A randomized trial of urodynamic testing before stress-incontinence surgery.

BACKGROUND: Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes. METHODS: We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of "much better" or "very much better" on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points. RESULTS: A total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, -0.3 percentage points; 95% confidence interval, -7.5 to 6.9), which was consistent with noninferiority. There were no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent urodynamic tests were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes. CONCLUSIONS: For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959.).

Urodynamic utilization in the adult spina bifida patient: An institutional review.

PURPOSE: To characterize common clinical indications for urodynamic, a bladder function test, in adults with spina bifida. METHODS: A retrospective chart review was performed for 215 patients seen in an adult multidisciplinary spina bifida clinic who were registered with the National Spina Bifida Patient Registry from October 2011 to October 2018. Descriptive statistics were used for statistical comparisons. RESULTS: A total of 52 of 215 patients developed a clinical indication for urodynamics. Of these, 71 (33%) patients (8 of whom underwent testing twice) had urodynamics performed, resulting in a total of 79 urodynamic study encounters that were analyzed. Thirty-four (43%) urodynamic testing cases were performed due to a symptomatic change in lower urinary tract function; 14 (18%) were due to declining renal function or concern for upper tract deterioration based on imaging. The data obtained from urodynamic investigation led to new recommendations for urinary tract management in 59 (75%) of the urodynamic studies performed. A total of 32 of the 90 (35%) recommendations made were surgical interventions and 30 (33%) were for a change in medical management. Interestingly, 8 of the 18 (44%) routine or baseline urodynamic tests performed led to new recommendations in urinary tract management. CONCLUSION: A total of 24%of patients in the multidisciplinary spina bifida clinic developed an indication for urodynamic testing over a 7-year period which resulted in new recommendations for urinary tract management in most. As more patients with spina bifida enter adulthood, the indications for urodynamic evaluation may become more defined, since the results often lead to alterations in bladder management.

Concomitant Anterior Repair, Preoperative Prolapse Severity, and Anatomic Prolapse Outcomes After Vaginal Apical Procedures.

OBJECTIVE: The aim of the study was to compare anterior and overall prolapse prevalence at 1 year in surgical participants with or without concomitant anterior repair (AR) at the time of sacrospinous ligament fixation (SSLF) or uterosacral ligament suspension (ULS). METHODS: This is a secondary analysis of two surgical trials; concomitant AR was performed at surgeon's discretion. Anterior anatomic success was defined as pelvic organ prolapse quantification of prolapse point Ba ≤0 and overall success was defined as pelvic organ prolapse quantification points Ba, Bp, and C ≤0 at 12 months. RESULTS: Sixty-three percent (441/701) of the participants underwent concomitant AR and were older, more often postmenopausal, had previous hysterectomy, and had higher-stage anterior, but not apical prolapse. Anterior anatomic success was marginally but statistically better in the combined group (SSLF and ULS) with concomitant AR (82% vs 80%, P = 0.03). In subanalyses, the improvement in anatomic support with AR was observed only in the SSLF subgroup (81% vs 73%, P = 0.02) and mostly in the SSLF subgroup with higher preoperative stage (74% vs 57%, P = 0.02). Anterior repair did not improve success rates in participants with lower-stage prolapse or undergoing ULS. Overall success rates were similar to anterior anatomic success rates. Participants with higher-stage preoperative anterior prolapse had significantly lower success rates. CONCLUSIONS: In the absence of clinical trial data, this analysis suggests an AR should be considered for women with higher-stage prolapse undergoing an SSLF. Preoperative prolapse severity is a strong predictor of poor anatomic outcomes with native tissue vaginal apical surgeries.

The development of a lifetime care model in comprehensive spina bifida care.

