Urodynamics in the evaluation of female LUTS: when are they helpful and how do we use them?

Urodynamics remains the test of choice to evaluate lower urinary tract symptoms in men and women. Best practices recommend that urodynamics be applied to answer a specific urodynamic question. Recent level 1 evidence shows that urodynamics is not necessary for the evaluation of pure clinical stress urinary incontinence. Urodynamics is also not needed before conservative treatment of overactive bladder. Urodynamics still has an important role in the evaluation of mixed urinary incontinence and voiding lower urinary tract symptoms. The information obtained assists the clinician in confirmation of the diagnosis, counseling the patient, and choosing treatment.

Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline.

PURPOSE: The purpose of this guideline is to provide a clinical framework for the diagnosis and treatment of non-neurogenic overactive bladder (OAB). MATERIALS AND METHODS: The primary source of evidence for this guideline is the systematic review and data extraction conducted as part of the Agency for Healthcare Research and Quality (AHRQ) Evidence Report/Technology Assessment Number 187 titled Treatment of Overactive Bladder in Women (2009). That report searched PubMed, MEDLINE®, EMBASE and CINAHL for English-language studies published from January 1966 to October 2008. The AUA conducted additional literature searches to capture treatments not covered in detail by the AHRQ report and relevant articles published between October 2008 and December 2011. The review yielded an evidence base of 151 treatment articles after application of inclusion/exclusion criteria. When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high), B (moderate) or C (low). Additional treatment information is provided as Clinical Principles and Expert Opinions when insufficient evidence existed. RESULTS: The evidence-based guideline statements are provided for diagnosis and overall management of the adult with OAB symptoms as well as for various treatments. The panel identified first through third line treatments as well as non-FDA approved, rarely applicable and treatments that should not be offered. CONCLUSIONS: The evidence-based statements are provided for diagnosis and overall management of OAB, as well as for the various treatments. Diagnosis and treatment methodologies can be expected to change as the evidence base grows and as new treatment strategies become obtainable.

Approach to management of iatrogenic foreign bodies of the lower urinary tract following reconstructive pelvic surgery.

PURPOSE: Evolving techniques and materials for pelvic reconstruction have resulted in corresponding increases in the risk of iatrogenic foreign bodies in the lower urinary tract and vagina. We review the presentation, management and outcomes of iatrogenic foreign bodies in the female lower urinary tract and vagina. MATERIALS AND METHODS: We performed a retrospective review of the records of all women undergoing removal of lower urinary tract foreign bodies during a 9-year period. All patients underwent a structured evaluation including history, physical examination, ancillary testing as indicated and subjective symptom appraisal. RESULTS: A total of 85 women were identified, of whom 48 had vaginal, 40 had lower urinary tract, and 3 had concomitant vaginal and lower urinary tract excision of foreign material. Of the lower urinary tract cases the foreign body was located in the urethra in 12, bladder neck in 10, bladder wall in 18 and trigone in 3, while the remainder of the cases was vaginal in location. Aggressive surgical management aimed at removal or debulking of the exposed foreign body necessitated cystorrhaphy/partial cystectomy (20), urethroplasty (18) and fistula repair (3). Of the patients with vaginal excision 36 (75%) reported cure (of presenting symptoms), 10 (20.8%) reported improvement and 2 were unavailable for followup. Of the patients with lower urinary tract excision 21 (52.5%) reported cure, 14 (35%) indicated improvement and 5 were unavailable for followup. CONCLUSIONS: In a complex group of women with vaginal or lower urinary tract foreign body extrusion, aggressive operative management resulted in high rates of subjective patient cure. Adequate assessment of newer reconstructive technologies is critical to assess the full impact of these complications.

Assessing the surgical skills of urology residents after preurology general surgery training: the surgical skills learning needs of new urology residents.

