Cost-effectiveness Analysis: Autologous Rectus Fascial Sling Versus Retropubic Midurethral Sling for Female Stress Urinary Incontinence.

IMPORTANCE: There are limited data on the economic comparison between retropubic midurethral sling and autologous fascial sling. OBJECTIVE: This study aims to evaluate the cost-effectiveness of autologous rectus fascial sling compared with retropubic midurethral sling from both hospital and health care perspectives. STUDY DESIGN: A decision tree model was developed with 1 year of follow-up. We included variables such as objective success rate, complications and subsequent treatments, and retreatment for incontinence. The model included the index procedure and 1 retreatment for stress urinary incontinence. Cost estimates were calculated from both hospital and health care perspectives. The outcomes were expressed in incremental cost-effectiveness ratio (ICER) or cost per quality-adjusted life-year (QALY). An ICER <$50,000/QALY was considered cost-effective. RESULTS: From a hospital perspective, the overall cost of retropubic midurethral sling was higher than autologous rectus fascial sling ($2,348.94 vs $2,114.06), but was more effective (0.82 vs 0.80 QALYs). The ICER was $17,452/QALY. From a health care perspective, the overall cost of autologous rectus fascial sling was higher than retropubic midurethral sling ($4,656.63 vs $4,630.47) and was less effective. Retropubic midurethral sling was the dominant strategy, with ICER of -$1,943.32/QALY. If the success rate of autologous rectus fascial sling was ≥84.39%, or the cost of retropubic midurethral sling surgery was > $2,654.36, then autologous rectus fascial sling would become cost-effective. CONCLUSIONS: Retropubic midurethral sling is the cost-effective treatment from the hospital perspective and the dominant treatment from the health care perspective. However, changes in the costs and success rates of surgical procedures can alter the cost-effectiveness results.

The Effect of Preoperative Fiber on Postoperative Bowel Function After Pelvic Reconstructive Surgery: A Randomized Controlled Trial.

IMPORTANCE: There are limited studies evaluating the effect of preoperative interventions on postoperative bowel function after prolapse surgery. OBJECTIVE: The objective of this study was to evaluate if preoperative fiber intake reduces time to first bowel movement after surgery for pelvic organ prolapse. STUDY DESIGN: We performed a randomized controlled trial of women undergoing pelvic organ prolapse surgery between July 2019 and May 2021. Participants were recruited at their preoperative visit and randomized to receive either 3.4 g psyllium fiber supplementation twice a day for 1 week before surgery or no fiber supplementation before surgery. Postoperative bowel regimen was standardized for both groups. Participants completed a bowel diary for their first postoperative bowel movement after surgery characterized by the Bristol Stool Scale and any associated pain or urgency. The primary outcome was time to first bowel movement. Secondary outcomes included pain associated with first bowel movement. RESULTS: Eighty-four patients were enrolled in the study. Seventy-one patients had complete data for primary analysis, with 35 patients in the intervention group and 36 patients in the control group. Demographic and perioperative characteristics were similar between the groups. There was no difference found between the groups with respect to time to first bowel movement (control: 68.3 [SD, 25] hours vs intervention: 66.5 [SD, 23] hours, P = 0.749). There was no difference found with pain associated with first bowel movement (visual analog scale median [interquartile range] control: 2.0 [0.0-4.0] vs intervention: 2.0 [1.0-4.0]; P = 0.655). CONCLUSIONS: Preoperative fiber supplementation before prolapse surgery does not improve time to first bowel movement after surgery.

The Effect of Phenazopyridine on Immediate Postoperative Voiding After Prolapse Surgery: A Randomized Controlled Trial.

OBJECTIVES: The objective of our study was to determine if phenazopyridine reduces void trial (VT) failure rates after prolapse surgery. METHODS: A single-institution randomized controlled trial was conducted comparing a second dose of phenazopyridine 200 mg on postoperative day 1 versus no additional phenazopyridine in women undergoing prolapse surgery. All subjects (including controls) received 200 mg of phenazopyridine preoperatively for ureteral patency verification. The intervention group received a second dose of phenazopyridine 200 mg the morning of postoperative day 1. The primary outcome was assessed using a standardized VT. Secondary outcomes included pain, opioid usage, urinary tract infections, and prolonged or recurrent urinary retention. An intent-to-treat analysis was performed with a χ2 test to compare failure rates between the intervention and control groups. RESULTS: We enrolled 152 women, and 76 were randomized to each group. There was no difference in VT failures between the 2 groups-34% failed without phenazopyridine on postoperative day 1, and 42% failed with phenazopyridine on postoperative day 1 (P = 0.326). Subject characteristics were similar across both groups. Pain scores immediately before the VT were 3 out of 10 in both groups (P = 0.206), with no difference in opioid consumption (P = 0.750). There were no differences in the rate of urinary tract infections or prolonged or recurrent urinary retention between the groups (P = 0.304 and P = 0.745). CONCLUSIONS: While previous studies suggested an improvement in immediate postoperative voiding with phenazopyridine, our randomized controlled trial does not support this.

