Amanda L. Clark

Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence.

Objective To determine the incidence of surgically managed pelvic organ prolapse and urinary incontinence in a population-based cohort, and to describe their clinical characteristics. Methods Our retrospective cohort study included all patients undergoing surgical treatment for prolapse and incontinence during 1995; all were members of Kaiser Permanente Northwest, which included 149,554 women age 20 or older. A standardized data-collection form was used to review all inpatient and outpatient charts of the 395 women identified. Variables examined included age, ethnicity, height, weight, vaginal parity, smoking history, medical history, and surgical history, including the preoperative evaluation, procedure performed, and details of all prior procedures. Analysis included calculation of age-specific and cumulative incidences and determination of the number of primary operations compared with repeat operations performed for prolapse or incontinence. Results The age-specific incidence increased with advancing age. The lifetime risk of undergoing a single operation for prolapse or incontinence by age 80 was 11.1%. Most patients were older, postmenopausal, parous, and overweight. Nearly half were current or former smokers and one-fifth had chronic lung disease. Reoperation was common (29.2% of cases), and the time intervals between repeat procedures decreased with each successive repair. Conclusion Pelvic floor dysfunction is a major health issue for older women, as shown by the 11.1% lifetime risk of undergoing a single operation for pelvic organ prolapse and urinary incontinence, as well as the large proportion of reoperations. Our results warrant further epidemiologic research in order to determine the etiology, natural history, and long-term treatment outcomes of these conditions.

Epidemiologic evaluation of reoperation for surgically treated pelvic organ prolapse and urinary incontinence.

OBJECTIVE The purpose of this study was to measure the risk of reoperation for surgically treated pelvic organ prolapse and urinary incontinence in a community-based population. STUDY DESIGN A 5-year prospective, observational study was conducted of women who had undergone pelvic organ prolapse and urinary incontinence surgery in 1995. The cohort of 376 women was identified by International Classification of Diseases, 9th revision, and current procedural terminology codes in 149,554 reproductive-aged women within the Kaiser Permanente Northwest membership. RESULTS Thirty-six women underwent 40 cases of reoperation. By survival analysis, 13% of women underwent reoperation by 71 months. Having undergone previous pelvic organ prolapse and urinary incontinence surgery increased the risk of reoperation to 17% compared with 12% for women who underwent a first procedure (log rank, P=.04). No association was observed with age, body mass index, parity, previous hysterectomy not for prolapse, vaginal versus abdominal approach, severity of prolapse, ethnicity, chronic lung disease, smoking, previous corticosteroid use, and estrogen status. CONCLUSIONS Future reoperation is a significant risk of morbidity for women who undergo pelvic organ prolapse and urinary incontinence surgery.

Transvaginal electrical stimulation for female urinary incontinence

OBJECTIVE Our purpose was to determine the objective and subjective efficacy of transvaginal electrical stimulation for treatment of common forms of urinary incontinence in women. STUDY DESIGN A prospective, double-blind, randomized clinical trial included 121 women with either urinary incontinence caused by detrusor instability or genuine stress incontinence, or both (mixed incontinence). Participants used the assigned device for 8 weeks. Identical preintervention and postintervention assessment included multichannel urodynamic testing, quality-of-life scale, and urinary diaries. RESULTS A total of 121 women completed this study at four North American urogynecology centers. Detrusor instability was cured (stable on provocative cystometry) in 49% of women with detrusor instability who used an active electrical device (p = 0.0004, McNemars test), whereas there was no statistically significant change in the percentage with detrusor instability in the sham device group. There was no statistically significant difference between the preintervention and postintervention rates of genuine stress incontinence for either the active device group or the sham device group. CONCLUSION This form of transvaginal electrical stimulation may be effective for treatment of detrusor overactivity, with or without genuine stress incontinence.

