John R. Miklos

Prospective Randomized Controlled Trial of Extended-Release Oxybutynin Chloride and Tolterodine Tartrate in the Treatment of Overactive Bladder: Results of the OBJECT Study

OBJECTIVE To compare the efficacy and tolerability of extended-release oxybutynin chloride and tolterodine tartrate at 12 weeks in participants with overactive bladder. SUBJECTS AND METHODS The OBJECT (Overactive Bladder: Judging Effective Control and Treatment) study was a prospective, randomized, double-blind, parallel-group study conducted between March and October 2000 at 37 US study sites. Participants who had between 7 and 50 episodes of urge incontinence per week and 10 or more voids in 24 hours received extended-release oxybutynin, 10 mg/d, or tolterodine, 2 mg twice daily. The outcome measures were the number of episodes of urge incontinence, total incontinence, and micturition frequency at 12 weeks adjusted for baseline. RESULTS A total of 315 women and 63 men were randomized and treated, and 332 participants (276 women, 56 men) completed the study. At the end of the study, extended-release oxybutynin was significantly more effective than tolterodine in each of the main outcome measures: weekly urge incontinence (P=.03), total incontinence (P=.02), and micturition frequency episodes (P=.02) adjusted for baseline. Both drugs improved symptoms of overactive bladder significantly from baseline to the end of the study as assessed by the 3 main outcome measures (P<.001). Dry mouth, the most common adverse event, was reported by 28.1% and 33.2% of participants taking extended-release oxybutynin and tolterodine, respectively (P=.32). Rates of central nervous system and other adverse events were low and similar in both groups. CONCLUSIONS Extended-release oxybutynin was more effective than tolterodine as measured by end-of-study urge incontinence, total incontinence, and micturition frequency episodes. Both groups had similar rates of dry mouth and other adverse events.

Risk of Mesh Extrusion and Other Mesh-Related Complications After Laparoscopic Sacral Colpopexy with or without Concurrent Laparoscopic-Assisted Vaginal Hysterectomy: Experience of 402 Patients

STUDY OBJECTIVE To estimate the incidence of mesh-related complications including mesh erosion/extrusion rates in patients undergoing laparoscopic sacral colpopexy, with or without concurrent hysterectomy, using macroporous soft polypropylene mesh. DESIGN Historical cohort study (Canadian Task Force classification II-2). SETTING Private urogynecology clinic. PATIENTS A total of 446 consecutive patients with uterovaginal or vaginal vault prolapse underwent laparoscopic sacral colpopexy with use of macroporous soft polypropylene mesh from January 2003 through January 2007. In all, 402 consecutive patients met enrollment criteria. Two groups of patients were identified: (1) those receiving concurrent hysterectomy (n = 130); and (2) those with a history of hysterectomy (n = 272). INTERVENTIONS Patients were treated with laparoscopic sacral colpopexy with use of macroporous soft polypropylene mesh in conjunction with other laparoscopic and/or vaginal procedures. MEASUREMENTS AND MAIN RESULTS Data were collected in the form of chart reviews and patient questionnaires. Comparisons were made between groups 1 and 2. Patient demographics, history, mesh erosion/extrusion rates, and mesh-related complications were analyzed. Length of follow-up was 1 to 54 months with a median follow-up time of 12 months. No statistically significant differences existed between 2 groups in rates of mesh erosion/extrusion or other mesh-related complications. Overall vaginal mesh erosion/extrusion rate was 1.2% (95% CI 0.5%-2.7%) with an associated mesh revision rate of 1.2% (95% CI 0.5%-2.7%). Patients with concurrent hysterectomy had an erosion/extrusion rate of 2.3% (3/130) as compared with 0.7% (2/272) in patients with a history of hysterectomy, p = .18. No cases of mesh erosion through organs and tissues other than vaginal mucosa were observed. Cuff abscess occurred in 1 patient with concurrent hysterectomy, with an overall infection rate of 0.3% (95% CI 0.01%-1.2%). One more patient developed an inflammatory reaction to the mesh. Excision of exposed mesh was performed in all 5 patients with mesh extrusion. Vaginal approach to excision was uniformly used. Laparoscopic removal of the entire mesh took place in 4 patients with persistent pelvic pain, in 1 patient with cuff abscess, and in one patient with a questionable mesh reaction. An estimated 975 to 17 000 patients were required in each group to achieve power to detect a statistically significant difference in rate of mesh-related complications in this study. CONCLUSION Risk of mesh extrusion or other mesh-related complications after laparoscopic sacral colpopexy using soft macroporous Y-shaped polypropylene mesh is about 1% in our study. No significant increase in risk of mesh-related complications was observed in patients receiving concurrent hysterectomy when compared with patients who had a previous hysterectomy. The sample size of almost 2000 patients was needed to detect a statistically significant difference in rate of mesh-extrusion in this study.