Accuracy of Bladder Scanner for the Assessment of Postvoid Residual Volumes in Women With Pelvic Organ Prolapse.

OBJECTIVES: The aim of the study was to evaluate the accuracy of the bladder scanner in assessing postvoid residual (PVR) volumes in patients with pelvic organ prolapse (POP). METHODS: We performed a prospective parallel cohort study evaluating the accuracy of the BVI 3000 bladder scanner in patients with POP. Patients with POP to the hymen were offered inclusion. Primary outcome was the absolute difference between bladder scanner and catheterization PVR. We also investigated the effect of prolapse stage on bladder scanner accuracy. A prevoid bladder volume was obtained by bladder scan. Subjects voided volume was then collected. A PVR was obtained by bladder scan, followed by a PVR by catheterization. Descriptive statistics, Wilcoxon signed-rank test, linear regression analysis, and sensitivity/specificity analysis were performed. RESULTS: We enrolled 87 subjects. There was a statistically significant difference between catheter and bladder scan PVR, with an absolute median difference of 20 mL (SD = 37.7), P < 0.001. Linear regression analysis showed a difference between mild and advanced prolapse groups. The regression coefficients of the mild prolapse group and advanced prolapse were 0.91 (confidence interval = 0.75-1.06) and 0.66 (confidence interval = 0.54-0. 78), P = 0.015, respectively, indicating a deterioration of accuracy of the bladder scanner for advanced prolapse. The sensitivity of the bladder scanner identifying catheterized PVR volumes less than 100 mL was 93.7%. For catheter PVRs greater than 100 mL, the specificity of the bladder scanner was 72.7%. CONCLUSIONS: Bladder scanner PVRs are less accurate in advanced prolapse, and PVRs of greater than 100 mL should be confirmed by catheterization.

The Effect of Oral Phenazopyridine on Perioperative Voiding After Midurethral Slings (EPIPhANy Study).

OBJECTIVE: To determine the effect of preoperative oral phenazopyridine on postoperative voiding dysfunction in women undergoing a retropubic midurethral sling. METHODS: A single-institution randomized clinical trial was performed from September 2015 to March 2017, comparing 200 mg of oral phenazopyridine versus no phenazopyridine in patients undergoing a retropubic midurethral sling under general anesthesia with no concomitant procedures. A power calculation indicated that we required at least 40 subjects per arm. Preoperative demographics, intraoperative medications, blood loss, and complications were recorded. A standardized voiding trial was performed before discharge. Voiding dysfunction was determined by the proportion of subjects who failed a postoperative voiding trial. Pain scores were obtained before and 2 to 3 hours after the surgical procedure. Patient characteristics and surgical data were compared using χ, Fisher exact test, or Wilcoxon rank sum test. RESULTS: Ninety-two subjects were enrolled in the study. Three patients cancelled their surgery and 1 had an intraoperative urethral injury, leaving 88 patients for the final analysis (44 per arm). Patient demographics showed no differences between groups. Phenazopyridine did not reduce the proportion of patients who failed the voiding trial (27%) compared with subjects who did not receive the medication (21%) (P = 0.453). Postoperative visual analog pain scores were higher in those not receiving phenazopyridine (1.76 vs 1.21, P = 0.046), but after adjusting for the difference in preoperative and postoperative pain scores, the groups showed no difference (P = 0.087). CONCLUSIONS: Our prospective trial shows that phenazopyridine has no effect on short-term postoperative voiding dysfunction. This condition appears to be multifactorial, and further research is needed.

Knot integrity using different suture types and different knot-tying techniques for reconstructive pelvic floor procedures.

