Vincent Lucente

Vaginal versus abdominal reconstructive surgery for the treatment of pelvic support defects: a prospective randomized study with long-term outcome evaluation.

OBJECTIVES Our purpose was to determine whether a vaginal or abdominal approach is more effective in correcting uterovaginal prolapse. STUDY DESIGN Eighty-eight women with cervical prolapse to or beyond the hymen or with vaginal vault inversion > 50% of its length and anterior vaginal wall descent to or beyond the hymen were randomized to a vaginal versus abdominal surgical approach. Forty-eight women underwent a vaginal approach with bilateral sacrospinous vault suspension and paravaginal repair, and 40 women underwent an abdominal approach with colposacral suspension and paravaginal repair. Ancillary procedures were performed as indicated. Detailed pelvic examination was performed postoperatively by the nonsurgeon coauthor yearly up to 5 years. The women were examined while standing during maximum strain. Surgery was classified as optimally effective if the woman remained asymptomatic, the vaginal apex was supported above the levator plate, and no protrusion of any vaginal tissue beyond the hymen occurred. Surgical effectiveness was considered unsatisfactory if the woman was symptomatic, the apex descended > 50% of its length, or the vaginal wall protruded beyond the hymen. RESULTS Eighty women (vaginal 42, abdominal 38) were available for evaluation at 1 to 5.5 years (mean 2.5 years). The groups were similar in age, weight, parity, and estrogen status, and 56% had undergone prior pelvic surgery. There was no significant difference between the groups in morbidity, complications, hemoglobin change, dyspareunia, pain, or hospital stay. The vaginal group had longer catheter use, more urinary tract infections, more incontinence, decreased operative time, and lower hospital charge. Surgical effectiveness was optimal in 29% of the vaginal group and 58% of the abdominal group and was unsatisfactory leading to reoperation in 33% of the vaginal group and 16% of the abdominal group. The reoperations included procedures for recurrent incontinence in 12% of the vaginal and 2% of the abdominal groups. The relative risk of optimal effectiveness by the abdominal route is 2.03 (95% confidence interval 1.22 to 9.83), and the relative risk of unsatisfactory outcome using the vaginal route is 2.11 (95% confidence interval 0.90 to 4.94). CONCLUSIONS Reconstructive pelvic surgery for correction of significant pelvic support defects was more effective with an abdominal approach.

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 1 in the treated compartment) was 86.6% at follow-up. Three patients experienced recurrent apical prolapse. An additional 15 patients presented with >/= 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.

Oxybutynin transdermal system improves the quality of life in adults with overactive bladder: a multicentre, community-based, randomized study

To assess health‐related quality‐of‐life (HRQoL) and safety with the oxybutynin transdermal system (OXY‐TDS) (Oxytrol®, Watson Pharma, Corona, CA, USA) in the Multicentre Assessment of Transdermal Therapy in Overactive Bladder With Oxybutynin (MATRIX) study, as HRQoL measurements are increasingly important in evaluating pharmacotherapy for overactive bladder (OAB).

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.

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.

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.

Quantifying vaginal tissue elasticity under normal and prolapse conditions by tactile imaging.

Introduction and hypothesisVaginal tactile imaging (VTI) is based on principles similar to those of manual palpation. The objective of this study is to assess the clinical suitability of new approach for imaging and tissue elasticity quantification under normal and prolapse conditions.MethodsThe study subjects included 31 women with normal and prolapse conditions. The tissue elasticity (Young’s modulus) was calculated from spatial gradients in the resulting 3-D tactile images.ResultsAverage values for tissue elasticity for the anterior and posterior compartments for normal conditions were 7.4 ± 4.3 kPa and 6.2 ± 3.1 kPa respectively. For Stage III prolapse the average values for tissue elasticity for anterior and posterior compartments were 1.8 ± 0.7 kPa and 1.8 ± 0.5 kPa respectively.ConclusionsVTI may serve as a means for 3-D imaging of the vagina and a quantitative assessment of vaginal tissue elasticity, providing important information for furthering our understanding of pelvic organ prolapse and surgical treatment.

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.