PURPOSE: To describe the development and implementation of the Children's of Alabama (COA) Spina Bifida (SB) Lifetime-Care-Model, including standardized care protocols and transition plan. METHODS: In 2010, members of the pediatric team at COA began to evaluate limitations in access to care for patients with SB at various stages of life. Through clinic surveys, observations, and caregiver report, a Lifetime-Care-Model was developed and implemented. Partnerships were made with adult medicine colleagues to create an interdisciplinary model at each stage. Since developing this program, it has evolved to include standardized care protocols. RESULTS: Since 2011, there have been 42 prenatal clinics; 114 families received counseling and prenatal care. Of these, 106 have delivered at our center and established care in our pediatric clinic. There are currently 474 patients in the pediatric and 218 in the adult clinics. CONCLUSIONS: Our institutional experience suggests that patients with SB benefit from continuity of care throughout their lifetime. This article describes early failures which led to an evolution in approach and implementation of a Lifetime-Care-Model which results in a smooth transition between all phases of life. We hope that other institutions may adapt and build upon it to create programs unique to their specific patient needs.

Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial.

BACKGROUND: Urgency urinary incontinence (UUI) is a chronic condition for which sacral neuromodulation (SNM) (InterStim/Medtronic) and onabotulinumtoxinA (BTX) (BotoxA/Allergan) are utilized. These therapies have not been compared over extended time. OBJECTIVE: To compare UUI episodes (UUIE) over 24 mo following SNM or BTX. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, open-label, randomized, extension trial (February 2012-July 2016) at nine US medical centers involving 386 women with ≥6 UUIE over 3 d inadequately managed by medications. Participants were clinical responders to treatment: ≥50% reduction in UUIEs after SNM placement or 1 mo post BTX. INTERVENTION: SNM (n=194) versus 200 U BTX (n=192). SNM reprogrammings occurred throughout the 24 mo. After 6 mo, two additional BTX injections were allowed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary outcome: change in mean daily UUIE over 24 mo. SECONDARY OUTCOMES: no UUIE, ≥75% and ≥50% UUIE reduction; Overactive Bladder Questionnaire Short Form; Urinary Distress Inventory short form; Incontinence Impact Questionnaire; Patient Global Impression of Improvement; Overactive Bladder Satisfaction of Treatment Questionnaire; and adverse events (AEs). Primary analysis used a linear mixed model. RESULTS AND LIMITATIONS: Outcome data were available for 260/298 (87%) clinical responders. No difference in decreased mean UUIE was found over 24 mo (-3.88 vs -3.50 episodes/d,95% confidence interval [CI]=-0.14-0.89; p=0.15), with no differences in UUI resolution, ≥75% or ≥50% UUIE reduction. BTX group maintained higher satisfaction (mean difference=-9.14, 95% CI=-14.38--3.90; p<0.001), treatment endorsement (mean difference=-12.16, 95% CI=-17.7--6.63; p<0.001) through 24 mo. Other secondary measures did not differ. Recurrent urinary tract infections (UTIs) were higher after BTX (24% vs 10%; p<0.01), 6% required intermittent catheterization post second injection. SNM revision and removals occurred in 3% and 9% patients, respectively. CONCLUSIONS: Both treatments offered sustainable UUI improvement, and higher BTX dosing had low clean intermittent catheterization rates, but with UTI risk. SNM revision/removal rates were low due to standardized lead placement with strict treatment response definitions. PATIENT SUMMARY: We compared a large group of US women with severe urgency urinary incontinence (UUI) who received sacral neuromodulation (InterStim) or onabotulinumtoxinA (Botox A) therapy during a 2-yr period. We found that both therapies had similar success in reducing UUI symptoms, and adverse events were low. However, women in the BotoxA group had higher satisfaction and endorsement with their treatment, but with a higher chance of a urinary tract infection. We conclude that both therapies offer sustained reduction in daily incontinence over 2 yr.

Predictors of permanent disability among adults with spinal dysraphism.