Computed tomography comparison of bony pelvis dimensions between women with and without genital prolapse

OBJECTIVE To compare bony pelvis dimensions between white women with and without genital prolapse using computed tomography (CT) pelvimetry. METHODS Thirty-four multiparous white women with vaginal prolapse beyond the hymen and 34 matched white controls with no signs or symptoms of pelvic support defects underwent CT pelvimetry. The anteroposterior and transverse diameters of the pelvic inlet, the interspinous diameter of the midpelvis, and the intertuberous diameter of the pelvic outlet were measured. Post hoc power analysis showed that 22 women were needed in each group to detect a 10% difference in the pelvic dimensions between groups, with an alpha error of 1% and a beta error of 10%, resulting in a 90% power. RESULTS Mean (+/- standard deviation [SD]) age of the subjects was 63.4+/-8.3 years, compared with 62.9+/-7.8 years for controls. Mean parity of the subjects was 3.3+/-1.7, compared with 3.6+/-1.7 for controls. Mean (+/- SD) anteroposterior (12.5+/-1.3 versus 12.8+/-1.0 cm), interspinous (11.5+/-0.8 versus 11.2+/-0.9 cm), and intertuberous (10.0+/-1.0 versus 9.8+/-0.8 cm) diameters were not significantly different between study groups. Mean transverse diameter of the pelvic inlet was significantly greater in women with prolapse than those without prolapse (12.9+/-0.7 versus 12.4+/-0.6 cm, P = .006). CONCLUSION Women with advanced vaginal prolapse have larger transverse inlet diameters than do women with normal pelvic support.

Rectovaginal fistula repair using a porcine dermal graft.

BACKGROUND: Rectovaginal fistula repair is commonly performed through a vaginal route. In many cases, healthy tissue such as an autologous fat pad may be interposed between the suture lines and the vaginal epithelium to facilitate healing and prevent recurrence. We present a simple alternative to autologous flaps with the use of porcine dermal grafts in the repair of rectovaginal fistulae. CASES: Two patients are presented with rectovaginal fistulae. In both cases the patients were found to have insufficient native tissue to achieve an adequate traditional multilayered closure, and therefore an acellular collagen porcine dermal graft was used as an interposition graft between the rectum and the vaginal epithelium in the repair. CONCLUSION: Porcine dermal grafts may be a viable alternative to traditional autologous flaps or human dermal grafts for the repair of rectovaginal fistula

Vaginal repair of cystocele with anterior wall mesh via transobturator route: efficacy and complications with up to 3-year followup.

Study Objective. The objective of this study was to report on the safety and efficacy of cystocele repair with anterior wall mesh placed via a transobturator route (Perigee system, AMS, Minnetonka, MN). Design. Single center retrospective study. Setting. Single center hospital setting and Urogynecology practice in the United States. Patients. 77 women presenting with symptomatic anterior wall prolapse. Intervention. Repair of cystocele with an anterior wall Type I soft-polypropylene mesh placed via a transobturator approach. Concomitant procedures in other compartment were also completed as indicated. Measurements and Main Results. 77 women underwent the Perigee procedure at our institution over a 2-year period. The mesh was attached to the pelvic sidewalls at the level of the bladder neck and near the ischial spine apically with needles passed through the groins and obturator space. Mean follow-up was 18.2 months (range 3–36 months). Objective cure rate was 93%. Subjectively only two patients have had recurrent symptoms of prolapse, and only 1 of these has required repeat surgery for cystocele. Mesh exposure vaginally occurred in 5 patients (6.5%); however all were treated with estrogen and/or local excision of exposed mesh and had no further sequelae. There were no incidences of chronic pain, infection, or abscess, and no patient required complete mesh removal for infection, pain, or extrusion. Conclusion. In select patients with anterior wall prolapse, repair with mesh augmentation via the transobturator route is a safe and effective procedure with up to 3 years of follow-up.