OBJECTIVE: Resident work-hour restrictions and a reduction in general surgery training have impacted urologic training. We sought to assess the educational needs of urology residents after preurology training in general surgery to compare self-reported outcomes to those of supervising faculty and to determine which aspects of preurology training have an impact on those needs. DESIGN: A survey was distributed electronically to urology residents and faculty of Accreditation Council for Graduate Medical Education (ACGME) residency programs. Residents evaluated 11 surgical skills with regard to their importance to subsequent urology training and their self-assessed proficiency with those skills. Faculty members evaluated the same skills with regard to their importance and their residents' proficiency with those skills. All individuals evaluated 11 general surgery rotations with regard to their importance to later urology training. The responses were analyzed using the paired Wilcoxon test, and faculty responses were compared with resident responses using the Fisher exact test and the χ(2)-test. SETTING: Urologic surgery residency programs in the United States. PARTICIPANTS: There were 305 resident responses and 58 faculty responses. RESULTS: For each surgical skill, residents perceived skills as being more important than their self-assessed proficiency with those skills (p < 0.001). Resident and faculty assessments of surgical skills and of general surgery rotations were similar. More time spent in general surgery training was associated with increased self-assessed proficiency. No difference was found between resident and faculty assessment of global surgical skills (p = 0.76) or general surgery rotation importance (p = 0.87). CONCLUSIONS: A discrepancy was determined between urology residents' perceptions of the importance of surgical skills and their proficiency with those skills. The duration of general surgery training might have an impact on self-assessed skills proficiency. Concordance was demonstrated between resident and faculty perceptions of residents' surgical skills and of general surgery rotations.

Cystocele repair with interpositional grafting.

This article discusses a systematic approach to the repair of cystoceles using interposition grafting. Surgeons' opinions vary regarding which graft is most appropriate as there are several varieties for mesh interposition. High-grade cystocele repair using the porcine dermis interposition graft is successful and associated with few complications. Cystocele repair is typically low grade and does not require additional surgery.

Female urethral diverticula.

Surgical excision is the definitive treatment of urethral diverticulum (UD) and the only reasonable surgical option for treating midurethral and proximal UD. Success depends on proper staging by determining the extent and number of diverticula and attention to surgical technique. This article offers practical guidance in adjusting technique to accommodate commonly encountered difficult clinical scenarios.

Long-term safety, tolerability, and efficacy of fesoterodine treatment in men and women with overactive bladder symptoms.

OBJECTIVE: To evaluate long-term safety, tolerability, and efficacy of fesoterodine for men and women with overactive bladder (OAB) symptoms. RESEARCH DESIGN AND METHODS: This was a post hoc analysis of data pooled from two open-label extensions (NCT00220402, NCT00220376) of double-blind studies. All subjects began open-label treatment with fesoterodine 8 mg once daily, with voluntary dose reduction to 4 mg and re-escalation to 8 mg each permitted once annually. Maximum allowable duration of open-label treatment ranged from 24 to 36 months. MAIN OUTCOME MEASURES: Safety and discontinuations were assessed throughout treatment; subject-reported treatment tolerability and 3-day bladder diaries were evaluated at open-label baseline and months 1, 4, 8, 12, and 24. RESULTS: A total of 185 men and 705 women enrolled; 83 men (45%) and 356 women (50%) continued open-label treatment for ≥ 24 months. Most men (84%) and women (75%) remained on fesoterodine 8 mg throughout open-label treatment. No new or unexpected safety signals were observed. Dry mouth was the most common treatment-emergent adverse event (men, 24%; women, 32%), rates of discontinuation due to dry mouth were low (men, 1%; women, 2%). Most men and women (≥ 91%) reported at least 'good' tolerance. For men and women, statistically significant improvements in urgency urinary incontinence episodes, micturitions, urgency episodes, and mean voided volume per micturition achieved between double-blind baseline and open-label baseline were sustained or further improved through month 24; significant improvements in most OAB symptoms were observed between double-blind baseline and month 24 when subjects were stratified by double-blind treatment (placebo, tolterodine extended release 4 mg, fesoterodine 4 mg, fesoterodine 8 mg). Limitations include the lack of a placebo control and that subjects completing double-blind treatment may have been more likely to tolerate or respond to long-term fesoterodine treatment. CONCLUSIONS: Long-term fesoterodine treatment was well tolerated and associated with sustained improvements in OAB symptoms in men and women.

Safety and efficacy of sling for persistent stress urinary incontinence after bulking injection.

OBJECTIVES: To evaluate the impact of injectable agents on subsequent incontinence surgery outcomes to assess safety and efficacy of this treatment combination. Periurethral bulking agents are a minimally invasive treatment option for stress urinary incontinence (SUI), but often lack durability necessitating further surgical intervention. METHODS: Retrospective review of 43 patients with SUI following bulking agent who underwent subsequent sling placement from November 2000 to September 2009 were evaluated for demographics, symptoms, urodynamics (UDS), bulking agent characteristics, concomitant procedures, pad requirements per day (PPD), subjective outcomes, and complications. RESULTS: Mean patient age was 67 years, with mean follow-up of 37.3 months. All demonstrated SUI, and mixed urinary incontinence (MUI) was noted in 81.4%. Almost half (48.8%) had undergone a prior antiincontinence procedure. Mean number of injections was 3. After a bulking injection, 25 autologous fascia pubovaginal slings, 13 midurethral slings, and 5 biological pubovaginal slings were placed. Concomitant pelvic surgery was performed in 37.2%. Postoperatively, mean PPD decreased from 5.3 to 0.65, with a 60.5% subjective cure rate (no pads or leakage under any circumstances). No association was seen between number or type of injection, or type of sling with regards to patient outcomes. Results were significantly related to concomitant surgery (P = .007). SUI recurred in 8 patients (18.6%), which was not statistically associated with other parameters. Complications included urinary retention (8 patients) de novo urgency (1 patient), UTI (4 patients), abdominal wound infection (3 patients), and cystotomy (1 patient). CONCLUSIONS: Prior treatment with bulking agents does not appear to negatively affect outcomes for future antiincontinence surgery in our patient population.