INTRODUCTION AND HYPOTHESIS: Surgeons use a variety of sutures and knot-tying methods during pelvic reconstructive procedures. We hypothesized that knot-strength integrity will be similar with regards to type of knot, type of suture, and the knot-tying process. METHODS: Using six different suture materials, flat square knots and slip knots were tied robotically and by hand by two surgeons. Knot integrity was evaluated using an Instron 5544 machine. We measured force and elongation at suture failure or knot slippage (whichever came first) as well as force at 3-mm displacement. RESULTS: Four hundred and thirty-two knots were tie; one unraveled before the analysis, and 431 were tested. Three hundred and ninety-two knots reached or surpassed tensile strength of 30 N, the force at which tissue itself will fail. Knots tied with polyglyconate suture achieved the greatest tensile strength and those with OO-polydioxanone had the lowest. Hand-tied knots, regardless of technique and suture material, had greater tensile strength but greater elongation than robotically tied knots. Slip knots and flat square knots have similar integrity regardless of the tying technique. CONCLUSION: Hand-tied knots had greater tensile strength than robotic knots, but the strength to break all knots required supraphysiological conditions. The decision to use a specific type of suture based on strength is not supported by our results, suggesting that surgeons may choose sutures based on other characteristics and personal comfort.

The Effect of Preoperative Phenazopyridine on Urinary Retention Following Midurethral Sling.

OBJECTIVE: The aim of this study was to determine the effect of preoperative oral phenazopyridine on short-term voiding dysfunction in patients undergoing a retropubic midurethral sling. METHODS: We conducted a retrospective cohort study in subjects undergoing a retropubic midurethral sling comparing those who received preoperative oral phenazopyridine with those who did not. We included all women who underwent a retropubic midurethral sling without concomitant procedures under general anesthesia at our institution. Slings were placed by either suprapubic or transvaginal approach, per surgeon's preference. Demographics and intraoperative data on preoperative dose of phenazopyridine and medications linked to voiding dysfunction were captured. RESULTS: One hundred seventy-four subjects were identified. Twenty-five subjects failed to meet inclusion and exclusion criteria and were excluded, and 149 subjects comprised the final groups. Eighty-two subjects (55.03%) received phenazopyridine, and 67 (44.97%) did not. Most subjects received a 200-mg dose (97.6%). Except for surgical approach, both groups receiving and not receiving phenazopyridine had similar demographic characteristics. Eighty-eight percent of the subjects who received phenazopyridine passed the voiding trial versus 73.1% (odds ratio, 2.98; 95% confidence interval, 1.23-7.17). After adjusting for medications, estimated blood loss, number of trocar passages, or bladder perforation, the patients receiving phenazopyridine were still more likely to pass the postoperative voiding trials compared with those who did not (odds ratio, 2.97; 95% confidence interval, 1.10-7.98). CONCLUSIONS: Our findings suggest that the preoperative administration of phenazopyridine may improve postoperative voiding function after a retropubic midurethral sling. Additional prospective trials are needed to confirm this finding.

A Randomized Controlled Trial of Patient-Controlled Valve Catheter and Indwelling Foley Catheter for Short-term Bladder Drainage.

OBJECTIVE: The purpose of this study was to compare catheter-related pain and quality-of-life scores between 2 catheters used after failed voiding trials following urogynecologic surgery. METHODS: Women failing an inpatient voiding trial requiring short-term catheterization after urogynecologic surgery were randomized to receive either a standard FC or a patient-controlled VC. Subjects completed a 6-item, visual analog scale-based postoperative questionnaire (POQ) and an outpatient voiding trial 3 to 7 days after surgery. Baseline demographic, surgical data, and results of the outpatient voiding trial were recorded. The primary outcome was the difference in mean score for catheter-related pain on the POQ, based on intent to treat. Secondary outcomes included between-group differences in means for individual POQ items and a calculated composite satisfaction score. The statistician was blinded to group assignment. RESULTS: Forty-nine subjects were randomized to FC (n = 24) and VC (n = 25). Two subjects, one in each group, were excluded from the primary analysis because of missing data. Mean age was 60.6 (SD, 12.5) years. Baseline characteristics were similar. Valve catheter users had a lower median catheter-related pain score (1.25 vs 2.3), but not significantly (P = 0.153). Valve catheter users had significantly lower median scores for frustration (1.2 vs 3.8; P = 0.018) and limitation on social activities (0 vs 7.6; P < 0.001). Mean composite satisfaction score was statistically significantly lower for the VC group (2.23 [SD, 1.83] vs 3.62 [SD, 1.95]; P < 0.01), suggesting greater satisfaction. CONCLUSIONS: Valve catheter and FC users report similar catheter-related pain. Valve catheter users scored better in overall satisfaction, frustration, and limitations on social activities.

