Mesh erosion following abdominal sacral colpopexy in the absence and presence of the cervical stump.

INTRODUCTION AND HYPOTHESIS: We compared the role of abdominal sacral colpopexy (ASCP) with concomitant supracervical hysterectomy to ASCP alone in patients with prior hysterectomy in the prevention of mesh erosion. MATERIALS AND METHODS: We performed a retrospective chart review of 277 consecutive patients who underwent ASCP with one surgeon. Patients were separated into two groups based on the presence of a uterus at the time of surgery. Group A comprised195 patients with a uterus who underwent ASCP and concomitant supracervical hysterectomy; group B comprised 82 patients with prior total hysterectomy who underwent ASCP. The outcome measures included peri- and postoperative findings, complications, and surgical success. Data were analyzed by t test and chi-square test using SPSS software. RESULTS: No significant difference was found between groups during surgery in terms of anesthesia type, total operative time, and estimated intraoperative blood loss. At mean postoperative follow-up of 7-8 months, there was no difference between groups in terms of de novo urinary symptoms, recurrent vaginal-wall prolapse, or dyspareunia and Pelvic Organ Prolapse Quantification (POP-Q) point C examination. Sling erosion was observed in four (4.2 %) patients in group A versus none in group B. Apical mesh erosion was diagnosed in one patient in group A (0.5 %) and two (2.4 %) patients in group B. These differences were not statistically significant. CONCLUSION: Concomitant supracervical hysterectomy with ASCP was associated with a low incidence of mesh erosion and had the same intraoperative course and postoperative outcome as ASCP with previous hysterectomy.

Long-term quality of life and pelvic floor dysfunction after bariatric surgery.

OBJECTIVE: To evaluate effects of bariatric surgery on pelvic floor mediated quality of life in morbidly obese women. STUDY DESIGN: Prospective cohort study of 44 women undergoing bariatric surgery. RESULTS: Thirty-six women gave data at baseline and at mean follow-up of 3.15 years following bariatric surgery. Although urinary impact questionnaire scores improved (-34.92, P = .0020), colorectal-anal impact questionnaire and pelvic organ prolapse impact questionnaire scores did not improve despite significant weight loss. Baseline female sexual function index scores were low (17.70 ± 8.38) and did not improve with weight loss (16.91 ± 9.75, P = .5832). Pelvic organ prolapse/urinary incontinence sexual questionnaire scores did improve (35.78 ± 6.06 preoperatively vs 38.22 ± 6.03 postoperatively, P = .0193). CONCLUSION: Bariatric surgery is associated with significant improvement in the impact of urinary incontinence on quality of life. Sexual function was poor, and improved only on the pelvic organ prolapse/urinary incontinence sexual questionnaire that evaluated urinary incontinence.

Magnetic resonance imaging of abdominal versus vaginal prolapse surgery with mesh.

INTRODUCTION AND HYPOTHESIS: We compared two surgical approaches in patients with symptomatic prolapse of the vaginal apex with normal controls by analyzing pelvic landmark relationships measured using magnetic resonance imaging (MRI) before and after surgery. METHODS: In this prospective multicenter pilot study involving 16 participants, nulliparous controls (n = 6) were compared with ten parous (3.0 ± 1.0) women with uterine apical prolapse equal to or greater than stage 2. Group A (n = 5) underwent abdominal sacral colpopexy with monofilament polypropylene mesh and group B (n = 5) with vaginal mesh kit repair (Total ProLift). Subtotal hysterectomy was performed in all group A and no group B women. All patients underwent preoperative and 3-month postoperative Pelvic Organ Prolapse Quantification (POP-Q) and dynamic MRI. Comparison of MRI pelvic angles and distances was performed and analyzed by Mann-Whitney rank sum test and chi-square test. RESULTS: Vaginal apical support is similar at 3 months for abdominal sacral colpopexy (ASCP) and ProLift by POP-Q examination and MRI analysis. In both treatment groups, the postoperative POP-Q point C and MRI parameters were similar to nulliparous controls at 3 months. CONCLUSIONS: Anatomic outcomes for ASCP compared with ProLift were similar at 3 months in terms of vaginal apical support by POP-Q and MRI analysis. Continued comparative analysis of postoperative support with objective imaging seems warranted.

