A new measure of sexual function in women with pelvic floor disorders (PFD): the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR).

INTRODUCTION AND HYPOTHESIS: The objective of this study was to create a valid, reliable, and responsive sexual function measure in women with pelvic floor disorders (PFDs) for both sexually active (SA) and inactive (NSA) women. METHODS: Expert review identified concept gaps and generated items evaluated with cognitive interviews. Women underwent Pelvic Organ Prolapse Quantification (POPQ) exams and completed the Incontinence Severity Index (ISI), a prolapse question from the Epidemiology of Prolapse and Incontinence Questionnaire (ISI scores), the Pelvic Floor Distress Inventory-20 (PFDI-20), and the Female Sexual Function Index (FSFI). Principle components and orthogonal varimax rotation and principle factor analysis with oblique rotation identified item grouping. Cronbach's alpha measured internal consistency. Factor correlations evaluated criterion validation. Change scores compared to change scores in other measures evaluated responsiveness among women who underwent surgery. RESULTS: A total of 589 women gave baseline data, 200 returned surveys after treatment, and 147 provided test-retest data. For SA women, 3 subscales each in 2 domains (21 items) and for NSA women 2 subscales in each of 2 domains (12 items) emerged with robust psychometric properties. Cronbach's alpha ranged from .63 to .91. For SA women, correlations were in the anticipated direction with PFDI-20, ISI, and FSFI scores, POPQ, and EPIQ question #35 (all p < .05). PFDI-20, ISI, and FSFI subscale change scores correlated with Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire International Urogynecological Association-revised (PISQ-IR) factor change scores and with mean change scores in women who underwent surgery (all p < .05). For NSA women, PISQ-IR scores correlated with PFDI-20, ISI scores, and with EPIQ question #35 (all p < .05). No items demonstrated differences between test and retest (all p ≥ .05), indicating stability over time. CONCLUSIONS: The PISQ-IR is a valid, reliable, and responsive measure of sexual function.

Giant urethral diverticulum -- repair augmented with bovine pericardium collagen matrix graft and tension-free vaginal tape.

A 44-year-old nulliparous woman was diagnosed with a giant urethral diverticulum. Surgical excision of the diverticulum was done. The urethral defect was closed with 2-0 vicryl sutures. A piece of bovine pericardium collagen matrix graft was placed over the fascial repair. A tension-free vaginal tape (TVT) sling was then placed over the graft. Concomitant anti-incontinence procedure can be combined with diverticulum repair.

Uterine retroversion for vaginoperineal reconstruction following resection of distal rectal tumors.

PURPOSE: Vaginal and perineal reconstruction following wide resection of locally invasive rectal cancer can be challenging. Various techniques have been reported, all of which contribute the additional morbidity inherent in tissue procurement. We present a technique applicable to nonhysterectomized patients who undergo posterior vaginal wall reconstruction with retroversion of the in situ uterus. METHODS: Four nonhysterectomized patients with recurrent rectal carcinoma and abdominoperineal resection with en bloc resection of the posterior vagina leaving a large defect necessitating reconstruction of the vagina, perineum, or both, have undergone posterior vaginal wall and perineal reconstruction with uterine retroversion into the posterior pelvis and fixation to the perineum. RESULTS: Satisfactory vaginoperineal reconstruction was achieved in all our patients at 3 months. In addition, patients are able to resume sexual activity after tissue re-epithelialization. CONCLUSION: Uterine retroversion is a viable option for vaginal and perineal reconstruction.

Minimally invasive treatment for female stress urinary incontinence (SUI): a review including TVT, TOT, and mini-sling.

Treatment for female stress urinary incontinence (SUI) has progressed rapidly over the past ten years in the search for less invasive methods to treat this disease. There have been over 100 procedures described in the literature to date to treat female SUI; however, only two procedures have stood the test of time and have adequate cure rates: the retropubic colposuspension (Burch, MMK) and the sling. The laparoscopic approach to minimize the Burch procedure was described in the 1990s, but the evolution of the retropubic tension-free vaginal tape sling (TVT) in the late 1990s revolutionized the treatment of female SUI. More recently, the transobturator technique (TOT) and the single-incision mini-sling have been reported in attempts to further reduce the risks of sling placement. The current chapter reviews the history of treatment of female SUI and the development of these newer, less-invasive techniques. The procedures themselves are described, the risks of mesh complications reviewed, and the literature reviewed for current data on the different approaches and procedures.

Transobturator slings for stress incontinence: using urodynamic parameters to predict outcomes.