Patient-focused websites related to stress urinary incontinence and pelvic organ prolapse: a DISCERN quality analysis.

INTRODUCTION AND HYPOTHESIS: The quality of information related to pelvic floor disorders is varied and understudied. Using a validated instrument we evaluated the quality of selected websites addressing treatment options for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). METHODS: English-language, patient-focused professional, governmental, and consumer websites related to POP and SUI were identified using the International Urogynecology Association (IUGA) list of continence societies worldwide, search terms, and provider nomination. Websites were evaluated by 10 providers at an academic medical center, representing urogynecology (6), urology (3), and general gynecology (1). Quality assessment utilized the DISCERN instrument, a validated instrument consisting of 16 questions addressing the quality of consumer health information. RESULTS: Websites of 13 organizations met inclusion criteria and were assessed, 12 relating to SUI and 8 to POP. The websites with the highest mean total DISCERN score for POP were those of the IUGA, the American Society of Colon and Rectal Surgeons, and the American Urogynecologic Association, and for SUI, the National Association For Continence, the American Urological Association, and the IUGA. High correlations were obtained for the total DISCERN score and the overall quality scores for POP (0.76) and SUI (0.82). The most commonly omitted components of the DISCERN instrument were a clear statement of the content objectives, references or sources of the content, and a discussion of what patients could expect if they opted for no intervention. CONCLUSIONS: Available English-language professional websites written to inform patients about management choices for SUI and POP miss key components of quality patient information.

Acute urinary retention after cesarean delivery: a case-control study.

INTRODUCTION: This study aimed to identify risk factors for postpartum urinary retention (PPUR) after cesarean delivery (CD). METHODS: A case-control study design was used. Cases of PPUR after CD were identified using billing codes for CD and "urinary retention" and confirmed by chart review. Matched controls were identified in a 2:1 ratio using an obstetrics database and billing data. Patient demographics, operative, and anesthetic data were collected. Fisher exact tests and Wilcoxon rank sum tests were used to determine differences in medical risk factors, postoperative analgesic use, and catheter management between cases and controls. A modified Poisson conditional multivariate regression with robust error variances was used to estimate the odds ratios (ORs) for significant predictors. RESULTS: Thirty-four confirmed cases of PPUR were matched with 68 controls. The mean ages of cases and controls were 31 and 32 years, respectively. Cases and controls differed in gestational age (P = 0.01), diagnosis of diabetes (P = 0.05), and use of postoperative intravenous and oral narcotics (P < 0.01 and P = 0.03, respectively). In a multivariate model including these factors, increasing gestational age was associated with decreased risk of PPUR [OR, 0.07; 95% confidence interval (CI), 0.01-0.48; P < 0.01], whereas use of postoperative intravenous narcotics (OR, 4.51; 95% CI, 1.09-18.67; P = 0.038) and oral narcotics (OR, 4.99; 95% CI, 1.10-22.65; P = 0.037) were associated with increased risk. CONCLUSIONS: After matching for obstetric factors, use of postoperative narcotic analgesia was associated with increased risk of PPUR. Other operative and anesthetic factors had no association. Multicenter prospective studies are needed to investigate this association.

Expectant management of cystotomy at the time of midurethral sling placement: a retrospective case series.

INTRODUCTION AND HYPOTHESIS: Cystotomy is one of the most common complications of retropubic midurethral sling placement. Some centers manage cystotomy with prolonged catheter drainage, and there are few published studies evaluating this practice. The purpose of this study is to review postoperative outcomes of patients who experienced cystotomy at the time of sling placement and did not undergo prolonged catheter drainage. METHODS: This is a retrospective review of all patients undergoing midurethral sling placement complicated by a cystotomy at the University of Rochester between 2004 and 2009. Outpatient and inpatient records were reviewed and data collected include demographics, intraoperative details, voiding trial results, postoperative complications, and voiding function. Descriptive statistics were performed. RESULTS: Between 2004 and 2009, 30 subjects experienced a cystotomy of the 374 subjects that had a midurethral sling placed, all by a suprapubic approach. There were 25 patients who underwent a voiding trial on the day of surgery and 20 (80 %) were discharged home without prolonged drainage. Five subjects (20 %) had urinary retention and were discharged with an indwelling catheter. All five successfully voided within 4 days of discharge. No subject required subsequent catheterization for any reason and at the 6-week postoperative evaluation all subjects denied voiding dysfunction or irritative bladder symptoms. No subject required additional intervention and postoperative complications were rare. CONCLUSIONS: In this study, the majority of subjects experiencing a cystotomy during midurethral sling placement were successfully discharged home the day of surgery without catheter drainage. The results suggest that prolonged catheter drainage after a cystotomy during midurethral sling placement may be unnecessary.

