopic sacrocolpopexy (RALSC) and vaginal extraperitoneal colpopexy (VEC) with synthetic mesh from December 2008 to March 2011. We compared the preoperative to postoperative changes in anatomic, quality of life, and functional outcomes between groups after 1 year of follow-up. One-year surgical satisfaction was also assessed. RESULTS: Thirty-eight RALSC patients met the inclusion criteria and were matched by age and month of surgery to 38 VEC patients. Of those, 31 RALSC and 30 VEC patients (80%) had complete 1-year data. Preoperative to postoperative outcomes were similar in both groups with similar improvement seen in anatomic Pelvic Organ Prolapse Quantification measures as well as functional questionnaire scores. Both groups demonstrated high surgical satisfaction. Symptom distress inventory scales revealed 84% and 90% resolution of symptomatic "bulge" in RALSC and VEC patients, respectively (P = 0.74). The RALSC group had a significantly greater operative time by approximately 96 minutes and greater use of general anesthesia (P = <0.001). No difference was noted in blood loss, hospital days, or return to normal voiding between groups. CONCLUSIONS: Transabdominal and transvaginal techniques of colpopexy using synthetic mesh implants for POP have been shown in this retrospective cohort study to improve quality of life and anatomic measures with similar outcomes. Robotic-assisted laparoscopic sacrocolpopexy results in a greater use of general anesthesia and longer operative time.

Laparoscopic sacrocolpopexy versus transvaginal mesh for recurrent pelvic organ prolapse.

Both expert surgeons agree with the following: (1) Surgical mesh, whether placed laparoscopically or transvaginally, is indicated for pelvic floor reconstruction in cases involving recurrent advanced pelvic organ prolapse. (2) Procedural expertise and experience gained from performing a high volume of cases is fundamentally necessary. Knowledge of outcomes and complications from an individual surgeon's audit of cases is also needed when discussing the risks and benefits of procedures and alternatives. Yet controversy still exists on how best to teach new surgical techniques and optimal ways to efficiently track outcomes, including subjective and objective cure of prolapse as well as perioperative complications. A mesh registry will be useful in providing data needed for surgeons. Cost factors are also a consideration since laparoscopic and especially robotic surgical mesh procedures are generally more costly than transvaginal mesh kits when operative time, extra instrumentation and length of stay are included. Long-term outcomes, particularly for transvaginal mesh procedures, are lacking. In conclusion, all surgery poses risks; however, patients should be made aware of the pros and cons of various routes of surgery as well as the potential risks and benefits of using mesh. Surgeons should provide patients with honest information about their own experience implanting mesh and also their experience dealing with mesh-related complications.

Ajust single incision transobturator sling procedure for stress urinary incontinence: results after 1-year follow-up.

INTRODUCTION AND HYPOTHESIS: Data on the Ajust, a new single-incision sling procedure for female stress urinary incontinence (SUI) management, remain scarce and limited to a 1-year follow-up. Our goal was to assess the efficacy of this procedure after a 1-year follow-up. METHODS: This prospective evaluation involved 95 consecutive patients implanted with Ajust at a single centre. All patients had SUI on urodynamics due to urethral hypermobility, 33 % had preoperative overactive bladder (OAB) symptoms and none had detrusor overactivity. Ninety-two patients were treated on an outpatient basis, and 3 patients had general anaesthesia. Postoperative assessment was conducted at 1, 6, 12 months, and yearly thereafter. The main outcome measure was pad usage. Secondary parameters were self-reported SUI episodes, OAB symptoms, data of clinical examination, satisfaction using the Patient Global Impression of Improvement (PGI-I) scale, postoperative pain, and adverse events. RESULTS: After a mean follow-up of 21 ± 6 months (12-32), 76 out of 95 patients used no pads or one dry security pad, showing a success rate of 80 %. Seventy-nine out of 95 patients had no more SUI-related leakage. Only 6 patients experienced late recurrence of SUI after 6 months' follow-up. Perioperative complications included 1 case of vaginal hematoma, 1 case of acute urinary retention, 2 cases of urinary tract infection, all managed conservatively. Half of the patients had no pain after day 1, free of medications. Late complications were vaginal erosion in 1 case, and pain during exertion in 2 cases. CONCLUSIONS: The Ajust single incision transobturator sling is a safe and effective procedure, with durable results after 1 year.