Solifenacin for overactive bladder with incontinence: symptom bother and health-related quality of life outcomes.

BACKGROUND: Approximately one-third of patients with overactive bladder (OAB) experience incontinence, a bothersome symptom with a clear negative effect on quality of life. OBJECTIVE: To assess OAB patients' perceptions of improvements in symptom bother and quality of life after taking solifenacin under conditions reflecting day-to-day practice. METHODS: VOLT (the VESIcare Open-Label Trial) was a prospective, open-label study in patients with OAB (defined as urgency, urge urinary incontinence, daytime frequency, or nocturia for > or =3 mo) who were treated with flexibly dosed, once-daily solifenacin for 12 weeks. This study included subjects enrolled in VOLT who, at baseline, had urge incontinence and reported incontinence as their most bothersome symptom. All patients were started on solifenacin 5 mg/day; at week 4, the dosage could be increased to 10 mg/day and at week 8 could be maintained or decreased back to 5 mg/day. Efficacy was assessed by 3 independent patient-reported outcomes: the Patient Perception of Bladder Condition (PPBC) scale, a visual analog scale (VAS) for assessing individual symptoms, and the Overactive Bladder Questionnaire (OAB-q). RESULTS: Of the 2205 patients in the VOLT full analysis set, 1586 (71.9%) had urge incontinence at baseline, of which 582 (36.7%) reported incontinence as their most bothersome symptom. In this cohort, mean PPBC score at baseline was 4.6 (indicating moderate-to-severe problems) and at endpoint had decreased significantly to 2.9 (very minor to some minor problems; p < 0.001). At endpoint, 80.4% of patients achieved improvement in their PPBC score. These patients reported significant improvements from baseline in urinary urgency, urge incontinence, frequency, and nocturia on the VAS (p < 0.001) and all OAB-q domains (symptom severity, coping, concern, sleep, social, health-related quality of life) at endpoint (p < 0.001). CONCLUSIONS: Patients reporting urge incontinence as their most bothersome OAB symptom can be expected to demonstrate significant improvements in multiple patient-related outcomes following treatment with flexibly dosed solifenacin.

Symptom bother and health-related quality of life outcomes following solifenacin treatment for overactive bladder: the VESIcare Open-Label Trial (VOLT).