The purpose of this study is to evaluate the ability of preoperative urodynamic urethral function parameters to predict the success rate of transobturator slings (TOS). Seventy women urodynamically diagnosed with stress incontinence with urethral hypermobility underwent a Monarc TOS (American Medical Systems, Minnetonka, USA). Postoperative continence status was correlated with preoperative urodynamic urethral function parameters. Mathematical modeling was used to determine whether urodynamic parameters can be used to predict postoperative continence. Average follow-up was 8.1 (6-12) months; 56 (80%) patients were continent based on a standardized stress test and subjective report. The median Valsalva leak point pressure at 150 cc (VLPP150) in the failures and successes was not different (p = 0.12). The median VLPP at cystometric capacity (VLPPcap) in the failures was 32 cmH2O compared to 71 cmH2O in the successes (p < 0.001). The maximum urethral closure pressure (MUCP) had a median of 20 cmH2O in the failures and 45 cmH2O in the successful patients (p < 0.001). No correlation existed between the degree of urethral hypermobility, as measured by the cotton swab test, and surgical success (p = 0.17). There was no correlation between level of preoperative urethral function and persistent overactive bladder symptoms, post-void residual, voids/day, and nocturia. Using a combined model, the cutoff values of VLPPcap > 60 cmH2O and MUCP > 40 cmH2O were the most predictive of surgical success, revealing a sensitivity of 83% (0.55, 0.95) and specificity of 79% (0.67, 0.88). A combination of urodynamic parameters can be used to predict continence rates after a TOS. A TOS should be used with caution in women with impaired urethral function.

Multicenter experience with the Monarc transobturator sling system to treat stress urinary incontinence.

This study was conducted to report on the safety and efficacy of a transobturator sling approach for treatment of urodynamic stress incontinence (USI). Women with urodynamic stress incontinence were offered a novel polypropylene mesh sling procedure, implanted beneath the lateral pubic rami rather than retropubically. Retrospective data were collected at three U.S. sites. Two hundred women with a mean age of 59 years (range 27-93) underwent the sling procedure. Mean follow-up was 21.5 weeks (range 3-43). Perioperative safety parameters are reported for all subjects and efficacy parameters for those who were followed up for 26 weeks or more. Among the subjects, 95.3% reported being continent or substantially continent (occasional leakage of small amounts, with protection not needed). Mean operative time was 13.8 min (range 7-34). Preoperatively, 75% wore pads, with 5.3% continuing to do so at 26 weeks. Pre-op urgency was reported by 62.7%, with 41.5% receiving medication. Urgency was reported postoperatively by 20.5% of patients, but only 13.6% were medicated for urgency. Urinary retention was identified in 0.9% at 26 weeks. Transobturator slings are highly effective for treatment of SUI, and may offer increased safety relative to traditional and tension-free retropubic slings.

Voiding dysfunction following TVT procedure.

The aim of the study was to assess the incidence of abnormal voiding in patients who had undergone tension-free vaginal tape (TVT) placement. Women who had undergone a TVT sling procedure for stress or mixed incontinence more than 3 months previously reported their voiding habits (frequency, urgency, nocturia, urinary stream quality and incontinence) over the previous 3 days. A pelvic examination and ultrasound postvoid residual (PVR) were performed. Normal voiding was classified as a PVR <100 ml, frequency of six or fewer voids per day and two or fewer per night, and a urinary stream considered normal by the patient. Subjects were classified as either 'normal' (group 1) or 'abnormal' (group 2) voiders. Demographic factors, pre-operative urodynamic testing and concomitant surgical procedures were compared between groups. From September 1999 to November 2000, 59 women underwent a TVT procedure. Two were excluded from analysis [cervical malignancy (1), interstitial cystitis (1)]. There were no healing abnormalities and no patients displayed a positive empty bladder stress test. Forty-two (74%) women were included in group 1 and 15 (26%) in group 2. Urinary continence was reported by 49 (86%): 93% in group 1 and 67% in group 2. Factors highly correlated with postoperative voiding dysfunction included abnormal preoperative uroflow pattern and configuration (P = 0.007), preoperative low peak flow rate <15 ml/s (P = 0.049), preoperative vault prolapse or enterocele (P = 0.001), concurrent vault suspension surgery (P = 0.03) and postoperative urinary tract infection (UTI) (P = 0.0006). Preoperative urinary retention (postvoid residual >100 ml) or detrusor instability, age and body mass index differences were not statistically significant. Multivariate analysis revealed that preoperative abnormal uroflow and postoperative UTI were related to group 2 (P = 0.02). Our conclusions were that the TVT sling procedure has success and voiding dysfunction rates similar to those of other proven anti-incontinence procedures. Various factors were shown to be associated with postoperative voiding difficulties. Tension-free placement of the tape may not prevent the development of post-operative voiding dysfunction.

