Percutaneous tibial nerve stimulation for the treatment of interstitial cystitis/bladder pain syndrome: a pilot study.

OBJECTIVES: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pain condition that requires multimodal management. The American Urologic Association includes sacral neuromodulation in the treatment algorithm for refractory IC/BPS. We sought to determine the rate of overall symptom improvement of IC/BPS symptoms, using validated measures, after treatment with percutaneous tibial nerve stimulation (PTNS), a form of peripheral neuromodulation. METHODS: This was a single-arm, dual-center, pilot study examining a standard PTNS protocol in subjects with IC/BPS. Our primary outcome was subject response of "moderately" or "markedly improved" on the Global Response Assessment (GRA) scale after 12-weekly PTNS sessions. Assuming a 60% response rate, 24 subjects were needed to detect a response rate between 40 and 80% with 95% confidence. Secondary objectives included change in urinary frequency on a 24-h bladder diary, bladder pain as measured by VAS and responses to validated questionnaires for pelvic pain and IC/BPS. RESULTS: Of 21 subjects enrolled, 16 initiated and 10 completed the PTNS treatment course. The GRA response rate was 40% at week 6 and 30% at week 12. Seventy percent of the cohort had some degree of improvement. There were no adverse events. CONCLUSIONS: While only a minority of subjects with IC/BPS were responders to PTNS per GRA criteria, 70% of the cohort had some degree of improvement. Due to low recruitment and loss to follow-up, we did not achieve our predetermined significance. However, our promising findings add to the limited literature on this subject.

Vaginal Hysterectomy in a Large Health Maintenance Organization: Retrospective Application of a Clinical Algorithm.

STUDY OBJECTIVE: The primary objective was to describe practice patterns of benign hysterectomy within a large community health maintenance organization (HMO) and evaluate clinical and surgeon characteristics associated with the performance of vaginal hysterectomy (VH). Secondary objectives were to retrospectively apply a VH algorithm to determine how our practice patterns conform, and compare rates of perioperative complications among patients who did and did not meet the algorithm. Patient and surgeon characteristics, and perioperative complications, were compared between patients who underwent VH and did or did not meet the VH algorithm. DESIGN: Retrospective cohort study. SETTING: Large community HMO. PATIENTS: Women undergoing benign hysterectomy. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Route of hysterectomy, patient and surgeon characteristics, perioperative complications. One hundred and thirty-one of 984 (13.3%) benign hysterectomies from January 1, 2013 to June 30, 2015 were vaginal. Patients who were vaginally parous, Hispanic, had normal preoperative uterine size and documentation of uterine descent were more likely to have VH (all p <.05). High-volume surgeons performed 18.8% of their hysterectomies vaginally, as compared to low-volume surgeons who performed 11.4% of their hysterectomies vaginally (p <.01). VH were more likely to be performed by surgeons with longer practice durations than non-vaginal hysterectomies (16.3 vs 12.2 years, p <.01). Seventy-five percent of patients who met the VH algorithm underwent non-vaginal hysterectomy and they had longer operative durations and higher rates of postoperative complications compared to patients who underwent VH. Conversely, patients who underwent VH despite not meeting the VH algorithm did not have significantly different rates of perioperative complications or blood loss than patients who met the VH algorithm. CONCLUSION: Seventy-five percent of patients deemed appropriate for VH by our algorithm underwent non-vaginal hysterectomy and had more postoperative complications and longer operative durations. Our data suggest that surgeon characteristics, including surgical volume and duration of practice, may explain some of this performance gap. These findings contribute additional insight into current practice patterns and describe clinical factors that should be included in VH algorithms.

Impact of surgical training on the performance of proposed quality measures for hysterectomy for pelvic organ prolapse.

