Cindy L. Amundsen

A Midurethral Sling to Reduce Incontinence after Vaginal Prolapse Repair

BACKGROUND Women without stress urinary incontinence undergoing vaginal surgery for pelvic-organ prolapse are at risk for postoperative urinary incontinence. A midurethral sling may be placed at the time of prolapse repair to reduce this risk. METHODS We performed a multicenter trial involving women without symptoms of stress incontinence and with anterior prolapse (of stage 2 or higher on a Pelvic Organ Prolapse Quantification system examination) who were planning to undergo vaginal prolapse surgery. Women were randomly assigned to receive either a midurethral sling or sham incisions during surgery. One primary end point was urinary incontinence or treatment for this condition at 3 months. The second primary end point was the presence of incontinence at 12 months, allowing for subsequent treatment for incontinence. RESULTS Of the 337 women who underwent randomization, 327 (97%) completed follow-up at 1 year. At 3 months, the rate of urinary incontinence (or treatment) was 23.6% in the sling group and 49.4% in the sham group (P<0.001). At 12 months, urinary incontinence (allowing for subsequent treatment of incontinence) was present in 27.3% and 43.0% of patients in the sling and sham groups, respectively (P=0.002). The number needed to treat with a sling to prevent one case of urinary incontinence at 12 months was 6.3. The rate of bladder perforation was higher in the sling group than in the sham group (6.7% vs. 0%), as were rates of urinary tract infection (31.0% vs. 18.3%), major bleeding complications (3.1% vs. 0%), and incomplete bladder emptying 6 weeks after surgery (3.7% vs. 0%) (P≤0.05 for all comparisons). CONCLUSIONS A prophylactic midurethral sling inserted during vaginal prolapse surgery resulted in a lower rate of urinary incontinence at 3 and 12 months but higher rates of adverse events. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Womens Health; OPUS ClinicalTrials.gov number, NCT00460434.).

Outcome of a Randomized, Double-Blind, Placebo Controlled Trial of Botulinum A Toxin for Refractory Overactive Bladder

PURPOSE We determined the effectiveness of cystoscopic administration of botulinum-A toxin compared to placebo for the treatment of urinary incontinence in subjects with idiopathic overactive bladder. MATERIALS AND METHODS Subjects were recruited from the Division of Urogynecology at the University of Rochester. Inclusion criteria were overactive bladder refractory to anticholinergic medications, multiple daily incontinence episodes and a 24-hour pad weight of 100 gm or greater. Subjects with low leak point pressures, increased post-void residual volume or neurological etiologies were excluded from study. Subjects were randomized to placebo or to 1 of 2 doses of botulinum-A toxin. The detrusor was injected at 8 to 10 sites above the trigone. Evaluations were performed at baseline, and at 3 and 6 weeks after injection, and included bladder diaries, pad weights, quality of life questionnaires and urodynamic studies. RESULTS A total of 22 subjects participated in stage 1 of this 2-stage study. We report on the outcomes of stage 1 of this study. Because stage 2 is still ongoing and investigators remain blind to the doses of botulinum-A toxin, the 2 botulinum-A toxin groups were combined for this report. There were no differences in mean baseline measurements between the 2 groups. Statistically significant improvements in daily incontinence episodes, pads changed per day and quality of life questionnaires were seen in the botulinum-A toxin group with no changes in the placebo group. No change in nocturia, daily voiding frequency, peak flow or detrusor pressure was seen in either group. Of 15 subjects 4 (26%) receiving botulinum-A toxin had a post-void residual volume of 200 cc or greater and 1 subject required intermittent catheterization. Four subjects experienced a urinary tract infection, 2 (13%) in the botulinum-A toxin group and 2 (28%) in the placebo group (not significant). CONCLUSIONS Botulinum-A toxin can significantly reduce urge urinary incontinence due to overactive bladder at 6 weeks. However, there is a risk of urinary retention requiring self-catheterization.