Pelvic floor dysfunction management practice patterns: a survey of members of the International Urogynecological Association.

The authors report results of a survey of the practice patterns of International Urogynecological Association (IUGA) members in the management of urinary incontinence and pelvic organ prolapse. A questionnaire regarding current urogynecological clinical practice was developed by the Research and Development Committee of IUGA and mailed to all members of IUGA. Age, specialty, and geographic location factors were used for response comparisons. One hundred and fifty-two surveys (30%) were returned, 35% from North America, 51% from Europe/Australia/New Zealand, and 14% from elsewhere. The average age of respondents was 47.2 years (SD = 9.5), 89% were gynecologists and 11% were urologists. Overall, the procedures of choice for stress incontinence (SUI) were tension-free vaginal tape (TVT; 48.8%) and Burch colposuspension (44%). There were significant geographic variations noted. For SUI with low-pressure urethra/intrinsic sphincteric deficiency, TVT was used by 44.6% and suburethral sling by 32.3%. Various materials are used for suburethral slings, including autologous fascia (46.5%), Marlex mesh (27.8%) and cadaveric fascia lata (11.6%). Bulking agent injection therapy is used for ISD by 75% of respondents. Traditional reconstructive procedures are performed by the majority of respondents, including sacrospinous fixation (78%), abdominal sacrocolpopexy (77%), paravaginal repair (65%) and vaginal enterocele repair (93%); 6.5% use defecography in evaluating rectoceles and 44% use the POP-Q. Seventy-two per cent use urodynamic evaluation routinely in prolapse cases with no manifest SUI. Most IUGA members perform commonly accepted procedures for surgical therapy of urinary incontinence and genital prolapse. IUGA members do not frequently use anorectal physiology and fluoroscopic investigations to evaluate rectoceles prior to repair.

Gynecologic laparoscopy.

Laparoscopic techniques are slowly gaining acceptance in gynecologic oncology. Usage in early stage endometrial and ovarian cancer and in the evaluation of suspicious adnexal masses is increasing, but large prospective series have not been performed. Laparoscopic procedures carry a steep learning curve and there are a limited number of centers currently performing these procedures for oncologic indications. It seems clear, however, that for the well-selected patient, in experienced hands, laparoscopic procedures in gynecologic oncology offer many potential benefits.

Informed consent for obstetrics management: a urogynecologic perspective.

Obstetric management has been modified for conditions with acute, short-term consequences (i.e. breech presentation). It is timely to address those conditions related to the vaginal birth process which may have a delayed but significant negative impact on the mother's quality of life (i.e. urinary and fecal incontinence) but which may be reduced by selectively avoiding the vaginal birth process. The known possible consequences, and other associated risks and benefits, should be discussed with the pregnant patient and her spouse, in order to allow their input into the obstetric decision-making process and to individualize management. Urogynecologists are in a unique, no-conflict-of-interest position to further the acceptance of the concept of obstetrical informed consent. Cesarean delivery should not be seen as a failure of obstetric management, but rather as a safe and acceptable option to the vaginal delivery process, chosen after completing an informed decision-making process.

Prevalence and severity of urinary incontinence and pelvic genital prolapse in females with anal incontinence or rectal prolapse.

PURPOSE: The aim of this study was to determine the prevalence, severity, and associations between urinary incontinence and genital prolapse in females after surgery for fecal incontinence or rectal prolapse. METHODS: All patients who underwent surgery for fecal incontinence (Group I) or rectal prolapse (Group II) were compared with a control group of females (Group III) by 43 questions regarding demographic data, past medical and surgical history, and diagnosis and treatment of anal and urinary incontinence and genital and rectal prolapse. The type (stress, urge, and total) of urinary incontinence was determined and graded using an incontinence severity questionnaire (Individual Incontinence Impact Questionnaire). RESULTS: Overall response rate in the three groups of patients was 40.1 percent. The questionnaire was sent to 240 patients operated on for fecal incontinence or rectal prolapse, and 83 of them responded (34.5 percent). The patients were distributed into three groups: Group I consisted of 51 patients (mean age 56.7 +/- 14); Group II consisted of 32 patients (69.7 +/- 11); and Group III consisted of 40 patients (60.5 +/- 16). The prevalence of urinary incontinence in Group I was 27 (54 percent), in Group II was 21 (65.6 percent), and Group III was 12 patients (30 percent; P = 0.003). Genital prolapse was present in 9 (17.6 percent), 11 (34.3 percent), and 5 patients (12.5 percent), respectively (P = 0.03). The prevalence of coexistent urinary incontinence and genital prolapse in both study groups was 22.8 percent (19 patients). There were no statistically significant differences between Groups I and II relative to prevalence, type, and severity of urinary incontinence and genital prolapse, but there were significant differences between the two study groups and the control group. Of the patients in the study group, 67 percent had urinary incontinence before or at the time of surgery. CONCLUSION: There is a higher prevalence and severity of urinary incontinence and pelvic genital prolapse in females operated on for either fecal incontinence or rectal prolapse than in a control group. Therefore, female patients with fecal incontinence or rectal prolapse should be evaluated and treated by a multidisciplinary group of pelvic floor clinicians, including a gynecologist or urologist with special training in female pelvic floor dysfunction and a colorectal surgeon.