Efficacy and safety of oxybutynin chloride topical gel for women with overactive bladder syndrome.

OBJECTIVE: This subgroup analysis of a phase-3 study evaluated the efficacy and safety of oxybutynin chloride topical gel (OTG) in women with overactive bladder syndrome (OAB). STUDY DESIGN: Women (n = 704) with urgency-predominant urinary incontinence received OTG or placebo for 12 weeks. The primary endpoint was change from baseline to last observation in number of daily incontinence episodes. Treatments were compared with the use of analysis of covariance. RESULTS: OTG significantly reduced the number (mean ± standard deviation) of daily incontinence episodes (OTG, -3.0 ± 2.8 episodes; placebo, -2.5 ± 3.0 episodes; P < .0001), reduced urinary frequency (P = .0013), increased voided volume (P = .0006), and improved select health-related quality-of-life domains (P ≤ .0161) vs placebo. Dry mouth was the only drug-related adverse event significantly more common with OTG (7.4%) than with placebo (2.8%; P = .0062). CONCLUSION: OTG was well tolerated and provided significant improvement in urinary symptoms and health-related quality of life in women with OAB.

Development of oxybutynin chloride topical gel for overactive bladder.

Overactive bladder (OAB) is an age-related syndrome often associated with urinary incontinence. Symptoms of OAB, such as urgency, frequency, and nocturia, can be treated effectively with inhibitors of muscarinic acetylcholine receptors. Antimuscarinic agents promote relaxation of the detrusor muscle and may modulate afferent neuronal signals involved in the regulation of the micturition reflex. Despite the availability of an increasing number of oral antimuscarinic agents, treatment persistence among patients with OAB generally appears to be low. This may be attributed, at least in part, to the common occurrence of anticholinergic adverse effects, such as dry mouth, constipation, and dizziness. Oxybutynin is a well-established antimuscarinic agent that is available in a variety of formulations. Transdermal formulations have been developed to avoid the first-pass hepatic and gastrointestinal drug metabolism responsible for the anticholinergic adverse effects often observed with oral delivery of oxybutynin. Oxybutynin chloride topical gel (OTG) is a formulation of oxybutynin that was approved by the US Food and Drug Administration in January 2009. OTG was the result of a systematic evidence-based effort to develop a formulation that preserves the efficacy of oral oxybutynin formulations while eliminating most of their anticholinergic adverse effects. Additional emphasis was put on creating a transdermal formulation with minimal potential for application-site skin reactions. The formulation and pharmacokinetic properties of OTG are reviewed in the context of recently published efficacy and tolerability data from a large multicenter, placebo-controlled Phase III study.

Vaginal hysterectomy at the time of transvaginal mesh placement.

INTRODUCTION: : Previous investigations have shown an increased risk of mesh erosion when concomitant vaginal hysterectomy is performed at the time of transvaginal reconstruction with mesh. We hypothesize that vaginal hysterectomy can be performed without a high risk of erosion. METHODS: : This is a retrospective, repeated-measures study of women with uterovaginal prolapse who underwent vaginal hysterectomy and pelvic reconstruction with a transvaginal mesh technique using the Prolift system. Mesh was never placed behind the cuff closure and "T" incisions were not used. We compared preoperative quality-of-life and Pelvic Organ Prolapse Quantification values to postoperative values. RESULTS: : Forty women met the study criteria. The median length of follow-up was 12 months (range 4-43 months). Thirty-two (80%) of the women had at least 1 year of follow-up. Significant improvements were found in all quality-of-life measures. Except for genital hiatus and perineal body length, a significant change was seen in all Pelvic Organ Prolapse Quantification measures. The greatest mean change found was for point "C" going from +2.4 to -6.8 cm (P < 0.001). There was 1 (2.5%) mesh erosion. CONCLUSIONS: : When incisions for mesh placement are kept separate from the vaginal cuff, transvaginal mesh reconstruction can be safely performed at the time of hysterectomy.

One-year anatomic and quality-of-life outcomes after the Prolift procedure for treatment of posthysterectomy prolapse.