BACKGROUND: Most clinical trials designed to evaluate overactive bladder (OAB) syndrome treatments have focused on measuring micturition variables from bladder diaries. However, although diaries help physicians assess symptoms objectively, they lack information on patients' subjective experience of OAB symptoms and the effects of treatment. OBJECTIVE: The objective of this study was to assess patients' perceptions of improvements in symptom bother and health-related quality of life (HRQOL) with solifenacin succinate 5- and 10-mg treatments in patients with OAB. METHODS: VOLT (VESIcare Open-Label Trial) was a prospective, flexible-dosing trial performed at 207 centers in the United States. Ambulatory adult (aged > or = 18 years) men and women with an established diagnosis of OAB (urgency, urge urinary incontinence, frequency, and/or nocturia for > or = 3 months) and who provided a sterile urine sample received solifenacin QD for 12 weeks. Initially, all patients received 5 mg/d, with the option of adjustment to 10 mg/d at 4 and 8 weeks. Effectiveness was assessed using the Patient Perception of Bladder Condition (PPBC) scale, a visual analog scale (VAS) for the degree of bother caused by individual OAB symptoms, and the overactive bladder questionnaire (OAB-q). Assessments were performed at study initiation and study end or study termination. Adverse events (AEs) were assessed throughout. RESULTS: Patients (N = 2225) were enrolled between June 2004 and April 2005. Patients with baseline data (n = 2205) had a mean (SD) age of 59.7 (14.4) years; most patients were women (1813 [82.2%]) and white (1761 [79.9%]). Of the total patients enrolled, 1743 (78.3%) completed all 12 weeks of the study. After 12 weeks of solifenacin treatment, improvement was observed in the mean values of patient-reported perception of bladder condition. Significant change was observed on the PPBC scale from the mean baseline value to study end (4.4 vs 2.9; P < 0.001). All subscales of HRQOL significantly improved on the OAB-q score (mean changes, 14.7 to 29.6; all, P < 0.001). On the VAS, there was a significant reduction in the degree of bother associated with urgency, urge urinary incontinence, frequency, and/or nocturia (mean changes in VAS ratings, -36.7 to -41.8; all, P < 0.001 vs baseline). Solifenacin was well tolerated in most patients. Treatment-emergent AEs were reported by 1321 (59.4%) patients. Most reported AEs were anticholinergic in nature and of mild to moderate severity: dry mouth, 477 (21.4%); constipation, 295 (13.3%); headache, 76 (3.4%); blurred vision, 57 (2.6%); nausea, 39 (1.8%); dyspepsia, 34 (1.5%); and dry eye, 29 (1.3%). Two hundred sixteen (9.7%) patients discontinued treatment due to AEs. CONCLUSION: Flexibly dosed solifenacin 5 and 10 mg QD was associated with reductions in patient-reported OAB symptom bother and improvements in patients' perception of bladder condition and HRQOL.

Safety and tolerability of tolterodine for the treatment of overactive bladder in adults.

This article evaluates the safety and tolerability of tolterodine for the treatment of overactive bladder (OAB), which is defined as urinary urgency with or without urgency incontinence, usually with frequency and nocturia, but without infection or pathology. OAB affects tens of millions of people worldwide. Data are summarized from clinical trials and from postmarketing surveillance studies.

Urogynecologic conditions: urinary incontinence.

Urinary incontinence (UI), the leakage of urine, is a condition that frequently goes untreated. There are many different types of UI, including stress and urge UI, and the etiology is multifactorial. Diagnosis can be made with a pertinent history, including use of a questionnaire; a pelvic examination; and direct observation. Additional testing can include physical maneuvers to elicit stress leakage and urodynamic studies. Treatment ranges from pelvic floor exercise to surgical support of the pelvic floor for stress UI and, typically, behavioral therapy and/or pharmacotherapy, starting with antimuscarinic drugs, for urge UI.

Urogynecologic conditions: interstitial cystitis/painful bladder syndrome.

Interstitial cystitis, also known as painful bladder syndrome, is a debilitating condition. The diagnosis is difficult and often is one of exclusion. Cystoscopy is the best way to confirm the diagnosis, but treatment can be initiated based on symptoms alone. Most patients benefit from an array of different drugs, including pentosan polysulfate, amitriptyline, hydroxyzine, and cimetidine. These treatments must be tailored for each patient. If oral drugs are ineffective, intravesical therapy can be attempted with dimethyl sulfoxide, heparin, or an anesthetic therapeutic combination containing lidocaine. Fulguration typically is performed if Hunner ulcers are found on cystoscopy. Hydrodistention, sacral neuromodulation, and intradetrusor onabotulinumtoxinA are sometimes useful.

Urogynecologic conditions: pelvic organ prolapse.