A short-term, multicenter, randomized double-blind dose titration study of the efficacy and anticholinergic side effects of transdermal compared to immediate release oral oxybutynin treatment of patients with urge urinary incontinence.

PURPOSE: We compared the short-term efficacy, safety and tolerability of transdermal versus oral oxybutynin in adults with urge urinary incontinence. MATERIALS AND METHODS: Volunteers with detrusor instability currently responding to oral immediate release oxybutynin were enrolled in our study. Those patients presenting with recurrence of incontinent symptoms after a 2-week washout underwent confirmatory cystometrogram with subsequent randomization to transdermal or oral treatment. Matching active and placebo medications included matrix patches applied twice weekly and capsules taken 2 or 3 times daily. Dose titration was based on anticholinergic symptoms. Outcome measures included comparison of baseline to 6 week changes in incontinence episodes on a 3 day urinary diary, a visual analog scale for efficacy and anticholinergic symptoms reported on a questionnaire. Safety monitoring included adverse events and skin tolerability of the transdermal system. RESULTS: A total of 76 patients were enrolled and 74 completed at least 4 weeks of treatment. Mean age in the transdermal and oral groups was 64 and 63 years, and 87% and 97% were female, respectively. Daily incontinent episodes decreased in the transdermal and oral groups (7.3 to 2.4 [66%] and 7.4 to 2.6 [72%], respectively, p = 0.39). The visual analog scale reduction in urinary leakage improved from washout in both groups (p <0.0001) with no difference between them (p = 0.9). Dry mouth occurred in significantly fewer patients in the transdermal (38%) compared with those in the oral group (94%, p <0.001). Of the patients in the transdermal group 67% noticed a reduction in dry mouth severity compared with previous oral treatment, and 90% had none or mild skin erythema. CONCLUSIONS: Transdermal delivery of oxybutynin resulted in comparable efficacy and a significantly improved anticholinergic side effect profile compared with oral administration in adults with urge urinary incontinence.

The treatment of nonobstructive urinary retention with high-frequency transvaginal electrical stimulation.

The usefulness of timed voiding, cholinergic medications, and high-frequency electrical stimulation in women with symptomatic urinary retention was evaluated. Results indicated that symptomatic urinary retention can be treated with behavioral modification and high-frequency electrical stimulation. Optimal results were found in younger women with stable bladders.

Effect of a urinary control insert on quality of life in incontinent women.

The aim of the study was to evaluate the efficacy, safety and effect on quality of life of the Reliance urinary control insert (Uromed Corp., Needham, MA) in women with genuine stress incontinence. Efficacy was evaluated at baseline and at the end of the 12-month study period by standardized pad-weight studies and by rating scales measuring acceptability, incontinence symptom improvement, ease of learning, comfort and time to habituation, recorded in diaries at monthly intervals in 63 women. The SF-36 Health Survey questionnaire was used to assess quality of life status at baseline without the device and after 12 months of device use. A significant decrease in urine loss at 12 months compared with baseline was shown by standardized pad-weight studies, with and without the device in situ. Urine loss was reduced by more than 80% in 91% of the 63 patients, and 79% were completely dry. Patient diaries showed significant improvement in control of leakage, comfort, and ease of device use during the study period. Short-term-36 Health Status data also indicated significant improvement in the physical functioning score at 12 months. Urinary tract infection and hematuria were the most common adverse effects. The Reliance urinary control insert is an efficacious and safe means of controlling genuine stress incontinence in women. The device was perceived as easy to use and comfortable for these 63 women, and resulted in improved quality of life.

A bladder-neck support prosthesis for women with stress and mixed incontinence.