OBJECTIVE Predictors of permanent disability among individuals with spinal dysraphism are not well established. In this study, the authors examined potential risk factors for self-reported permanent disability among adults with spinal dysraphism. METHODS A total of 188 consecutive individuals undergoing follow-up in an adult spinal dysraphism clinic completed a standardized National Spina Bifida Patient Registry survey. Chi-square tests and logistic regression were used to assess bivariate relationships, while multivariate logistic regression was used to identify factors independently associated with self-identification as "permanently disabled." RESULTS A total of 106 (56.4%) adults with spina bifida identified themselves as permanently disabled. On multivariate analysis, relative to completion of primary and/or secondary school, completion of technical school (OR 0.01, 95% CI 0-0.40; p = 0.021), some college (OR 0.22, 95% CI 0.08-0.53; p < 0.001), college degree (OR 0.06, 95% CI 0.003-0.66; p = 0.019), and holding an advanced degree (OR 0.12, 95% CI 0.03-0.45; p = 0.002) were negatively associated with permanent disability. Relative to open myelomeningocele, diagnosis of closed spinal dysraphism was also negatively associated with permanent disability (OR 0.20, 95% CI 0.04-0.90; p = 0.036). Additionally, relative to no stool incontinence, stool incontinence occurring at least daily (OR 6.41, 95% CI 1.56-32.90; p = 0.009) or more than weekly (OR 3.43, 95% CI 1.10-11.89; p = 0.033) were both positively associated with permanent disability. There was a suggestion of a dose-response relationship with respect to the influence of educational achievement and frequency of stool incontinence on the likelihood of permanent disability. CONCLUSIONS The authors' findings suggest that level of education and degree of stool incontinence are the strongest predictors of permanent disability among adults with spinal dysraphism. These findings will be the basis of efforts to improve community engagement and to improve readiness for transition to adult care in a multidisciplinary pediatric spina bifida clinic.

Adherence to Oral Therapy for Urgency Urinary Incontinence: Results from the Anticholinergic Versus Botox Comparison (ABC) Trial.

OBJECTIVES: Medication adherence with urgency urinary incontinence (UUI) treatment is challenging and the best assessment methodology is uncertain. We sought to describe adherence with anticholinergic (AC) versus placebo (P) by comparing pill counts and MEMSCAP event data and to identify factors associated with adherence. METHODS: The randomized controlled AC versus Botox Comparison trial of women with moderate to severe idiopathic UUI included 126 participants initiating AC plus P bladder injection and 121 receiving P pills plus Botox injection. Adherence data on 243 participants (124 AC and 119 P) were calculated by pill count and MEMSCAP data for each 2-month interval during the 6-month study that allowed for dose escalation/drug change. Overall composite adherence estimates were calculated using the average of both methods and weighted by the duration of each 2-month interval. RESULTS: Treatment groups had no significant differences in dosing duration (P = 0.76) or mean adherence (AC, 83.3% [16.8] vs. P, 84.8% [13.8]). Only 53% of women met the dichotomous outcome of more than 80% adherence during all intervals. Correlation between adherence by pill counts versus MEMSCAP decreased over time with pill counts demonstrating higher adherence than MEMSCAP (r = 0.53, 0.50, and 0.36 for each 2-month interval). Lower adherence was associated with higher baseline incontinence severity and better UUI quality of life for the AC group and with current smoking status in both groups. CONCLUSIONS: Adherence using pill counts and MEMSCAP was reasonably correlated and similar in both the AC and P groups. In the AC group, higher baseline incontinence severity and better UUI Quality of Life were associated with decreased adherence. Smokers were less adherent.

Effects of concomitant surgeries during midurethral slings (MUS) on postoperative complications, voiding dysfunction, continence outcomes, and urodynamic variables.

OBJECTIVE: To determine whether concomitant surgeries affected outcomes in a randomized trial comparing retropubic midurethral sling (MUS) vs transobturator MUS. METHODS: Subjects (n = 597) were stratified into 4 groups based on type of concomitant surgeries: group I had anterior/apical with or without posterior repairs (n = 79, 13%); group II had posterior repairs or perineorrhaphy only (n = 38, 6%); group III had nonprolapse procedures (n = 34, 6%); and group IV had no concomitant surgeries (n = 446, 75%). Complication rates, voiding dysfunction, objective and subjective surgical failure rates, and changes in urodynamic values (postop minus preop) were assessed and compared in these 4 groups. RESULTS: There were no differences in complications, voiding dysfunction, and subjective failure outcomes between these 4 groups. Group I had lower odds ratio of objective surgical failure compared with group IV (OR 0.38, 95% CI 0.18-0.81, P = .05). The OR of failure of all patients undergoing concomitant surgeries (groups I-III) was lower than group IV (OR 0.57, 95% CI 0.35-0.95, P = .03). The change in Pdet@Qmax (from pressure-flow) was significantly higher in group III vs IV (P = .01). The change in Q(max.) (from uroflowmetry) was significantly less in groups I and II vs group IV (P = .046 and .04, respectively). CONCLUSION: Concomitant surgeries did not increase complications. Subjects who underwent certain concomitant surgeries had lower failure rates than those undergoing slings only. These data support safety and efficacy of performing concomitant surgery at the time of MUS.