Chronic pelvic pain is a commonly encountered condition that often is multifactorial. Etiologies include gynecologic, urologic, gastrointestinal, and neurologic conditions. Laboratory tests, imaging, and surgical intervention are not always helpful in identifying the etiology of pelvic pain. For appropriate management of this complex disease process, a detailed history and physical examination, and a multidisciplinary approach are needed. Pelvic pain may be caused by endometriosis, pelvic inflammatory disease, adenomyosis, interstitial cystitis/painful bladder syndrome, or other factors. Evaluation may include keeping a pain diary; laboratory tests, such as a pregnancy test, urinalysis, or tests for sexually transmitted infections; ultrasonography of abnormalities detected on physical examination; and laparoscopy. Specific first-line treatments include nonsteroidal anti-inflammatory drugs and oral contraceptives for endometriosis; progestins, gonadotropin-releasing hormone analogs, aromatase inhibitors, or hysterectomy for adenomyosis; and education, food avoidance, and behavioral modifications for interstitial cystitis/painful bladder syndrome. Surgical options include nerve transection procedures, laparoscopic uterosacral nerve ablation, and presacral neurectomy, although data on effectiveness are limited.

Urogynecologic conditions: chronic pelvic pain.

Immigration has brought millions of individuals into the United States over the past decade. The Centers for Disease Control and Prevention and the US Public Health Service are charged with ensuring that immigrants who enter do not pose a public health risk. Health examinations and immunization regimens are required for individuals wishing to live in the United States. Many immigrants and refugees are exposed to communicable diseases not routinely encountered in the United States These include helminthic infections, tuberculosis, malaria, and other infections. Zoonotic infections, such as influenza A, and novel coronavirus infections also are of increasing concern because of population mobility.

Recognition of occult bladder injury during the tension-free vaginal tape procedure.

OBJECTIVE: To identify signs and the etiology of occult bladder injury during the tension-free vaginal tape sling procedure. METHOD: The charts of 140 women who underwent a tension-free vaginal tape procedure were reviewed, and complications were tabulated and analyzed. The tension-free vaginal tape procedure was performed in six fresh-frozen pelves to demonstrate the mechanism of the occult bladder injury. RESULTS: Occult bladder injury was suspected when cystoscopy instillation fluid flowed from the plastic sheath that covers the prolene tape after the extraction of the tension-free vaginal tape trocar. Three of six cases of intraoperative bladder injury had occult bladder injury identified on repeat cystoscopic inspection. The bladder injury caused by the rough edge at the point of attachment of the tension-free vaginal tape to the trocar was reproducible in three of 12 tension-free vaginal tape applications in fresh-frozen pelves. Traction on the tension-free vaginal tape reapproximates the injured bladder edges and potentially promotes spontaneous healing. CONCLUSION: Bladder injuries may go unrecognized during a tension-free vaginal tape procedure. Continuous seepage of water through the prolene plastic sleeve is suggestive of occult bladder injury and requires repeat cystoscopy to identify the potential site of injury.

Benefit-risk assessment of tolterodine in the treatment of overactive bladder in adults.

Overactive bladder is associated with symptoms of urgency, with or without urge incontinence, usually with daytime frequency and nocturia in the absence of local pathological factors. Muscarinic receptor antagonists (antimuscarinics) are the first-line pharmacotherapy. Tolterodine, a competitive, nonselective antimuscarinic specifically developed for the treatment of overactive bladder, demonstrated tissue selectivity for the bladder over the parotid gland in an animal model. As of March 5, 2003, the immediate-release (IR) formulation had been approved in 72 countries and the extended-release (ER) formulation had been approved in 28 countries, and tolterodine had been administered to 5 million patients. This review evaluates the benefit-risk profile of tolterodine in the treatment of adults with overactive bladder, summarising clinical trial and postmarketing surveillance data. Tolterodine has been found to significantly reduce micturition frequency, urgency perception and the number of episodes of urge incontinence and increase the volume voided per micturition. Dry mouth, an antimuscarinic class effect, is the most commonly reported adverse effect but is mostly mild to moderate in severity. Serious adverse effects are reported infrequently. Based on summary and review of postmarketing surveillance and clinical trial safety data received by the market authorization holder and contained in the Periodic Safety Update Reports for tolterodine, several monitored serious events of the gastrointestinal tract (e.g. ileus or haemorrhage), nervous system (e.g. syncope, convulsions and memory disorders) and cardiovascular system (e.g. ventricular arrhythmia, atrial fibrillation, palpitations, bradycardia, transient ischaemic attacks and hypertension) were not considered related to tolterodine. QT or corrected QT (QTc) prolongation was not observed in any of the five cases of verified ventricular arrhythmia in patients administered tolterodine; there is insufficient evidence to indicate that tolterodine causes ventricular arrhythmia or extrasystoles or any specific type of cardiac rhythm abnormality. The safety profile of tolterodine is similar in patients aged > or =65 years and in younger adults. Clinically relevant drug interactions are limited to cytochrome P450 3A4 inhibitors, such as ketoconazole, and co-administration with such agents warrants a tolterodine dosage decrease. In addition, tolterodine IR 2mg twice daily is similar in efficacy to oxybutynin IR 5mg three times daily, and tolterodine ER 4 mg once daily is similar in efficacy to oxybutynin ER 10mg once daily. Dry mouth occurred less frequently with tolterodine than oxybutynin, and moderate to severe dry mouth occurred more than three times less frequently. Based on the low frequency of adverse events, the absence of unexpected adverse events and the very low frequency of serious adverse events, we conclude that tolterodine is a well tolerated treatment for overactive bladder in adults, in whom it should be considered as first-line therapy.