BLADDER ENDOMETRIOSIS: CONSERVATIVE MANAGEMENT

PURPOSE We evaluate the characteristics of women with bladder endometriosis successfully treated with hormonal therapy. MATERIALS AND METHODS The records of 14 patients with a mean age of 48.7 years (range 26 to 71) diagnosed with bladder endometriosis on cystoscopic evaluation were reviewed for presenting complaints, findings and response to therapy. RESULTS The most frequent presenting complaints were urgency (78%), frequency (71%), suprapubic pain (43%), urge incontinence (21%) and dyspareunia (21%). Of the patients 86% did not have a history of recurrent urinary tract infections, 6 (42%) had a history of endometriosis, including 3 who were previously treated with hysterectomy/oophorectomy and 8 (57%) were on some form of therapy for estrogen deficiency. In all patients endometrial implants were identified on cystoscopic examination. In 2 patients the endometrioma correlated to lesions on the serosal surface of the bladder during laparoscopic evaluation. Of the patients 13 were treated either with low dose oral contraceptives, decrease or elimination of the estrogen component of the present regimen or addition of progesterone to therapy, and 12 (92%) reported sustained improvement of symptoms at a mean of 18.6 months (range 8 to 24). CONCLUSIONS In more than 70% of cases the presenting symptoms of bladder endometriosis are identical to those of interstitial cystitis. Therefore, endometriosis should always be considered in the patient referred for frequency, urgency and pain with no documented infection. Hormonal therapy is reasonable and effective management for bladder endometriosis. This option preserves fertility, making it especially attractive to younger women.

Efficacy and adverse events of sacral nerve stimulation for overactive bladder: A systematic review.

To systematically review the literature regarding efficacy and adverse events of sacral nerve stimulation (SNS) via the InterStim device for treatment of women with refractory overactive bladder (OAB).

Outcome in 104 pubovaginal slings using freeze-dried allograft fascia lata from a single tissue bank.

We describe our experience with the use of allograft fascia lata for the treatment of stress urinary incontinence. One hundred and four patients underwent allograft fascia lata pubovaginal slings. Preoperatively, all were evaluated by a detailed urogynecologic evaluation, voiding diary, and pelvic examination. The pubovaginal sling was performed using a 2x15-cm freeze-dried nonirradiated cadaveric fascia lata specimen. Outcome measures were assessed by a urogynecologic questionnaire, pad usage, and disease-specific quality-of-life questionnaires. Eighty-eight percent (91 of 104) responded to a mailed urogynecology and disease-specific quality-of-life questionnaire with an average follow-up period of 19. 4 +/- 10.3 months. The mean preoperative daily pad usage was 4.6 +/- 3.0, postoperatively pad usage was 1.1 +/- 1.4 (P < 0.0001). Urge incontinence resolved in 41% (n = 24) of the 59 patients who complained of this preoperatively. Eighty-seven percent of the responders indicated that urinary incontinence was not substantially affecting their daily life. As in our preliminary report, the use of freeze-dried allograft pubovaginal sling continues to provide good results without adverse outcomes. A prospective, randomized comparison of autologous versus allograft slings and a review of preparation techniques used by tissue banks are needed.

VARIATIONS IN STRATEGY FOR THE TREATMENT OF URETHRAL OBSTRUCTION AFTER A PUBOVAGINAL SLING PROCEDURE

PURPOSE We evaluated the success of several techniques for treating urethral obstruction and erosion after a pubovaginal sling procedure. MATERIALS AND METHODS Between April 1998 and June 1999, 32 women 33 to 79 years old (average age 62) who underwent a pubovaginal sling procedure with various materials were referred for the assessment of urethral obstruction. Patients were evaluated with a urogynecologic history, physical examination, voiding diary, cystoscopy and video urodynamics. Surgical procedures to resolve urethral obstruction were performed transvaginally and the specific techniques used were based on the type of sling material, urethral erosion and concomitant stress incontinence or other urethral pathology. Outcome measures were assessed by disease specific quality of life questionnaires, voiding diary and urogynecologic questionnaire. RESULTS Preoperatively 30 of the 32 women (93.7%) noticed urge incontinence, 20 (62.5%) performed intermittent self-catheterization, 6 (18.7%) had an indwelling catheter and 3 (9%) complained of concomitant stress urinary incontinence. After the sling takedown 29 patients (93.5%) achieved efficient voiding within week 1 postoperatively. Urge incontinence symptoms resolved in 20 cases (67%) but stress incontinence developed in 3 (9%). Of the 32 women 27 (84%) indicated that continence was much better than before the initial sling procedure. CONCLUSIONS Managing urethral obstruction after a pubovaginal sling procedure is challenging. Using various techniques based on sling material, urethral erosion and bladder neck integrity a successful outcome is possible in the majority of cases.

