Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence.

OBJECTIVE: The eCoin (Valencia Technologies Corporation, Valencia, CA) is a battery-powered, nickel-sized and shaped neuromodulation device for the treatment of overactive bladder, and it is implanted in the lower leg in a short office or outpatient procedure under local anesthesia. A follow-on trial was conducted to evaluate the feasibility, safety, and efficacy of eCoin reimplantation. METHODS: This was a prospective, single-arm, open-label study, including 23 participants with refractory urgency urinary incontinence (UUI) who were previously participants in the eCoin clinical feasibility trial. This follow-on study was conducted at 7 sites in the United States and New Zealand. Participants were reimplanted with a new eCoin device and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 12 weeks and 24 weeks postactivation, were compared with baseline. RESULTS: Participants of the study were considered responders if they reported a ≥ 50% reduction from baseline in episodes of UUI on a 3-day voiding diary. At 12 weeks of treatment, 74% (95% confidence interval [CI], 52%-90%) of participants were considered responders. At 24 weeks of treatment, 82% (95% CI, 60%-95%) of participants were considered responders with 36% (95% CI, 20%-57%) of participants achieving complete continence. There were no device-related serious adverse events reported during the study. CONCLUSIONS: The reimplantation of eCoin was both safe and effective in treating UUI associated with overactive bladder syndrome. The demonstrated significant reduction or resolution of symptoms with no serious safety concern suggests that eCoin is a convenient and maintainable therapeutic device.

A Search for Novel Risk Factors for Obstetric Anal Sphincter Injury.

OBJECTIVE: The objective of this study is to evaluate factors associated with obstetric anal sphincter injury and identify modifiable risks. METHODS: A retrospective case-control study was performed in women who gave birth at our institution between May 2008 and December 2012. Patients who had a third- or fourth-degree lacerations were compared with those who did not. Parity, stretch marks, age, body mass index, tobacco use, fetal weight, operative delivery, labor, and second stage duration were compared between groups. Multivariate direct logistic regression was conducted on all patients who had complete data to calculate the adjusted odds ratio. RESULTS: We identified 299 patients with third- or fourth-degree lacerations and 8,459 patients without third- or fourth-degree lacerations during the time frame. Duration of second stage between 1 hour and 2 hours (P < 0.0001), duration of second stage greater than 2 hours (P < 0.0001), midline or unknown type episiotomy (P < 0.0001), mediolateral episiotomy (P < 0.0001), vacuum delivery (P < 0.0001), forceps delivery (P < 0.0001), fetal weight greater than 4,000 g (P < 0.0001), and antepartum stress urinary incontinence (P < 0.006) were associated with a significant increase in high-risk lacerations. This study did not find a statistically significant association between parity and these lacerations. CONCLUSIONS: We, as others, found that episiotomy and operative delivery were modifiable risks of obstetrical care. Furthermore, even a short second stage of labor (1-2 hours) was associated with significant risk of injury.

Twelve-month Durability of a Fully-implanted, Nickel-sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence: A Single-Arm, Prospective Study.

OBJECTIVES: To evaluate the safety and efficacy of the eCoin - a nickel-sized, primary battery-powered, neuromodulation device for the treatment of urgency urinary incontinence which is implanted in the lower leg in a 20-minute procedure under local anesthesia. A feasibility clinical trial was conducted and the results after 1 year of treatment with the eCoin are presented. METHODS: A total of 46 participants with refractory urgency urinary incontinence were included in this prospective, single-arm, open-label study. This study was conducted at 7 sites in the United States and New Zealand. Participants in this study were implanted with the eCoin in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 3, 6, and 12 months' post-activation, were compared to baseline values. RESULTS: Responders were defined as those who had a ≥50% reduction in reported episodes of urgency urinary incontinence. At 12 months', 65% of participants were considered responders with 26% of participants achieving complete continence. The median number of urgency urinary incontinence episodes per day decreased from 4.2 at baseline to 1.7 at 12 months'. Seventy percent of participants reported feeling "better", "much better", or "very much better" on the Likert 7-point maximum scale. One participant experienced a related serious adverse event. CONCLUSION: The eCoin is a safe and effective treatment for urgency urinary incontinence associated with overactive bladder syndrome, with significant reduction or complete resolution of symptoms and no significant safety concerns.