BACKGROUND: Recent healthcare reform has led to increased emphasis on standardized provision of quality care. Use of government- and organization-approved quality measures is 1 way to document quality care. Quality measures, to improve care and aid in reimbursement, are being proposed and vetted in many areas of medicine. OBJECTIVES: We aimed to assess performance of proposed quality measures that pertain to hysterectomy for pelvic organ prolapse stratified by surgical training. The 4 quality measures that we assessed were (1) the documentation of offering conservative treatment of pelvic organ prolapse, (2) the quantitative assessment of pelvic organ prolapse (Pelvic Organ Prolapse-Quantification or Baden-Walker), (3) the performance of an apical support procedure, and (4) the performance of cystoscopy at time of hysterectomy. STUDY DESIGN: Patients who underwent hysterectomy for pelvic organ prolapse from January 1 to December 31, 2008, within a large healthcare maintenance organization were identified by diagnostic and procedural codes within the electronic medical record. Medical records were reviewed extensively for demographic and clinical data that included the performance of the 4 proposed quality measures and the training background of the primary surgeon (gynecologic generalist, fellowship-trained surgeon in Female Pelvic Medicine and Reconstructive Surgery, and "grandfathered" Female Pelvic Medicine and Reconstructive Surgery). Data were analyzed with the use of descriptive statistics. Inferential statistics with chi-squared tests were used to compare performance rates of quality measures that were stratified by surgical training. Probability values <.05 were considered statistically significant. RESULTS: Six hundred thirty patients who underwent hysterectomy for pelvic organ prolapse in 2008 had complete records available for analysis. Fellowship-trained surgeons performed 302 hysterectomies for pelvic organ prolapse; grandfathered Female Pelvic Medicine and Reconstructive Surgery surgeons performed 98 hysterectomies, and gynecologic generalist surgeons performed 230 hysterectomies. Fellowship-trained surgeons had the highest performance rates for individual quality measures (91.4-98.7%) and cumulative performance of all measures (80.8% of cases). Grandfathered Female Pelvic Medicine and Reconstructive Surgery surgeons performed significantly fewer measures (80.6-95.9% performance rate for individual measures; 65.3% cumulatively for all measures) than fellowship-trained surgeons and more than gynecologic generalists (64.3-70% for individual measures; 29.1% cumulatively for all measures). There was an association between surgeon training background and number of hysterectomies performed for pelvic organ prolapse, with specialist surgeons performing more hysterectomies. When quality measure performance was stratified by surgeon volume, similar significant associations were found, with high-volume surgeons performing more quality measures than low-volume surgeons. CONCLUSION: Within a large healthcare maintenance organization, fellowship-trained Female Pelvic Medicine and Reconstructive Surgery surgeons were more likely to perform proposed quality measures in women who underwent hysterectomy for pelvic organ prolapse compared with those surgeons without such training. Grandfathered Female Pelvic Medicine and Reconstructive Surgery surgeons performed measures more frequently than gynecologic generalists but less than fellowship-trained surgeons. Further study is indicated to correlate the proposed quality measures with clinical outcomes.

Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women: A Randomized Clinical Trial.

OBJECTIVES: We aimed to compare the efficacy of 2 commonly used contemporary vaginal estrogen administrations versus placebo for the prevention of urinary tract infection (UTI) in postmenopausal women with a clinical diagnosis of recurrent UTI (rUTI). METHODS: This was an investigator-initiated, multicenter, single-blind, randomized, placebo-controlled trial of vaginal estrogen (delivered via ring or cream) compared with placebo. Postmenopausal women with documented rUTI were randomized to receive either vaginal estrogen (via ring or cream) or placebo cream in a 1:1:1 fashion. The primary outcome was occurrence of UTI at 6 months. After 6 months, open-label use of ring or active cream was offered to all participants for an additional 6 months. Because of slower than expected recruitment, sample size calculations and block randomization schema were revised to combine estrogen groups (ring or cream) for statistical comparisons to placebo cream in a 1:1 fashion. RESULTS: Thirty-five women were randomized with 9 dropouts (1 ring, 2 cream, and 6 placebo) prior to the 6 months. Intention-to-treat analysis (assuming dropouts as failures) revealed fewer women treated with vaginal estrogen had a UTI within 6 months versus placebo (11/18 vs 16/17, respectively; P = 0.041). Per-protocol analysis revealed fewer subjects treated with vaginal estrogen had a UTI at 6 months (8/15 vs 10/11, respectively; P = 0.036). CONCLUSIONS: Commonly prescribed forms of vaginal estrogen with contemporary dosing schedules prevent UTIs in postmenopausal women with an active diagnosis of rUTI.

In Search of Mobile Applications for Patients With Pelvic Floor Disorders.

OBJECTIVES: The aims of the study were to identify patient-centered applications (apps) in female pelvic medicine and reconstructive surgery and to evaluate them using a modified APPLICATIONS scoring system. METHODS: A comprehensive list of female pelvic medicine and reconstructive surgery search terms was used to identify apps in the iTunes store. Apps that were eligible for scoring were in English, pertinent to the search term, patient centered, and accurate. All five authors independently evaluated eligible apps using a modified APPLICATIONS scoring system and subsequently reconciled differences by discussion. RESULTS: One hundred and fifty-seven terms were generated and searched in the iTunes Store to reveal 4127 apps. Twenty-three eligible apps were scored. Approximately half (47%, 11/23) of the apps were free. Twelve (52%) apps cited scientific literature or expert source. Only 8 (35%) of the apps were also available in the Google Play Store. "Squeezy," "LeakFreeMe," and "Stop UTI" received the highest score of 14. CONCLUSIONS: Few identified apps were accurate and subsequently scored. Our results demonstrate that when searching for apps, patients are likely to obtain information that is not relevant or inaccurate, even if the appropriate search term is used. By carefully excluding inaccurate apps, providers should feel confident that the 23 scored apps can be shared with patients.

