Michael D. Vardy

Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT – a double-blind, placebo-controlled trial

Aim:  The aim of this study was to evaluate the efficacy of solifenacin on symptom bother using the Overactive Bladder Questionnaire (OAB‐q).

Long-term quality of life and pelvic floor dysfunction after bariatric surgery

OBJECTIVE To evaluate effects of bariatric surgery on pelvic floor mediated quality of life in morbidly obese women. STUDY DESIGN Prospective cohort study of 44 women undergoing bariatric surgery. RESULTS Thirty-six women gave data at baseline and at mean follow-up of 3.15 years following bariatric surgery. Although urinary impact questionnaire scores improved (-34.92, P = .0020), colorectal-anal impact questionnaire and pelvic organ prolapse impact questionnaire scores did not improve despite significant weight loss. Baseline female sexual function index scores were low (17.70 ± 8.38) and did not improve with weight loss (16.91 ± 9.75, P = .5832). Pelvic organ prolapse/urinary incontinence sexual questionnaire scores did improve (35.78 ± 6.06 preoperatively vs 38.22 ± 6.03 postoperatively, P = .0193). CONCLUSION Bariatric surgery is associated with significant improvement in the impact of urinary incontinence on quality of life. Sexual function was poor, and improved only on the pelvic organ prolapse/urinary incontinence sexual questionnaire that evaluated urinary incontinence.

Use of pelvic organ prolapse staging systems in published articles of selected specialized journals

Introduction and hypothesisA standardized system for reporting pelvic organ prolapse is important for clinical communication, patient follow-up, and meaningful comparisons between studies. In 1996, the description of the Pelvic Organ Prolapse Quantification system (POPQ) was published. We hypothesized that its use in published articles of specialized journals would increase over time.MethodsArticles from eight journals in 2004 and 2007 were included if any attempt to grade prolapse was mentioned. Reviews, editorials, and abstracts were excluded.ResultsUse of POPQ increased from 64.9% to 82.1% (p = 0.01) while other systems decreased. POPQ was used more frequently in the US than other countries. Urologists used POPQ less and Baden–Walker more frequently than other specialists.ConclusionsUse of POPQ has increased in the period studied. This trend was observed in all the subgroups analyzed, showing that POPQ is being adopted as the universal language of prolapse in the published literature.

Effect of hormone replacement and selective estrogen receptor modulators (SERMs) on the biomechanics and biochemistry of pelvic support ligaments in the cynomolgus monkey (Macaca fascicularis)

OBJECTIVE To evaluate the effect of selective estrogen receptor modulators and ethinyl estradiol on the biomechanical and biochemical properties of the uterosacral and round ligaments in the monkey model of menopause. STUDY DESIGN A randomized, double-blind, placebo-controlled study on 11 female macaque monkeys. Ovariectomized monkeys received 12 weeks of placebo, raloxifene, tamoxifen, or ethinyl estradiol. Biomechanical step-strain testing and real-time polymerase chain reaction was performed on the uterosacral and round ligaments. RESULTS Tamoxifen and raloxifene uterosacrals expressed differing collagen I/III receptor density ratios, but both selective estrogen receptor modulators showed decreased tensile stiffness compared to ethinyl estradiol and controls. CONCLUSION These findings support a possible effect of selective estrogen receptor modulators on biomechanical and biochemical properties of uterosacrals. This may play a role in pelvic organ prolapse.

Patient Preferences for Abdominal Incisions Used for Pelvic Organ Prolapse Surgery.