Mixed incontinence and cystocele: postoperative urge symptoms are not predicted by preoperative urodynamics.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) frequently presents with urinary incontinence, either urge (UUI), stress (SUI), or mixed (MUI). We sought to determine the effect of high-grade prolapse repair on MUI. METHODS: A retrospective review was performed for 111 patients with anterior POP repair and sling over 4 years. RESULTS: Sixty patients (54%) presented symptomatically with MUI, 25% with SUI, and 9% with UUI, 12% asymptomatic. Occult SUI was found in 21% (UUI plus asymptomatic). Success was seen for SUI in 92% and for POP in 89%. Urge symptoms were present in 63% pre-op and 30% post-op. MUI patients were significantly more likely to experience post-op urgency (p = 0.033). Detrusor overactivity (DO) was seen in 22 MUI patients, but was not predictive of post-op urgency (p = 0.91). CONCLUSIONS: Cystocele patients with MUI are at significant risk for postoperative urge symptoms regardless of DO, and counseling regarding persistent urgency is imperative.

Five-year cost analysis of intra-detrusor injection of botulinum toxin type A and augmentation cystoplasty for refractory neurogenic detrusor overactivity.

PURPOSE: Treatment options for antimuscarinic refractory neurogenic detrusor overactivity (NDO) are botulinum toxin type A injections (BTX-A) and augmentation cystoplasty (AC). We estimated initial and cumulative 5-year costs of these treatments. MATERIALS AND METHODS: Base case is an individual with antimuscarinic refractory NDO and decreased bladder compliance. Primary analysis is from the health care payor perspective. Model probabilities and ranges were derived from literature and chart review. Reimbursements were derived from the average of insurance carriers. Complication cost calculations were based on standard practice. Decision-analysis model was made with TreeAge Pro Healthcare 2009 Software, Inc. and rolled back for cost calculation. One-way sensitivity analysis was performed on all variables, and two-way sensitivity analyses were based on these results. RESULTS: Average reimbursement for one BTX-A injection and AC was $2,946.83 and $25,041.53, respectively. BTX-A treatment was less expensive over 5 years, costing $28,065. The model was only sensitive within a reasonable clinical range for Botox durability. BTX-A was more cost-effective over 5 years if the effect lasted for >5.1 months. The model was based on an AC complication rate of 40%. If the PAC complication rate<14%, AC was cheaper over 5 years. The model was sensitive to surgeons costs of BTX-A ($3,027) and facility costs of BTX-A ($1,004) and AC ($17,100). CONCLUSIONS: This is the first cost analysis of BTX-A and AC. BTX-A is cheaper at durations>5.1 months and AC was cheaper when the cost of BTX-A increases or the AC complication rate dropped below 14%.

Effects of tolterodine ER on patient-reported outcomes in sexually active women with overactive bladder and urgency urinary incontinence.