Outcomes of a single trigone-only vs. 20 trigone-sparing injections of OnabotulinumtoxinA for refractory overactive bladder (OAB).

PURPOSE: To compare the safety and durability of a single intravesical trigonal-only versus 20 trigone-sparing injections of OnabotulinumtoxinA (BTA) for refractory OAB. METHODS: A chart review of all idiopathic OAB patients treated with BTA from January 2016 to December 2018 was performed. Outcomes measures included: inter-injection interval, post-void residual (PVR), urinary tract infections (UTI), urinary retention requiring catheterization, and procedure time (min). Statistical analyses were performed using independent sample t-tests. RESULTS: Baseline characteristics were comparable for the two groups, data on 69 treatments (19 patients trigone-only) were compared to 105 treatments (26 patients trigone-sparing). There were no differences in the inter-injection intervals or rates of UTI. The trigone-only group exhibited a lower mean PVR (113 ml vs 160 ml, p < 0.02), lower proportion with PVR > 150 ml (23% vs. 39%, p < 0.03), lower rate of urinary retention (5.3% vs. 17.4%, p < 0.02), and shorter procedure time (4.3 min vs. 5.7 min, p < 0.01). There were no cases of vesico-ureteral reflux. CONCLUSION: While interpretation remains speculative, the results of this observational study suggest that a single trigone-only injection appears to be as safe and durable as multiple trigone-sparing injections but maybe quicker to perform and appears to have a lower impact on voiding function. Larger series and adequately powered prospective randomized clinical trials are warranted to validate the findings of this pilot study.

Predictive Value of Biomechanical Mapping for Pelvic Organ Prolapse Surgery.

OBJECTIVE: This study examined biomechanical changes in pelvic floor after urogynecological surgery. METHODS: This multisite clinical study was designed to explore changes in tissue elasticity, pelvic support, and certain functions (contractive strength, muscle relaxation speed, muscle motility) after pelvic organ prolapse (POP) surgery. A biomechanical mapping of the pelvic floor was performed before and 4 to 6 months after the surgery. The biomechanical data for 52 parameters were acquired by vaginal tactile imaging for manually applied deflection pressures to vaginal walls and pelvic muscle contractions. The two-sample t-test (P < 0.05) was used to test the null hypothesis that presurgery data in group 1 (positive parameter change after surgery) and presurgery data in group 2 (negative parameter change after surgery) belonged to the same distribution. RESULTS: A total of 78 subjects with 255 surgical procedures were analyzed across 5 participating clinical sites. All 52 t-tests for group 1 versus group 2 had P value in the range from 4.0 × 10-10 to 4.3 × 10-2 associating all of the 52 parameter changes after surgery with the presurgical conditions. The P value of before and after surgery correlation ranged from 3.7 × 10-18 to 1.6 × 10-2 for 50 of 52 tests, with Pearson correlation coefficient ranging from -0.79 to -0.27. Thus, vaginal tactile imaging parameters strongly correlated weak pelvic floor presurgery with the positive POP surgery outcome of improved biomechanical properties. CONCLUSIONS: Pelvic organ prolapse surgery, in general, improves the biomechanical conditions and integrity of the weak pelvic floor. The proposed biomechanical parameters can predict changes resulting from POP surgery.

Feasibility of a Fully Implanted, Nickel Sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence.

PURPOSE: We performed a clinical feasibility trial to evaluate the safety and efficacy of a fully implanted, primary battery powered, nickel sized and shaped neuromodulation device called the eCoin® for tibial nerve stimulation to treat refractory urgency urinary incontinence. MATERIALS AND METHODS: This prospective, single arm, open label study included 46 participants with refractory urgency urinary incontinence. It was performed at multiple sites in the United States and New Zealand. The device was implanted in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality of life instruments were collected 3 and 6 months after activation and compared to baseline values. RESULTS: The mean ± SD age of participants was 63.4 ± 11.5 years and 45 (98%) were female. Episodes of urgency urinary incontinence were reduced a relative median of 71% after 3 months of treatment (4.2 vs 1.7 daily episodes at 3 months, p = 0.001). A 50% or greater decrease in reported episodes of urgency urinary incontinence was observed in 32 of 46 participants (69.6%) at 3 months with more than 20% dry at 3 and 6 months. I-QOL (Incontinence Quality of Life) scores improved an average of 25.9 points and 33 of 46 patients (72%) indicated improvement in symptoms. A single serious adverse event secondary to wound care resolved with intravenous antibiotics. CONCLUSIONS: The implantable neuromodulation device was a safe and effective treatment of urgency urinary incontinence associated with overactive bladder syndrome with a significant reduction or resolution of symptoms and no significant safety concerns.