OBJECTIVE: To evaluate anatomic and quality-of-life outcomes at 1-year or greater after treatment of posthysterectomy prolapse with the Prolift procedure. STUDY DESIGN: A retrospective repeated measures study comparing preoperative and 1-year or greater postoperative outcomes, including Pelvic Organ Prolapse Quantification measurements, Urogenital Distress Inventory, and Incontinence Impact Questionnaire scores. RESULTS: Ninety-seven patients were included, with a median follow-up of 19.0 months. Forty-six anterior, 28 posterior, and 23 total Prolift procedures were performed. At 1 year, Pelvic Organ Prolapse Quantification values were significantly improved, as were scores for Incontinence Impact Questionnaire, the Urogenital Distress Inventory, and its subscales, with the greatest improvement seen in the obstructive/discomfort subscale. Anatomical success (/= stage 2 in the untreated vaginal compartment. CONCLUSION: Significant anatomic and quality-of-life improvements among patients undergoing the Prolift procedure for posthysterectomy prolapse were demonstrated.

New minimally invasive slings: TVT Secur.

Single-incision slings are now approved by the US Food and Drug Administration. TVT Secur (Ethicon, Somerville, NJ), the first mini sling available for use, offers a minimally invasive approach to the surgical treatment of stress incontinence, with its greatest benefit being reduced patient discomfort in the immediate postoperative period. Although little data are available regarding the safety and efficacy of this new generation of slings, TVT Secur appears to be relatively safe. Long-term efficacy has not yet been determined, but short-term efficacy rates seem to compare with traditional midurethral mesh slings. Long-term follow-up is warranted and comparative studies are needed to determine its true efficacy.

Incontinence-related quality of life and sexual function following the tension-free vaginal tape versus the "inside-out" tension-free vaginal tape obturator.

The objective of this cohort study was to compare morbidity, quality of life, and sexual function in stress-incontinent women treated with tension-free vaginal tape (TVT) versus tension-free vaginal tape obturator (TVT-O) in a group of 329. Preoperative scores of the Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) were compared to those from a mailed, postoperative questionnaire. The Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-12) and three additional questions were also included in the mailing. Of the initial 329 patients, 239 (73%) completed the questionnaire with a mean follow-up of 14.7 months. Complications, return to normal voiding, and operative time were less in the TVT-O group. Postoperative PISQ-12 scores and improvements in the UDI-6 and IIQ-7 were comparable between groups. The TVT-O procedure appears to be as effective in improving incontinence-related quality of life as the TVT. No differences in sexual function were demonstrated between groups.

Laparoscopic transabdominal transvesical vesicovaginal fistula repair.

BACKGROUND AND PURPOSE: Transabdominal transvesical repair has been the standard treatment for difficult vesicovaginal fistulae. We describe a laparoscopic transvesical technique that minimizes operative morbidity while adhering to the principles of transabdominal repair as described by O'Conner. TECHNIQUE: The patient is placed in the lithotomy position using Allen stirrups, and bilateral 5F open-ended ureteral catheters are placed cystoscopically. Using four laparoscopic ports, the prevesical space is accessed. The bladder is bivalved down to the fistula, and stay sutures are placed at the bladder edges for exposure. The fistulous tract and adjacent fibrotic tissue are excised, and the bladder and vagina are closed separately with single layers of full-thickness interrupted 2-0 Vicryl sutures. An omental flap is interposed between suture lines in the bladder and vagina. The ureteral catheters are sequentially removed on the first and second postoperative days. A gravity cystogram is performed 3 weeks postoperatively; if it is normal, the urethral catheter is removed. RESULTS: This procedure has been performed on two consecutive patients who had failed prior Latzko repairs. Both patients were discharged 2 days postoperatively without complications. At a follow-up of 41 months in the first patient and 39 months in the second, no fistula recurrence has been seen. CONCLUSIONS: Laparoscopic transvesical vesicovaginal fistula repair appears to be a safe and effective procedure that adheres to the principles of a transabdominal transvesical fistula repair while decreasing morbidity and improving cosmesis. Continued follow-up is required to determine its long-term efficacy compared with the accepted open transabdominal and transvaginal approaches.