OBJECTIVE: To assess the effects of tolterodine extended release (ER) on patient-reported outcomes (PROs) in sexually active women with overactive bladder (OAB) and urgency urinary incontinence (UUI). RESEARCH DESIGN AND METHODS: This multicenter, double-blind, placebo controlled trial included 411 women aged > or =18 years reporting OAB symptoms for > or =3 months; > or =8 micturitions per 24 hours (including > or =0.6 UUI episodes and > or =3 OAB micturitions) in 5-day bladder diaries at baseline, and being in a sexually active relationship for > or =6 months. Subjects randomized to placebo or tolterodine ER completed validated OAB- or incontinence-specific questionnaires, including the Patient Perception of Bladder Condition (PPBC), Overactive Bladder Questionnaire (OAB-q), Urgency Perception Scale (UPS), and the Incontinence Impact Questionnaire (IIQ) at baseline and week 12, as well as the Perception of Treatment Benefit and Treatment Satisfaction questions at week 12. This study is registered with ClinicalTrials.Gov (identifier: NCT00143481). RESULTS: The mean age of enrolled women was approximately 48 years. Compared with placebo, the tolterodine ER group reported significant baseline to week 12 improvements in PPBC responses (p = 0.0048); OAB-q Symptom Bother, total Health-Related Quality of Life (HRQL), and HRQL domain scores (all p < 0.05); IIQ Emotional Health domain scores (p < 0.05); proportions of subjects reporting treatment benefit (79 vs. 54%; p < 0.0001) and satisfaction (78 vs. 59%; p < 0.0001). Improvements on the UPS were not significantly different. CONCLUSIONS: Tolterodine ER treatment was associated with improvements in multiple OAB- and incontinence-specific PROs in a sexually active, relatively young, and racially diverse population of women. The findings provide clinicians with new insights into the impact of OAB and its treatment on HRQL in this population, which has been underrepresented in previous OAB studies. Study limitations include a potential underestimation of the impact of OAB symptoms resulting from the exclusion of women who may not be sexually active because of their urinary symptoms.

How to use an article about therapy.

PURPOSE: Most surgical interventions have inherent benefits and associated risks. Before implementing a new therapy we should ascertain the benefits and risks of the therapy and assure ourselves that the resources consumed in the intervention will not be exorbitant. MATERIALS AND METHODS: We suggest a 3-step approach to using an article from the urological literature to guide patient care. We recommend asking whether the study can provide valid results, reviewing the results and considering how the results can be applied to patient care. RESULTS: Key methodological characteristics that have an impact on the validity of a surgical trial include randomization, allocation concealment, stratification, blinding, completeness of followup and intent to treat analysis. To the extent that the quality is poor inferences from this study are weakened. However, if its quality is acceptable, one must determine the range within which the true treatment effect lies (95% CI). One must then consider whether this result can be generalized to a patient and whether the investigators have provided information about all clinically important outcomes. It is then necessary to compare the relative benefits of the intervention with its risks. If one perceives that the benefits outweigh the risks, the intervention may be of use to the patient. CONCLUSIONS: Given the time constraints of busy urological practices and training programs, applying this analysis to every relevant article would be challenging. However, the basics of this process are essentially what we all do hundreds of times each week when treating patients. Making this process explicit with guidelines to assess the strength of the available evidence will serve to improve patient care. It will also allow us to defend therapeutic interventions based on available evidence and not on anecdote.

Diagnosis and management of outlet obstruction in the female.

PURPOSE OF REVIEW: Bladder outlet obstruction in women results from a remarkable diversity of underlying pathologies. The potential array of presenting symptoms often makes the diagnosis complex, although the condition is predominantly assessed by the urologist as a consequence of incontinence surgery. Recent advances in the diagnosis and management of outlet obstruction in women and the impact on clinical practice are outlined. Recent trials have defined the importance of early intervention for successful resolution of acute, surgically induced obstruction in women. Methods of management for persistent symptoms due to induced obstruction have been reported that render improved symptomatic response. RECENT FINDINGS: We present strategies for diagnostic evaluation of bladder outlet obstruction, including history taking and physical exam, as well as a review of appropriate imaging modalities and utilization of videourodynamics. Common conditions resulting in bladder outlet obstruction are discussed along with disease-specific treatment strategies. Diagnostic definitions of obstruction have evolved and improved nomograms have been developed to define study populations. SUMMARY: Recent data have underscored the need for a structured management algorithm. Areas of future research should focus on understanding the natural history of outlet obstruction in women, especially when it occurs in women who have undergone surgery for incontinence and have developed obstruction. Lower urinary tract response to acute obstruction and method of optimal management remain to be defined.

Histologic comparison of pubovaginal sling graft materials: a comparative study.

OBJECTIVES: Little is known about the host response to the various biologic and synthetic graft materials used as substitutes for autologous fascia. We investigated the host response to sling graft materials in humans. METHODS: A total of 24 women undergoing sling revision had a portion of the graft material removed for comparative analysis. At exploration, the degree of graft preservation (integrity), encapsulation, infection, and fibrosis was quantified. A histopathologic analysis was performed by systematically examining each specimen for the inflammatory response, neovascularity, and host fibroblast infiltration. RESULTS: A total of 24 grafts were explanted at 2-34 months after implantation. The indications for removal were a lack of sling efficacy in 2, urinary retention in 9, and sling obstruction in 13. The types of graft material were polypropylene mesh (PPM) in 10, autologous fascia in 5, porcine dermis in 4, cadaveric dermis in 3, and cadaveric fascia in 2. No graft degradation had occurred in PPM material. Autologous and cadaveric fascia had the most demonstrable graft degradation. No encapsulation had occurred with autologous fascia or PPM. The porcine dermis was the most encapsulated. No host infiltration had occurred with the encapsulated porcine grafts, and only peripheral infiltration of fibroblasts had occurred in the cadaveric grafts. The PPM grafts had the greatest number of fibroblasts throughout the entire graft. Neovascularity was the most prevalent in mesh and was also present in the autologous fascia. Giant cells were seen in two mesh and two porcine grafts. CONCLUSIONS: The results of our study have shown that porcine dermis has the potential to encapsulate. The degree of host tissue infiltration was greatest with PPM, and no degradation of the mesh material had occurred with time.