Quantitative Assessment and Interpretation of Vaginal Conditions.

INTRODUCTION: Few means exist to provide quantitative and reproducible assessment of vaginal conditions from biomechanical and functional standpoints. AIM: To develop a new approach for quantitative biomechanical characterization of the vagina. METHODS: Vaginal tactile imaging (VTI) allows biomechanical assessment of soft tissue and function along the entire length of the anterior, posterior, and lateral vaginal walls. This can be done at rest, with applied vaginal deformation, and with pelvic muscle contraction. RESULTS: Data were analyzed for 42 subjects with normal pelvic floor support from an observational case-controlled clinical study. The average age was 52 years (range = 26-90 years). We introduced 8 VTI parameters to characterize vaginal conditions: (i) maximum resistance force to insertion (newtons), (ii) insertion work (millijoules), (iii) maximum stress-to-strain ratio (elasticity; kilopascals per millimeter), (iv) maximum pressure at rest (kilopascals), (v) anterior-posterior force at rest (newtons), (vi) left-right force at rest (newtons), (vii) maximum pressure at muscle contraction (kilopascals), and (viii) muscle contraction force (newtons). We observed low to moderate correlation of these parameters with subject age and no correlation with subject weight. 6 of 8 parameters demonstrated a P value less than .05 for 2 subject subsamples divided by age (≤52 vs >52 years), which means 6 VTI parameters change with age. CONCLUSIONS: VTI allows biomechanical and functional characterization of the vaginal conditions that can be used for (i) understanding "normal" vaginal conditions, (ii) quantification of the deviation from normality, (iii) personalized treatment (radiofrequency, laser, or plastic surgery), and (iv) assessment of the applied treatment outcome. Egorov V, Murphy M, Lucente V, et al. Quantitative Assessment and Interpretation of Vaginal Conditions. Sex Med 2018;6:39-48.

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.

A preliminary evaluation of the TOPAS system for the treatment of fecal incontinence in women.

OBJECTIVES: The TOPAS AMS pelvic floor repair system is a self-fixating polypropylene mesh intended for use to reinforce soft tissues where weakness exists in the gynecological and gastroenterological anatomy. It is not available commercially in any country. This was a preliminary study conducted to obtain initial clinical experience with the TOPAS system for the treatment of fecal incontinence (FI) in women. METHODS: This was a prospective study conducted at 5 centers in the United States. Women with FI who failed 1 or more conservative therapies were candidates for the study. Fecal incontinence was assessed with a bowel diary, Cleveland Clinic incontinence scores (CCISs), and Fecal Incontinence Quality of Life (FIQOL) questionnaires, and patients were followed prospectively up to 24 months. Treatment success was defined as a reduction in number of FI episodes of 50% or more compared with baseline. RESULTS: A total of 29 women (mean age, 60.6 years) were implanted with the TOPAS system. Mean number of FI episodes per 14 days decreased from 6.9 at baseline to 3.5 at 24 months of follow-up, and the reduction was significant for the entire follow-up period compared with baseline (P < 0.001). A total of 55.6% of the subjects reported treatment success. The CCIS and FIQOL scores for all domains were significantly improved during the overall follow-up period compared with baseline (P < 0.001). The most common procedure and/or device-related adverse events were de novo urinary incontinence, including bladder spasms (n = 6), worsening FI (n = 2), and constipation (n = 2). No device-related erosions or extrusions were reported. CONCLUSIONS: Initial experience of the TOPAS system demonstrated a significant improvement in FI episodes, CCIS and FIQOL scores, and a benign safety profile. These results indicate that the TOPAS system has potential as a new therapeutic option for FI, but it needs to be confirmed in a larger study.

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.

Vaginal prolapse repair: suture repair versus mesh augmentation: a urogynecology perspective.