Efficacy of Repeat Midurethral Sling for Persistent or Recurrent Stress Urinary Incontinence: A Fellows Pelvic Research Network Study.

OBJECTIVE: The objective of this study is to compare quality of life and success rates of repeat midurethral slings (RMUS) using retropubic (RP) and transobturator (TO) routes. MATERIALS AND METHODS: Multicenter retrospective cohort with prospective follow-up of patients undergoing RMUS from 2003 to 2016. Prospective Urinary Distress Inventory (UDI-6) and Patient Global Impression of Improvement (PGI-I) were collected by phone. Primary outcome was success of repeat sling by approach (RP vs TO), defined as responses of no to UDI-6 number 3 and very much better or much better on PGI-I. RESULTS: A total of 122 patients prospectively completed UDI-6. Average ± SD time to failure after initial sling was 51.6 ± 56.1 months; mean follow-up after repeat sling was 30.7 months. Route of initial sling was RP 30.3%, TO 49.2%, and minisling 16.4%. Of the patients, 55.8% met our success definition following RMUS. About 71.3% were very much better or much better on PGI-I, and 30.3% reported stress urinary incontinence (SUI) on UDI-6. Of the RMUS, 73.8% were RP versus 26.2% TO.There was no difference in success between repeat RP and TO routes (53.3% versus 63.3%, P = 0.34), nor for individual components: PGI-I response of very much better or much better (68.9% vs 78.1%), UDI-6 total score (25.9 vs 22.7, P = 0.29), or SUI on UDI-6 number 3 (32.2% vs 25.0%, P = 0.45), although the predetermined sample size was not met. No predictors of success or failure of RMUS were identified. CONCLUSIONS: Majority of patients are very much better or much better after RMUS, although 30% still report bothersome SUI. No difference in success was observed between RP and TO RMUS.

Paraurethral Leiomyoma in a 20 Year-old Woman: A Case Report.

We present the case of a 20 year-old woman with a vulvar mass, found to be a paraurethral leiomyoma. She subsequently underwent supermedial-approach paraurethral mass excision, distal urethral reconstruction and cystourethroscopy. Paraurethral leiomyoma make up approximately five percent of urethral tumors. This case depicts the presentation and treatment of a paraurethral leiomyoma in one of the youngest women reported in the literature.

A Large Retrospective Series of Pregnancy and Delivery After Midurethral Sling for Stress Urinary Incontinence.

OBJECTIVES: The aim of this study was to review the complete medical course, including safety, efficacy, and medical decision making, of patients who delivered a pregnancy after the placement of midurethral sling (MUS) within a large health maintenance organization. METHODS: We conducted a retrospective case series of patients within the Northern and Southern California Permanente Medical Group who were identified based on procedural codes for placement of MUS for stress urinary incontinence. Electronic medical records with MUS code were referenced against records of live births within the health care system. Demographic and clinical data were abstracted through extensive, standardized physician review of the electronic medical records of all identified patients. RESULTS: Twenty-six patients were identified and included in analysis. Sixteen patients had a retropubic MUS, and 10 had a transobturator MUS. Twenty-one of 26 patients reported subjective resolution of urinary incontinence after MUS. Fourteen of the 25 first deliveries after MUS were cesarean section (CS). Of these, 5 CS were elective primary for the indication of previous MUS, 5 were elective repeat CS, and the remaining 4 were for fetal indications. Eleven patients had spontaneous vaginal deliveries. There were no MUS-related pregnancy complications. One patient developed recurrent stress urinary incontinence postpartum, for which she underwent repeat MUS within a year resulting in cure of incontinence. CONCLUSIONS: This case series corroborates previous series demonstrating the safety and durability of MUS after subsequent pregnancy.

Pregnancy after transvaginal sling for stress urinary incontinence: a case series.

OBJECTIVES: The aim of this study is to assess the incidence, medical course, and outcomes of women who carried a pregnancy to delivery after the placement of a transvaginal mesh sling for treatment of stress urinary incontinence (SUI) in a closed health care system. METHODS: We conducted a retrospective case series of 15 women identified within the Kaiser Permanente Northern California region based on coding for placement of a sling for SUI. Records were cross-matched against the records of live births. The electronic medical records of subjects were extensively reviewed. RESULTS: Fifteen patients were identified and included in the analysis. Twelve patients had retropubic midurethral slings, 2 patients had transobturator slings, and one had a single-incision sling procedure. Ten of 15 were delivered via cesarean delivery. Five of the 15 patients had concomitant prolapse surgery at the time of sling placement; all of these patients had cesarean deliveries. There were no reports of voiding dysfunction or sling-related complications during pregnancy. Eleven of 15 patients were dry after the sling procedure, and 9 of the 15 were dry after delivery. No patients have had additional procedures or interventions for SUI after pregnancy. CONCLUSIONS: Our case series may suggest that vaginal delivery is not contraindicated and sling-related complications during pregnancy are not prevalent.