Current pharmacotherapeutic strategies for overactive bladder.

Overactive bladder (OAB) is a chronic, distressing condition characterised by symptoms of urgency (sudden overwhelming urge to urinate) and frequency (urinating more than eight times daily), with or without urge urinary incontinence (sudden involuntary loss of urine). It affects millions of people of all ages and both sexes world wide, with greater prevalence in women and the elderly. The treatment of OAB is aimed at reducing debilitating symptoms, which have a significant effect on all aspects of an individual's quality of life, including social, domestic, psychological, occupational, physical and sexual functioning. Anticholinergic agents are currently recommended as first-line therapy for OAB. Their use results in significant clinical improvement in patients, although a lack of selectivity for receptors in the bladder may lead to troublesome side effects, including dry mouth, blurred vision, somnolence, dizziness and constipation. Recent research efforts have focused on developing drugs with a reduced propensity for causing these problems. Of the available anticholinergic agents, oxybutynin and tolterodine are the most widely used to treat OAB. Studies directly comparing tolterodine immediate-release (IR) with oxybutynin IR have shown that the two agents have similar efficacy. However, tolterodine IR is significantly better tolerated, particularly with respect to the incidence and severity of dry mouth. An extended-release formulation of tolterodine (4 mg capsules) has recently been developed to allow for once-daily dosing. In addition to greater convenience, tolterodine extended-release has shown enhanced efficacy and tolerability compared with tolterodine IR.

Diagnosis and surgical treatment of stress urinary incontinence.

Stress urinary incontinence (SUI) is a major problem affecting more than 20% of the nation's female population, with increasing prevalence as our population continues to age. Incontinence places a great burden on individuals, and the economic effect is large. Stress urinary incontinence occurs when there is involuntary leakage of urine during coughing, laughing, sneezing, or physical activity. It can be diagnosed during physical examination and by using low-cost office diagnostics. Although nonsurgical treatments provide some benefit, surgical interventions have demonstrated superiority with respect to subjective and objective cure and better long-term improvement. Corrective surgeries for SUI can be grouped into four categories: 1) slings (midurethral slings and slings placed at the ureterovesical junction), 2) retropubic urethropexy, 3) urethral bulking agents, and 4) artificial sphincters. The success and failure of each approach needs to be assessed in the context of individual patients and their circumstances. Slings and retropubic urethropexy are considered first-line surgical options. Since the advent of minimally invasive retropubic midurethral slings such as the tension-free vaginal tape, transobturator tension-free vaginal tape, and single-incision sling, retropubic urethropexy have fallen out of favor. Warnings about mesh use may contribute to a resurgence of retropubic urethropexy procedures such as the Burch procedure. A Burch procedure should still be considered for patients who have an aversion to mesh or if they are undergoing concurrent abdominal approach surgery. Urethral bulking agents are usually reserved for patients with a fixed, nonmobile urethra who cannot tolerate an operative experience or have failed previous antiincontinence procedures. Artificial sphincters should be considered an operation of last resort.