Laparoscopic surgery for pelvic support defects.

Reconstructive pelvic surgery for the treatment of vaginal prolapse continues to evolve as surgeons continue their quest for definitive surgical cure. Though there are three primary routes of access to reconstructive pelvic surgery (abdominal, vaginal and laparoscopic) it is the laparoscopic approach that appears to be the least utilized. This is in part due to the great degree of technical difficulty associated with laparoscopic suturing. This paper reviews the general principles and functional anatomy associated with normal vaginal support as well as the laparoscopic surgical approach to pelvic floor support defects.

Osteomyelitis secondary to sacral colpopexy mesh erosion requiring laminectomy

BACKGROUND: Severe infectious morbidity associated with the use of synthetic mesh and abdominal sacral colpopexy is rare. Pelvic abscess, sinus tract formation, enterovaginal fistula, and osteomyelitis have been reported. CASE: This case involves a patient who presented with staphylococcal bacteremia and vaginal erosion of a sacral colpopexy synthetic mesh. Despite prolonged courses of intravenous antibiotics and complete removal of the mesh material, she developed osteomyelitis. Progressive neurologic symptoms required a decompression laminectomy to facilitate a complete recovery and resolution of symptoms. CONCLUSION: In the treatment of abdominal sacral colpopexy mesh erosion, we recommend maintaining a high index of suspicion for secondary infections.

The Sexual, Psychological, and Body Image Health of Women Undergoing Elective Vulvovaginal Plastic/Cosmetic Procedures: A Pilot Study

Vulvovaginal aesthetic (VVA) surgery has become increasingly popular, and there is anecdotal support for its enhancing effects on sexual functioning and self-concept. We conducted a prospective pilot study to evaluate the impact of VVA surgery on sexual response. A prospective cohort of women electing VVA cosmetic surgery completed questionnaires before VVA surgery (n = 33), after VVA surgery (n = 18), and again 6 to 9 months later (n = 12) using the Female Sexual Function Index (FSFI), the Brief Symptom Inventory (BSI), and the Yale-Brown Obsessive-Compulsive Scale for Body Dysmorphic Disorder (YBOCS-BDD). No signiÞ cant effect of VVA surgery was noted on Desire, Lubrication, Orgasm, Pain, or Total Score at either time point, but scores on Arousal and Satisfaction increased immediately after surgery, then fell back to baseline levels at follow-up. No signiÞ cant effect of VVA surgery was seen on psychological functioning at either time point. According to established cut-off scores for body dysmorphic disorder (BDD), 61.1% of participants met criteria for BDD at base-line; this proportion signiÞ cantly dropped to 11.1% after surgery, and to 8.3% at follow-up. Contrary to anecdotal claims, women in the present sample did not have symptoms of sexual dysfunction that may have motivated them to seek VVA surgery, nor was there any signiÞ cant effect of surgery on sexual response. It is important to note that a high pro-portion of women seeking VVA met criteria for BDD; this has implications for surgeons and consenting patients for these cosmetic genital procedures.

Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 18-month results from a prospective long-term study†‡

To evaluate 18‐month safety and durability of efficacy of nonsurgical transurethral collagen denaturation as treatment for stress urinary incontinence (SUI) in women.

Vesicovaginal Fistula Failing Multiple Surgical Attempts Salvaged Laparoscopically Without an Interposition Omental Flap

Failed vesicovaginal fistula repairs are often considered complicated and are thus relegated to an abdominal approach using an interposition omental flap. We report our successful laparoscopic approach without use of an omental flap in a patient with multiple recurrences of a vesicovaginal fistula.