Evaluating the most effective distribution strategies to assure administration of pandemic H1N1 influenza vaccine to New York State children and adolescents: evaluation using the New York State Immunization Information System.

OBJECTIVE: To examine differences in H1N1 influenza vaccine distribution strategies that may impact the ability to rapidly administer vaccine during a pandemic or public health emergency. DESIGN: Retrospective evaluation of immunization data in the New York State Immunization Information System (NYSIIS). SETTING: Analysis of existing NYSIIS data. PARTICIPANTS: Children and adolescents younger than 19 years for whom information on at least 1 H1N1 influenza vaccine was present in NYSIIS. MAIN OUTCOME MEASURE(S): Median time to administer vaccines to children and adolescents younger than 19 years by December 31, 2009, by county; venue of H1N1 vaccine administration (local health department [LHD] or private medical provider); comparison of immunization-seeking behavior for routine childhood vaccinations and H1N1 vaccine. RESULTS: A total of 459 189 first or only doses of H1N1 influenza vaccine were recorded in NYSIIS as being administered to New York State, outside of New York City, children aged less than 19 years, between October 2, 2009, and December 31, 2009. Overall, LHD administered 31% of H1N1 vaccine doses; in counties having population less than 100,000, LHD administered 63% of H1N1 doses compared with 23% in counties having population more than 100,000. Time to median administration was faster for LHD in smaller counties and similar for LHD and private medical providers in larger counties. Children who always received routine childhood immunizations either within or outside of their county of residence often had the same practice for H1N1 vaccine, with 85% of children following these patterns. Children who did not follow these patterns were more likely to receive H1N1 influenza vaccine through LHD. CONCLUSIONS: Local health departments were able to rapidly administer large quantities of H1N1 influenza vaccine, and patterns of health care seeking relying on increased use of LHD needs to be further studied for future public health emergency planning.

Bowel function after minimally invasive urogynecologic surgery: a prospective randomized controlled trial.

OBJECTIVES: The goals of this study were to assess the effect of a standardized postoperative bowel regimen of over-the-counter medications on (1) time to first bowel movement (BM) and (2) pain level associated with first BM in subjects undergoing minimally invasive urogynecologic surgery. METHODS: Eligible patients scheduled to undergo minimally invasive urogynecologic surgery were offered participation. Enrolled subjects were randomized by computerized schedule. Demographic and perioperative data were collected. Subjects completed a validated questionnaire preoperatively and postoperatively assessing preexisting constipation, frequency and consistency of bowel movements, use of pain medications, mean daily pain level (using visual analog scale), stool consistency, and pain associated with first postoperative bowel movement. The control group was instructed to take docusate sodium twice daily postoperatively. The treatment group took docusate sodium plus Miralax, fiber wafers, and bisacodyl suppositories as directed by protocol. Wilcoxon or t testing was used to compare continuous variables; χ testing was used for categorical relationships, and backward-elimination multiple regression was used to assess independent effects. RESULTS: Seventy-two subjects were enrolled and randomized. Twelve subjects withdrew, leaving 60 (30 per group) completing the study. There were no statistically significant differences between groups in baseline characteristics. Mean (SD) age was 63 (9) years for the control group and 58 (10) for the study group (P = 0.06). Mean pelvic organ prolapse stage was III in each group. The mean (SD) operating room time was 198 (65) minutes for the controls and 216 (74) for the study subjects. Sixty-five percent underwent robot-assisted surgery (50% hysterectomy and 63% sacrocolpopexy). Ninety-eight percent of surgeries were performed under general anesthesia.Before adjustment, the mean (SD) time to first BM was 77 (24) hours in controls versus 64 (21) in the study patients (P = 0.03). Using multiple regression, baseline frequency of defecation (1-2 BMs/wk) was directly associated with the time to first BM (added 25.2 hours; P = 0.009) and being in the study group was inversely associated (first BM, 11.7 hours sooner; P = 0.04). No other variables were retained.There was no difference in pain associated with first postoperative BM (visual analog scale, 3.6 (3.2) vs 3.7 (2.8); P = 0.98), but those with prior complaints of vaginal or rectal splinting had higher pain scores (1.9 and 2.8 points higher, respectively; P = 0.04 for both). There was a trend toward higher pain scores with higher postoperative daily narcotic intake (P = 0.06). No other variables were retained.There was a significant difference in recorded compliance between control versus study regimens (94% vs 81%, respectively; P = 0.002). CONCLUSIONS: Mean time to first postoperative BM after minimally invasive urogynecologic surgery is more than 3.5 days with use of docusate sodium alone and is only slightly shorter when combination therapy is used. First BM after surgery is considered to be painful despite the use of medications. Future studies targeting postoperative discomfort/pain with defecation could target preoperative bowel regimens or more aggressive postoperative interventions. Regimens should remain simple to increase compliance.