OBJECTIVE: To evaluate the safety and efficacy of a bladder-neck support prosthesis, a vaginal device designed to support the bladder neck, in women with genuine stress and mixed incontinence. METHODS: For enrollment, incontinent women underwent a history, physical examination including cotton-swab test, urinalysis, postvoid residual urine, and multichannel urodynamic testing. Those with genuine stress incontinence or mixed incontinence and urethral hypermobility completed 7-day bladder diaries, the Incontinence Impact Questionnaire, and underwent standardized pad tests. They were fitted with a prosthesis and seen weekly to optimize fit and efficacy. At week 5, they underwent repeat evaluations with the best-fitting prosthesis in place. RESULTS: Seventy women were enrolled and 53 completed the 1-month study (29 genuine stress incontinence, 24 mixed incontinence). The mean ages were 50.4 years for genuine stress incontinence (range 24-76) and 55.7 years for mixed incontinence (range 30-88). A statistically significant reduction in incontinence was noted on pad testing (genuine stress incontinence, mean 46.6-16.6 g; mixed incontinence, mean 31.9-6.8 g) and in the bladder diary (genuine stress incontinence, mean 28.6-7.8 losses per week; mixed incontinence, mean 30.2-15 losses per week). Quality-of-life scores improved in both groups. With the device in place, urodynamic testing indicated normalization of urethral function without evidence of outflow obstruction. Subjects found the device comfortable, easy to use, and convenient. Side effects included five urinary tract infections and 23 cases of vaginal mucosal soreness or mild irritation. CONCLUSION: The bladder-neck support prosthesis significantly reduced involuntary urine loss in women with stress and mixed incontinence.

Clinical experience with a balloon-tipped urethral insert for stress urinary incontinence.

A balloon-tipped urethral insert for control of urinary incontinence in women has undergone clinical trials and has been accepted for clinical use by the U.S. Food and Drug Administration. On the basis of results of a multicenter clinical trial, it was concluded that the device provides a safe and effective option for management of genuine stress incontinence and mild mixed incontinence in women. This article reviews appropriate patient selection, education, and training to optimize patient acceptance and efficacy of this urinary control insert.

Introl bladder neck support prosthesis: international clinical experience.

The Introl bladder neck support prosthesis is a ring-shaped silastic device with two prongs located at one side such that when placed within the vaginal canal the bladder neck is suspended in a fashion similar to a surgical urethropexy. Since its initial description in 1988 the device has undergone clinical trials in the US and Japan, documenting its effectiveness in the treatment of stress and mixed incontinence in women. Introl is available for clinical use in the United States and has been well accepted by practicing clinicians. In Japan, exposure has occurred through clinical trials, which resulted in a high efficacy rate, i.e. 81% of the patients had either maximum benefit or benefit in the global usefulness rating, and 26% experienced minor adverse effects. This paper will summarize Introl clinical study findings and describe various clinical observations made during increased clinical usage.

Introl bladder neck support prosthesis: a nonsurgical urethropexy.

The Bladder Neck Support Prosthesis is a Silastic vaginal device designed to elevate and support the bladder neck and proximal urethra during stressful physical activities. It mimics the effects of a urethropexy on urethral function without resulting in urinary outflow obstruction. Recent clinical studies in women with stress and mixed incontinence have demonstrated significant objective reductions in involuntary urine loss and high subjective satisfaction ratings.

Effectiveness of a urinary control insert in the management of stress urinary incontinence: early results of a multicenter study.

OBJECTIVES: The purpose of this study was to test the safety and effectiveness of a urethral insert for managing stress or mixed urinary incontinence. METHODS: We performed a prospective, multicenter study of 135 female patients who were treated for 4 months with the Reliance Urinary Control Insert. The effectiveness of the insert was measured objectively at the time of first use and after 4 months' use by standardized pad weight studies. Insert effectiveness was also measured by reports of symptom improvement during patient interviews and on patient diaries. Urine microscopy and culture were obtained monthly; cystoscopy and urodynamics were conducted at study entry and at 4 months. RESULTS: Significant improvement in involuntary urine loss was observed. Objective measurement of urine loss revealed that 80% of the patients were completely dry, and 95% of the patients achieved greater than an 80% decrease in urine loss. In addition, patients' perceptions of acceptability, incontinence symptom improvement, ease of learning, comfort, and time to habituation also showed improvements. Untoward events reported during the study included hematuria, bacteriuria, and bladder irritation. These events did not require significant medical intervention and did not result in any long-term clinical sequelae. CONCLUSIONS: These preliminary results indicate that the Reliance Urinary Control Insert may be a safe, effective, and well-tolerated alternative to other available methods for the management of stress or mixed incontinence in women. Additional long-term follow-up will be required to substantiate this conclusion.