Based on the growing evidence within our literature, mesh is clearly needed for long-term success for the repair of anterior/apical defects. Clear credentialing and clinical privilege criteria policies are long overdue. Current data are rapidly growing, with level I studies completed that demonstrate that when transvaginal mesh-augmented repair is used in appropriately selected patients for the repair of pelvic organ prolapse, the procedure has a favorable risk/benefit ratio when compared with suture repair. This article highlights the evolving clinical-based experiences of the authors that are primarily grounded in reality-based medicine with the consideration and incorporation of evidence-based medicine.

Time to rethink: an evidence-based response from pelvic surgeons to the FDA Safety Communication: "UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse".

In July of 2011 the U.S. Food and Drug Administration (FDA) released a safety communication entitled "UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse." The stated purpose of this communication is to inform health care providers and patients that serious complications with placement of this mesh are not rare and that it is not clear that these repairs are more effective than nonmesh repair. The comments regarding efficacy are based on a systematic review of the scientific literature from 1996-2011 conducted by the FDA. Our review of the literature during this time yields some different conclusions regarding the safety and efficacy of mesh use in prolapse repair. It may be useful to consider this information prior to making recommendations regarding mesh use in prolapse surgery according to the recent UPDATE.

Prospective clinical assessment of the transvaginal mesh technique for treatment of pelvic organ prolapse-5-year results.

OBJECTIVES: : The objective of the study was to assess the effectiveness and complication rates for the transvaginal (TVM) technique in the treatment of pelvic organ prolapse (POP). METHODS: : Women with symptomatic POP (POP-Q stage II-IV) were invited to participate in this institutional review board-approved 5-year study at 3 US centers. All enrolled patients underwent prolapse repair surgery with GYNEMESH PS Prolene Nonabsorbable Soft Mesh using the TVM technique. Success was defined as International Continence Society (ICS) POP-Q stage I or less. The Prolapse-Specific Inventory and quality-of-life questionnaire was used as a subjective outcome measure. RESULTS: : Eighty-five women were included. Sixty-six patients were available for follow-up at 5 years. Overall anatomic success rates were 88% (90% confidence interval [CI], 80%-93%), 69% (90% CI, 59%-78%), and 67% (95% CI, 56%-76%) at 1, 3, and 5 years, respectively. Anatomic success rates in treated compartments were 89% (90% CI, 82%-94%), 76% (90% CI, 66%-84%), and 77% (90% CI, 67%-85%) at 1, 3, and 5 years, respectively. When defined as treated side leading edge above the hymen, success rates were 89% at 5 years. Five patients required reoperation for prolapse by 5 years. Statistically significant improvements in quality-of-life and Prolapse-Specific Inventory scores were sustained over 5 years. Mesh exposure was observed in 16 of 85 patients over the 5 years. Nine required partial mesh excision. There were 3 patients with some degree of dyspareunia, reported between 3 and 5 years, whereas in 8, preexisting dyspareunia resolved. There was 1 rectovaginal fistula reported and 2 reported ureteral injuries, one of which resulted in a ureteral-vaginal fistula; all resolved after repair. CONCLUSIONS: : Five-year results indicated that TVM provided a stable anatomic repair. Improvements in quality of life and associated improvements in specific prolapse symptoms were sustained over the 5-year period. Mesh exposure was the most common complication.

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.

Efficacy of Solifenacin on Symptom Bother and Health-Related Quality of Life in Patients With Acute, Early Chronic, and Late Chronic Overactive Bladder: Secondary Analysis of Data From the VOLT Study.