Objectives Approaches for performing sacrocolpopexy (laparotomy, laparoscopy, and robotically assisted) differ with regard to length of surgery, postoperative pain, and cosmetic appearance of skin incisions. The aim of our study is to better understand what factors influence patient preferences for surgical approach. Methods A cross-sectional study was performed using a survey. Females 18 years or older presenting to gynecologic offices were asked to complete a survey that included photographs of patient incisions 6 weeks postoperatively along with a schematic representation of each incision type (laparotomy with low transverse incision, traditional laparoscopy, and robotically assisted). Patients were first asked to rank each incision based on cosmetic appearance only. They were next given varying clinical scenarios associated with each surgical approach and asked if their preference of incision changed. A sample size of 90 subjects was needed in order to detect a 30% difference in incision preference based on appearance with an &agr; of 0.05 and 80% power. Results One hundred fifty patients completed the survey. Based on cosmetic appearance alone, 70% chose laparoscopic surgery, 23% chose open, and 7% chose the robotic approach (P < 0.0001). The majority of the subjects would not change their incision preference of laparoscopy based on differing scenarios of postoperative pain (62.6%), length of surgery (65.3%), and length of hospital stay (73.6%). When asked to rank factors important in decision making, complication rate (53.9%) and surgeon experience with the procedure (32.8%) were ranked as most important. Conclusions Based on cosmetic appearance, patients prefer the laparoscopic approach for abdominal sacrocolpopexy for pelvic organ prolapse surgery. However, complication rates and surgeon experience with the procedure are important factors in the patient’s decision making.

Comparison of Human to Macaque Uterosacral-Cardinal Ligament Complex and Its Relationship to Pelvic Organ Prolapse

The uterosacral–cardinal ligament complex is thought to be the critical structure responsible for uterine and apical vaginal support. It is ill defined and can be difficult to dissect in the cadaver lab and in the operating room. Even less information is available on the analogous structures in the monkey model. We present this report to bring together what little is known to aid in studying this model and pelvic organ prolapse (POP), and to point out the need for critical assessment of this hormone-responsive tissue in the process of drug development. Competing Interests: This article was sponsored by Covance Inc. and Schering-Plough. The authors did not declare any other competing interests.

Efficacy of Solifenacin on Overactive Bladder Symptoms, Symptom Bother, and Other Patient-Reported Outcomes in Subjects With or Without Incontinence: A Post Hoc Analysis of Data From VIBRANT.

Objective: To evaluate the efficacy of solifenacin versus placebo by baseline continence status using post hoc analysis. Methods: Patients with overactive bladder (OAB) were randomized to solifenacin or placebo for 12 weeks; patient-reported outcome (PRO) measures and bladder diaries were completed at prespecified time points. VESIcare Investigation of Bother and Quality of Life in Subjects with OAB (VIBRANT) was not designed to show treatment differences within continence status subgroups. Results: In the full analysis set (n = 750), 73% of patients were incontinent (n = 545) at baseline. After 12 weeks, incontinent patients receiving solifenacin showed significant improvements versus placebo on PRO measures and most diary-based end points; continent patients (n = 205) showed smaller but similar treatment-related changes. Tolerability was similar in both subgroups and by treatment; most frequent adverse events were dry mouth and constipation. Conclusions: In the VIBRANT study, solifenacin significantly improved OAB symptom bother, health-related quality of life, and most symptoms versus placebo in incontinent patients. Continent patients showed smaller but similar trends. Solifenacin was well tolerated in both subgroups.

Sacral Neuromodulator InterStim Surgical Site Infection: Two Case Reports.

Objective: The surgical site infection rate of sacral neuromodulator placement for the treatment of refractory urge urinary incontinence is reported to be between 5% and 7.9%. Our objective was to report the investigation process of these infections and a possible source for their occurrence. Methods: We performed infection control surveillance of two patients that underwent sacral neuromodulator placement on the same date, in the same operating room, and by the same staff who developed similar sacral cellulitis postoperatively. Results: The investigation revealed Staphylococcus aureus infections with a common antibiogram in both patients. Nasal cultures of all personnel involved in their care, showed Staphylococcus aureus with the same antibiogram only in a Medtronic representative who had manipulated the InterStim settings. Genetic analysis showed this to be an identical strain in one patient infection. Conclusions: The postoperative manipulation of device settings may be a source of surgical site infection, and infection control practices including strict hand washing, gloves, gown and mask may be warranted.