Complications associated with transobturator sling procedures

This study aims to determine the complications associated with trans-obturator slings as reported to a national database. We required “MAUDE”, a database that collects reports of complications associated with medical devices and which is maintained by the Food and Drug Administration. We searched for complications associated with three different, commercially available trans-obturator slings. We then tabulated the results by type of complication, by date of occurrence, and by type of sling. Between January 2004 and July 2005, 140 reports of 173 complications associated with trans-obturator tapes were reported to the MAUDE database. Previously unreported injuries, such as obturator nerve injuries, large blood losses (≥600cc), and ischiorectal fossa abscesses, were documented. Serious complications occur with the trans-obturator tape systems, but the rates are unknown due to database limitations. The type of complication appears to differ between devices and this may reflect different implantation systems and different polypropylene mesh formulations. Improved tracking of device complications is necessary to maximize patient safety.

Quantitative electromyography of the anal sphincter after uncomplicated vaginal delivery

OBJECTIVE: Fecal incontinence in women is thought to be associated with sphincter laceration or pudendal nerve damage. A prolonged pudendal nerve terminal motor latency is evidence of profound nerve damage, but pudendal nerve terminal motor latency can be normal even when nerve injury has been sustained. We performed quantitative electromyography (EMG) to compare multiple motor unit action potential parameters between recently postpartum women and nulliparous women. METHODS: Standardized examinations were prospectively performed on 2 groups: 1) healthy nulliparous women without pelvic floor disorders (n = 28) and 2) asymptomatic women who were postpartum following vaginal delivery of their first child (n = 23). The examinations included pelvic organ prolapse quantification measurements, endoanal ultrasonography, pudendal nerve terminal motor latency, sacral reflexes, and concentric needle EMG using multiple motor unit action potential analysis. RESULTS: A mean of 11.5 (standard deviation [sd] 1.1) weeks had elapsed since first vaginal deliveries in the postpartum group. The mean fetal weight at delivery was 3,495 (sd 458) grams. There were no sphincter defects seen by ultrasonography. Compared with the nulliparous women, pudendal nerve terminal motor latency and sacral reflexes (clitoral-anal reflex, urethral-anal reflex) were not increased in the postpartum group. Each of the quantitative parameters (duration, amplitude, area, turns, and phases), measured from motor unit action potentials in the postpartum group, were larger than in the nulliparous group (P ≤ .004, nested analysis of variance [ANOVA]). CONCLUSION: Quantitative EMG using multiple motor unit action potential analysis can detect the presence after vaginal childbirth of subtle nerve injury not demonstrable by pudendal nerve terminal motor latency. Even asymptomatic women show evidence of pelvic floor nerve injury after uncomplicated deliveries. LEVEL OF EVIDENCE: II-2

Mesh erosion in robotic sacrocolpopexy.

Objective This study aimed to compare the incidence of mesh erosion after robotic sacrocolpopexy between women undergoing total and those undergoing supracervical hysterectomy (SH). Methods This is a retrospective cohort study of women who underwent sacrocolpopexy and concomitant hysterectomy using the DaVinci surgical robot between May 2007 and December 2010 at 2 sites. Baseline data were gathered before surgery. The primary outcome was mesh erosion identified during 3 months of follow-up. Results A total of 102 women underwent sacrocolpopexy, of whom 45 were with concomitant SH and 57 were with total hysterectomy (TH). Their mean age was 58 years, mean body mass index was 26.8 kg/m2, 98% were white, 6% smoked, and 25% were on systemic hormone replacement therapy. Mean preoperative Ba = +1.4, C = −2.2. These were not different between the 2 groups or by site. Within 3 months of surgery, mesh erosion was diagnosed in 8 women, all of whom had TH. No mesh erosions occurred in the SH group (14% vs 0%). Total hysterectomy mesh erosion rate at site 1 was 3% compared with 37% at site 2. Mesh type was the only identifiable difference between sites: self-cut polypropylene at site 1, precut polypropylene at site 2. Two women in the SH had abnormal uterine pathology: 1 endometrial adenocarcinoma and 1 focus of hyperplasia with atypia. Conclusions No mesh erosions were associated with SH within the first 3 months. In TH, the graft material used may be a modifiable factor needing further investigation. Unexpected abnormal uterine pathologic diagnosis remains a possibility with SH. Longer-term follow-up and a randomized trial are warranted to answer these questions.