Single-Incision Mini-Sling Compared With Tension-Free Vaginal Tape for the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial.

OBJECTIVE: To compare the efficacy of a single-incision mini-sling, placed in the “U” position, with tension-free vaginal tape (TVT) in the treatment of stress urinary incontinence. METHODS: Women with urodynamic stress incontinence with or without genital prolapse were randomized to receive a mini-sling or TVT (N=263). Those randomized to the mini-sling received two “sham” suprapubic incisions to facilitate blinding. The primary outcome was subjective cure (absence of any urinary incontinence or retreatment) as assessed at 1 year. This trial was a noninferiority study design. RESULTS: Participants receiving the mini-sling were less likely to have a bladder injury (0.8% compared with 4.8%; P=.0.46), more likely to be discharged without a catheter (78.5% compared with 63%; P=.008), and had less pain for postoperative days 1–3. One year after surgery, the rate of cure was similar between treatment groups (mini-sling 55.8% compared with TVT 60.6%; mean difference, 4.8%; 95% confidence interval, −16.7 to +7.2); however, this did not meet our predefined noninferiority criteria of −12%. Incontinence severity at 1 year was greater with the mini-sling than with TVT (mean severity score ± SD: 2.2±2.7 compared with 1.5±1.9; P=.015), resulting predominantly from a higher proportion of participants with “severe” incontinence postoperatively (16% compared with 5%; P=.025). CONCLUSION: The mini-sling placed in the “U” position results in similar subjective cure rates to TVT 1 year after surgery but postoperative incontinence severity is greater with the mini-sling than with TVT. LEVEL OF EVIDENCE: I

Conditional and continuous electrical stimulation increase cystometric capacity in persons with spinal cord injury.

Individuals with spinal cord injury (SCI) exhibit neurogenic detrusor overactivity (NDO) causing high intravesicle pressures and incontinence. The first aim was to measure changes in maximum cystometric capacity (MCC) evoked by electrical stimulation of the dorsal genital nerve (DGN) delivered either continuously or conditionally (only during bladder contractions) in persons with SCI. The second aim was to use the external anal sphincter electromyogram (EMGEAS) for real‐time control of conditional stimulation.

Management of female genitourinary fistulas: transvesical or transvaginal approach?

PURPOSE We reviewed 25 female genitourinary fistula repairs performed at our institution from 1993 to 1997. MATERIALS AND METHODS Our series comprised 7 primary vesicovaginal, 6 recurrent vesicovaginal, 7 complex, 1 ureterovaginal and 4 urethrovaginal fistulas. Postoperative followup ranged from 8 months to 5 years. RESULTS Overall, 92% of the patients were cured (23 of 25). The 2 failures occurred in patients with a history of pelvic malignancy involving adjuvant therapy. CONCLUSIONS Complex irradiated vesicovaginal fistulas require staged repairs, often with pedicle flaps. However, primary repair of uncomplicated vesicovaginal fistulas is highly successful. Limited transvesical repair of these fistulas offers reliable success with minimal morbidity and hospital stay comparable to those of the transvaginal approach.

Cost-Effectiveness of Sacral Neuromodulation Versus Intravesical Botulinum A Toxin for Treatment of Refractory Urge Incontinence

PURPOSE We determined the cost-effectiveness of sacral neuromodulation vs intravesical botulinum toxin A for the treatment of refractory urge incontinence. MATERIALS AND METHODS We developed a Markov decision model using a societal perspective to compare costs (2008 U.S. dollars) and effectiveness (quality adjusted life-years) of sacral nerve stimulation and botulinum toxin A. Our primary outcome was the incremental cost-effectiveness ratio, which was defined as (sacral nerve stimulation cost - botulinum toxin A cost)/(sacral nerve stimulation quality adjusted life-year - botulinum toxin A quality adjusted life-year). Sensitivity analyses were performed to assess the impact of varying efficacy, costs and adverse event rates over the range of reported values. RESULTS In the base case scenario sacral nerve stimulation was more expensive (