OBJECTIVES: : In many clinical trials of pharmacotherapy for overactive bladder (OAB), the duration of symptoms is reported as a baseline characteristic; none has investigated this as a prognostic variable. We evaluated the efficacy of solifenacin by patient-reported OAB duration. METHODS: : In this post hoc analysis, patients from a 12-week, open-label study of solifenacin were grouped into 3 OAB duration categories: 3 months to 1 year, 1 to 5 years, and more than 5 years. Changes from baseline to end point on the Patient Perception of Bladder Condition (PPBC), Overactive Bladder Questionnaire (OAB-q), and visual analog scale (VAS) are summarized for each duration cohort. In addition, analysis of covariance was used to compare baseline characteristics and treatment-related changes from baseline among the 3 duration cohorts. RESULTS: : After 12 weeks, all 3 duration cohorts showed numeric improvements in the PPBC, VAS, and OAB-q. Approximately 75% of patients in each group showed improvement on the PPBC. All 3 cohorts showed a 36- to 45-point improvement in the level of bother on the symptom-specific VAS. The magnitude of score improvements (14-31 points) on the OAB-q exceeded the minimally important within group difference of 10 points in all 3 groups. Although results from the analysis of covariance model indicated statistically significant differences between the 3 cohorts for some end points, these differences were numerically small and may not be clinically relevant. Tolerability was similar among the cohorts and compared with the safety population. The most frequently reported adverse events were dry mouth, constipation, headache, and blurred vision. CONCLUSIONS: : These findings showed that irrespective of OAB symptom duration, patients who received 12 weeks of solifenacin perceived meaningful improvements in symptom-specific bother, health-related quality of life, and their overall bladder condition.

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.

Quality of life and surgical satisfaction after vaginal reconstructive vs obliterative surgery for the treatment of advanced pelvic organ prolapse.

OBJECTIVE: We sought to compare quality of life and patient satisfaction after obliterative vs reconstructive surgery. STUDY DESIGN: A retrospective cohort study of women who met the following inclusion criteria: age 65 years or older, leading edge of prolapse 4 cm or greater beyond the hymen, and vaginal reconstructive or obliterative surgery. Preoperative responses to the Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) were collected retrospectively. We then mailed the same questionnaires, and the Surgical Satisfaction Questionnaire (SSQ-8), to these subjects postoperatively. RESULTS: Mode of surgery was evenly split (n = 45 per group) between the 90 patients meeting the inclusion criteria. Improvements from the preoperative to postoperative Incontinence Impact Questionnaire and Urogenital Distress Inventory were comparable as were postoperative Surgical Satisfaction Questionnaire scores. CONCLUSION: Improvements in condition-specific quality of life and postoperative patient satisfaction measures are comparable in women with prolapse who undergo either reconstructive or obliterative surgery.

Positive symptom improvement with laparoscopic uterosacral ligament repair for uterine or vaginal vault prolapse: interim results from an active multicenter trial.

STUDY OBJECTIVE: To evaluate the use of laparoscopic uterosacral ligament repair for long-term patient symptom improvement in patients with uterine prolapse or posthysterectomy vaginal vault prolapse and to evaluate how laparoscopic instrumentation kits facilitate procedure performance for the surgeon. DESIGN: Nonrandomized, prospective, multicenter case series (Canadian Task Force classification II-2). SETTING: Five clinical sites consisting of 4 community hospitals and 1 university medical center. PATIENTS: Seventy-two patients with stage II or worse uterine prolapse (58%, n = 42) or posthysterectomy vaginal vault prolapse (42%, n = 30). One patient with stage I vaginal vault prolapse was included in the group due to her significant symptoms. INTERVENTIONS: Laparoscopic uterosacral ligament repair was performed on all patients; round ligament truncation was also performed selectively on patients with uterine prolapse. Fifty-seven percent (41 patients) had concomitant pelvic procedures. MEASUREMENTS AND MAIN RESULTS: At 12-month follow-up, Pelvic Organ Prolapse Quantification (POP-Q) scores and patient self-reported symptom scores were significantly improved over baseline after laparoscopic repair of pelvic organ prolapse. Positive mean change in POP-Q score was 14.4 (p = .0003) for uterine prolapse repair and 9.28 (p = .017) for vaginal vault prolapse repair. Positive mean change in total symptom score was 20.36 (p <.0001) for uterine prolapse repair and 11.43 (p = .005) for vaginal vault prolapse repair. Surgeons reported a mean procedure time of 31.6 minutes for uterine prolapse repair and 21.7 minutes for vaginal vault prolapse repair. A mean rating of 7.5 was documented for ease of use for the uterine prolapse kit and 4.1 for the vaginal vault prolapse kit on a scale of 1 to 10. CONCLUSION: Laparoscopic uterosacral ligament repair improves symptoms and POP-Q scores over the long term in patients with uterine or vaginal vault prolapse. Laparoscopic instrumentation kits facilitate procedure performance for the surgeon with expedited surgery times.

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.