Severity of pelvic organ prolapse associated with measurements of pelvic floor function.

This study tested the hypothesis that clinical measurements of the superficial perineum and of pelvic floor muscle (PFM) function correlate with the severity of pelvic organ prolapse. This retrospective cross-sectional study assessed 1037 women in an academic urogynecologic practice. Greatest descent of prolapse, by the Pelvic Organ Prolapse Quantification system, was correlated with two assessments of levator function—the Oxford grading scale and levator hiatus (LH) size measured by digital examination. Correlations were calculated using Pearson’s correlation for continuous variables and Kendall’s tau-b. Severity of prolapse correlated moderately with genital hiatus (GH) (r=0.5, p<0.0001) and with LH (transverse r=0.4, p<0.0001; longitudinal r=0.5, p<0.0001), but weakly with the Oxford grading scale (r=−0.16, p<0.0001). LH correlated with GH (r=0.5, p<0.0001) but not with perineal body (r=0.06, p=0.06). Both GH and LH size are associated with the severity of prolapse. LH size correlates more strongly to prolapse severity than assessment of PFM function by the Oxford grading scale.

“The cough game”: are there characteristic urethrovesical movement patterns associated with stress incontinence?

This study was carried out to determine whether five experts in female stress urinary incontinence (SUI) could discover a pattern of urethrovesical movement characteristic of SUI on dynamic perineal ultrasound. A secondary analysis of data from a case–control study was performed. Ultrasounds from 31 cases (daily SUI) and 42 controls (continent volunteers) of similar age and parity were analyzed. Perineal ultrasound was performed during a single cough. The five experts, blinded to continence status and urodynamics, classified each woman as stress continent or incontinent. Correct responses ranged from 45.7% to 65.8% (mean 57.4 ± 7.6). Sensitivity was 53.0 ± 8.8% and specificity 61.2 ± 12.4%. The positive predictive value was 48.8 ± 8.2% and negative predictive value was 65.0 ± 7.3%. Inter-rater reliability, evaluated by Cohen’s kappa statistic, averaged 0.47 [95% CI 0.40–0.50]. Experts could not identify a pattern of urethrovesical movement characteristic of SUI on ultrasound.

Surgical outcome of abdominal sacrocolpopexy with synthetic mesh versus abdominal sacrocolpopexy with cadaveric fascia lata.

Nineteen women who had an abdominal sacrocolpopexy (ASC) with synthetic mesh and 18 women who had an ASC with freeze-dried, irradiated cadaveric fascia lata returned for blinded pelvic organ prolapse quantification (POPQ) examinations. The mean relative vaginal descent (delta) from perfect total vaginal length in the mesh group was 1.1 (0.3) cm, and the delta in the fascia group was 2.8 (0.8) cm (p=0.02, Mann–Whitney U). The proportion of women with “optimal” surgical outcome in the mesh group was 89% and 61% in the fascia group (p=0.06, Fischer’s exact test). This study suggests that cadaveric fascia lata may not be a good choice for ASC.

Quantitative anal sphincter electromyography in primiparous women with anal incontinence

OBJECTIVE The purpose of this study was to determine whether evidence of denervation/reinnervation of the external anal sphincter is associated with anal incontinence symptoms immediately after delivery. STUDY DESIGN After a first vaginal delivery, 42 women completed an anal incontinence questionnaire. They also underwent concentric needle electromyography of the external anal sphincter. For each subject, motor unit action potential and interference pattern parameters were determined. RESULTS For the motor unit action potential, no difference was observed between patients with and without anal incontinence symptoms (t-test). For the interference pattern, the amplitude/turn was greater in subjects with fecal urgency (318 +/- 48 [SD] microV) and fecal incontinence (332 +/- 48 microV), compared with those without fecal urgency (282 +/- 38 microV) and fecal incontinence (286 +/- 41 microV; P = .02, t-test). CONCLUSION In this group of postpartum women with mild anal incontinence symptoms, interference pattern analysis shows evidence of denervation and subsequent reinnervation.