Comparison of 2 techniques to predict voiding efficiency after inpatient urogynecologic surgery.

PURPOSE: We compared 2 techniques used to assess adequate postoperative bladder emptying. MATERIALS AND METHODS: We performed a prospective, randomized, crossover study of 2 voiding trial techniques. 1) For back fill the bladder is filled with 300 cc saline before the Foley catheter is removed. 2) For auto fill the catheter is removed and the bladder is allowed to fill spontaneously. Patients were randomized into 2 groups for voiding trials, including group 1-auto fill followed by back fill or group 2-back fill followed by auto fill. Within 15 minutes of each void we measured post-void residual urine by straight catheterization. A void of two-thirds or greater of total bladder volume (voided volume plus post-void residual urine) at void 2 of the 2 voids was considered successful voiding. Patients who voided successfully were discharged home without a urethral catheter. We used the chi-square test with κ to determine successful bladder emptying. RESULTS: We recruited 79 patients, of whom 65 with a mean age of 59.7 years (range 33 to 81) had complete data sets available for analysis. Of the patients 38 (58%) underwent prolapse repair only, 1 (2%) underwent a continence procedure only and 26 (40%) underwent each procedure. The back fill void trial correlated better with a successful voiding trial than the auto fill trial (κ = 0.91, 95% CI 0.81-1.00 vs κ = 0.56, 95% CI 0.39-0.74). Overall 40.5% of patients had an unsuccessful void trial on day 1 postoperatively and were discharged home with a catheter. None subsequently experienced urinary retention. CONCLUSIONS: The back fill technique appears to be a better predictor of adequate postoperative bladder emptying than the auto fill technique for inpatient void trials.

Recovery after robot-assisted laparoscopic sacrocolpopexy: the patients' perspective.

Little information exists about recovery after robot-assisted laparoscopic sacrocolpopexy. We sought to report on subjects' perioperative experience. Subjects were queried about resumption of activities such as work and driving, bowel function, whether recovery went as expected, and whether they would recommend this surgery. Use of pain medications, pain scores, and perioperative data were collected N = 21. All would recommend surgery to a friend. 13/18 (72%) felt their recovery went better than expected, and none responded it was worse than expected. 9/21 (43%) did not use narcotics after the day of surgery, with 15/21 (71%) no longer taking narcotics by postoperative day 4. Fifty-five percent experienced their first postoperative bowel movement as painful. Based on this survey, most patients undergoing robot-assisted laparoscopic sacrocolpopexy will not require narcotics beyond postoperative day 3. Nonsteroidals are the mainstay of pain management. This survey highlights the importance of preventing postoperative constipation/ painful defecation.

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.

Inherited pelvic organ prolapse in the mouse: preliminary evaluation of a new murine model.