Effect of fesoterodine 4 mg on bladder diary and patient-reported outcomes during the first week of treatment in subjects with overactive bladder.

OBJECTIVE: To assess the onset of efficacy of fesoterodine 4 mg versus placebo in subjects with overactive bladder (OAB) symptoms. RESEARCH DESIGN AND METHODS: Subjects who reported OAB symptoms for ≥ 3 months and recorded ≥ 8 micturitions and ≥ 1 urgency urinary incontinence (UUI) episode per 24 hours in 3-day baseline diaries were randomized to fesoterodine 4 mg, tolterodine extended release (ER) 4 mg, or placebo. This is an analysis of first week data from a 12-week, double-blind trial. ClinicalTrials.gov unique ID: NCT00444925. MAIN OUTCOME MEASURES: Baseline to week 1 changes in 3-day bladder diary variables, Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS) scores reported by subjects receiving fesoterodine 4 mg or placebo. RESULTS: By week 1, fesoterodine 4 mg (n = 679) was associated with significantly greater improvements compared with placebo (n = 334) in micturitions, urgency, severe urgency and UUI episodes, frequency-urgency sum, and MVV per 24 hours and 3-day diary-dry rate (all p < 0.05), but not nocturnal micturitions per 24 hours (p = 0.273). These differences were significant as early as day 5 of treatment (i.e., day 1 of the 3-day diary) for all diary endpoints except nocturnal micturitions and MVV. Changes in PPBC scores were significantly more favorable with fesoterodine 4 mg versus placebo (p = 0.0143); changes in UPS scores were not significantly different (p = 0.077). CONCLUSION: The results provide evidence that patients receiving fesoterodine 4 mg for their OAB symptoms may expect to experience a response as early as 1 week after initiating treatment. One limitation is that, although 65% of subjects had received treatment with antimuscarinics before the study, whether subjects were dissatisfied with previous treatment and reasons for dissatisfaction were not collected. This might affect the magnitude of outcome improvements. Also, it is not known whether the UPS is sensitive enough to detect treatment differences as early as week 1.

Solifenacin treatment for overactive bladder in black patients: patient-reported symptom bother and health-related quality of life outcomes.

OBJECTIVE: Health-related quality of life (HRQoL) data for black patients receiving overactive bladder (OAB) treatment have not been previously reported. This study presents patient-reported outcomes, measured by symptom bother and HRQoL, in black patients participating in an open-label study of solifenacin succinate. Results are presented, as are those from the full study population. METHODS: In the 12 week, VESIcare Open-Label Trial (VOLT), patients received solifenacin 5 mg or 10 mg once daily according to an individualized, flexible dosing regimen. A post-hoc analysis assessed solifenacin efficacy and safety in blacks (n = 274). Three patient derived indices served as study endpoints. The Patient Perception of Bladder Condition (PPBC) scale assessed overall symptom bother, a visual analog scale (VAS) recorded individual symptom bother, the Overactive Bladder Questionnaire (OAB-q) measured OAB related HRQoL. RESULTS: Blacks reported significant reductions in bladder related problems based on PPBC scores (p < 0.001) and improvements in all OAB-q subscales (symptom severity, coping, concern, sleep, social, and HRQoL; p < 0.001). Based on VAS ratings, significant improvements were reported for urinary urgency, urge incontinence, frequency, and nocturia (p < 0.001 for change from baseline). Although this study was not placebo-controlled and statistical comparisons were not made, results were similar in the full study population. In total, 46% of black patients experienced adverse events (mostly anticholinergic) and 7.6% discontinued treatment as a result. CONCLUSIONS: Solifenacin treatment was perceived as offering relief from symptom bother and improving HRQoL in the black cohort from VOLT. These results are similar to those in the full VOLT population.