Removal of transobturator midurethral sling for refractory thigh pain.

Polypropylene midurethral slings have become the most common surgical procedure for the treatment of stress urinary incontinence. The efficacy has been well established through prospective and systematic evaluation. Transobturator midurethral slings have demonstrated comparable efficacy relative to the retropubic approach with the potential to minimize the morbidity associated with retropubic needle passage. We present a case of recalcitrant medial thigh pain after transobturator midurethral sling placement that ultimately required medial thigh/transobturator exploration and sling excision.

The evolution of obstruction induced overactive bladder symptoms following urethrolysis for female bladder outlet obstruction.

PURPOSE: Bladder outlet obstruction following stress incontinence surgery may present as a spectrum of lower urinary tract symptoms. We evaluated the prevalence and impact of persistent overactive bladder symptoms following urethrolysis for iatrogenic bladder outlet obstruction. MATERIALS AND METHODS: In a retrospective review we identified 40 patients who underwent urethrolysis. All patients underwent a standardized urological evaluation. Patients identified with genitourinary erosion, neurogenic bladder dysfunction and preexisting overactive bladder were excluded. Urethrolysis outcomes were determined by subjective bladder symptoms and objective parameters. Validated questionnaires were completed to assess symptom bother, patient satisfaction and quality of life. Statistical analyses were performed using Stata, version 9.0. RESULTS: A total of 40 patients were included in the study with a mean +/- SD followup of 13 +/- 11 months (range 3 to 38). Of the patients 34 patients presented with obstructive symptoms, while 36 had overactive bladder symptoms. Obstructive symptoms resolved in 28 of the 34 patients (82%), while overactive bladder symptoms resolved completely in only 12 (35%) and they were significantly improved in 4 (12%). Overall 20 patients (56%) were on antimuscarinics for refractory overactive bladder and 8 ultimately required sacral neuromodulation. Pre-urethrolysis detrusor overactivity was more likely in patients with persistent overactive bladder symptoms than in those in whom overactive bladder symptoms resolved (70% vs 38%). Patients with persistent overactive bladder had significantly greater symptom severity/bother, and decreased perception of improvement and quality of life following urethrolysis. CONCLUSIONS: Following urethrolysis overactive bladder symptoms may remain refractory in 50% or greater of patients, which has a negative impact on quality of life and the impression of improvement after surgery. Detrusor overactivity demonstrated preoperatively may be useful for predicting who may have persistent overactive bladder symptoms despite an effective urethrolysis procedure.

Refractory overactive bladder after urethrolysis for bladder outlet obstruction: management with sacral neuromodulation.

Refractory overactive bladder (OAB) after urethrolysis for iatrogenic bladder outlet obstruction (BOO) is a clinical dilemma without established guidelines for management. We sought to evaluate the efficacy of sacral neuromodulation (SNM) in the management of this complex patient population. Retrospective review identified eight patients who underwent SNM secondary to refractory OAB after urethrolysis or sling take-down. SNM was performed with the Interstim device (Medtronic, Minneapolis) using a two-stage implant technique. SNM outcomes were determined subjectively during follow-up. Validated questionnaires were completed to assess symptom bother, patient satisfaction, and quality of life. Statistical analyses were conducted using Stata version 9.0. Six patients had a favorable response to SNM during test stimulation and underwent implantation of the implantable pulse generator (IPG). With follow-up of 15.7 +/- 11.1 months (6-34), all patients significantly improved, with three patients being dry and three patients having one to two urgency incontinence episodes per week. Patient-reported outcomes indicated that patients perceived themselves as very much improved (3) or much improved (3) after SNM, while those failing test stimulation perceived no change. Quality of life and symptom bother were significantly better in SNM responders vs nonresponders. SNM appears to be an effective and viable treatment option in this complex patient population. Further work is needed to determine clinical factors predictive of outcome and durability of response.