The objective of this study was to report the initial anatomic, radiographic, and genetic evaluations of a novel form of spontaneous pelvic organ prolapse (S-POP) in mice. We observed S-POP in a colony of UPII-SV40T transgenic mice developed for studies on bladder cancer. We utilized magnetic resonance imaging and necropsy to characterize this finding. We have established a breeding colony to identify inheritance patterns and for future studies. Selective breeding isolated the S-POP phenotype from the transgene. In contrast to other animal models, the S-POP mouse does not require an obligatory antecedent event to manifest pelvic organ prolapse. Necropsy and imaging demonstrate significant displacement of the pelvic organs distal to the pelvic floor in both sexes. The appearance of the POP is similar to that seen in the human female phenotype. Preliminary breeding studies indicate an autosomal dominant inheritance pattern. This mouse may be an effective animal model for the study of POP in humans.

Urinary incontinence secondary to severe labial agglutination.

The purpose of the study was to describe the presentation and management of urinary incontinence because of severe labial adhesions. Records of all patients diagnosed with labial agglutination and urinary incontinence at the Division of Gynecologic Specialties between January 1999 and February 2006 were reviewed. Clinical presentation, management, and treatment outcome were extracted from the records. Five subjects were identified. Mean age was 78 (range 59-87) years. Four subjects presented with mixed and one with urge urinary incontinence. Four reported change in flow of stream with voiding. Physical examination showed near-total occlusion of the introitus and urethral meatus in four subjects and partial occlusion in one subject. All were treated topically with estrogen and/or steroids. None of the subjects improved with conservative management, and all required lysis of the labial adhesions. Postoperatively, all were treated with daily topical estrogen and three with concurrent topical steroids. All subjects reported resolution of voiding dysfunction; three had complete resolution of their incontinence. Lysis of labial adhesions combined with postoperative topical estrogen and steroids appears to be an effective treatment in women with this condition.

Sensory nerve injury after uterosacral ligament suspension.

OBJECTIVE: Uterosacral ligament suspension is a technique that is performed commonly to suspend the prolapsed vaginal apex. This case series describes our experience with the clinical evaluation and management of lower extremity sensory nerve symptoms after uterosacral ligament suspension. STUDY DESIGN: Hospital and office medical records from our 2 institutions were reviewed from January 2002 to August 2005, and all women who underwent uterosacral ligament suspension through a vaginal approach were identified. Women with symptoms of buttock and posterior thigh pain during the 6-week postoperative period were identified, and detailed clinical information was abstracted from the charts. RESULTS: From 182 uterosacral ligament suspension procedures, 7 women were identified. The age range was 42 to 70 years. Concurrent procedures included 6 vaginal hysterectomies, 5 anterior repairs, 4 posterior repairs, 2 slings, and 1 bilateral salpingo-oophorectomy. Within 24 hours of the surgical procedure, all the women experienced similar, substantial sharp buttock pain and numbness that radiated down the center of the posterior thigh to the popliteal fossa in 1 or both lower extremities. The ipsilateral uterosacral ligament suture was removed within 2 days of the procedure in 3 women who had immediate subjective reduction in their pain and complete resolution of pain by 6 weeks. The remaining 4 women were treated with gabapentin and narcotics. Three women had resolution of the pain by 12 to 14 weeks after the operation, and the last woman's pain resolved gradually by 6 months. CONCLUSION: Women who undergo uterosacral ligament suspension are at risk of postoperative pain and numbness in a S2-4 distribution. These symptoms appear to be related to the placement of uterosacral ligament sutures and may be relieved either by prompt removal of the ipsilateral uterosacral ligament suture or with prolonged medical therapy.

Abdominal sacral colpopexy with allograft fascia lata: one-year outcomes.

OBJECTIVE: The purpose of this study was to assess 1-year outcomes of sacral colpopexy with the use of allograft fascia lata. STUDY DESIGN: Records of all subjects who underwent sacral colpopexy with allograft fascia lata from May 1, 2001, to April 30, 2003, were reviewed. Subjects underwent pre- and postoperative evaluation of prolapse with the pelvic organ prolapse quantification system. The Fisher's exact test was used to analyze the results. RESULTS: Allograft fascia lata was used for 24 colpopexies during this period. No significant intraoperative or postoperative complications or graft erosions occurred. Five subjects were lost to follow-up after 3 months. Analysis was performed on the remaining 19 subjects. Prolapse of stage 2 or more in compartments Aa, Ba, Ap, Bp, and C was preoperatively 50%, 74%, 78%, 84%, and 68% and postoperatively 11%, 16%, 21%, 26%, and 5%, respectively. CONCLUSION: Allograft fascia lata may be a suitable alternative to permanent mesh for sacral colpopexy, but longer-term outcomes and larger studies are needed.