Three-dimensional ultrasonography to assess long-term durability of periurethral collagen in women with stress urinary incontinence due to intrinsic sphincter deficiency.

OBJECTIVES: To investigate the natural history of periurethral collagen injection (PCI) over time using serial three-dimensional ultrasonography (3DUS) of the urethra as an objective measure. METHODS: Retrospective chart review was performed for all patients who underwent PCI between February 1999 and February 2003. All had been diagnosed with stress urinary incontinence due to intrinsic sphincter deficiency without urethral hypermobility, had follow-up data including two or more 3DUS scans within 1 year or more, and had undergone no additional PCIs (ie, remained clinically improved). The follow-up examinations included serial history, symptom and quality-of-life (QOL) questionnaires (Urogenital Distress Inventory, global QOL visual analog scale [scale of 0 to 10, with 0 = best]), physical examination, and 3DUS scans. The primary subjective and objective outcomes were the Urogenital Distress Inventory and QOL scores and the 3DUS-determined periurethral collagen volume and configuration, respectively. RESULTS: Of the 54 patients undergoing PCI during the accrual period, 20 had follow-up of 1 year or longer (mean 2.0, range 1 to 3.8). The mean 3DUS collagen volumes were not statistically different at baseline at a mean of 4 months after PCI (2.9 +/- 1.9 cm3) compared with at the last follow-up visit (2.7 +/- 1.9 cm3; P = 0.34). The volume retention rate was 97% +/- 33% of the baseline volume. The periurethral configuration was circumferential in 80% and asymmetric in 20%, and was maintained over time. The postinjection Urogenital Distress Inventory question 3 (stress urinary incontinence) and QOL scores were significantly improved compared with the pre-PCI evaluations with a mean of 2.4 +/- 0.8 versus 1.4 +/- 0.7 (P = 0.013) and 7.3 +/- 2.6 versus 3.5 +/- 2.5 (P = 0.001), respectively. CONCLUSIONS: This is the first study to demonstrate the long-term durability of PCI on serial 3DUS in association with improved continence and QOL using questionnaire analysis. This new knowledge provides a technical and therapeutic endpoint for PCI.

Changes in detrusor smooth muscle myosin heavy chain mRNA expression following spinal cord injury in the mouse.

AIMS: Smooth muscle myosin heavy chain (SMMHC) isoform composition has been shown to be developmentally regulated and to be associated with functional changes in smooth muscle activity. In this study, we sought to determine expression patterns of SMMHC isoforms in a murine model of spinal cord injury (SCI) and to compare these expression patterns to neurologic, cytometric, and morphometric findings. MATERIALS AND METHODS: Baseline cystometry was performed on adult, female mice followed by either thoracic spinal cord transection (SCI) or sham operation (Sham). At 1, 3, or 6 weeks postoperatively neurologic evaluation and cystometry were performed, bladders were harvested, and expression patterns of SMMHC isoforms (SM1 vs. SM2 and SMA vs. SMB) were assessed by RT-PCR. Morphometrics utilizing computer-assisted color image analysis was also performed on all bladders. RESULTS: There was a significant increase in bladder weight and capacity 1 week following SCI which normalized over time, however, morphometric analysis did not reveal an alteration in tissue composition amongst the three groups. One week following SCI, SM1 was predominantly expressed over SM2 and began to normalize at 3 weeks. This coincided with the emergence of reflex voiding and detrusor overactivity. SMA was expressed following SCI only, and the number of bladders found to express SMA decreased with increasing duration since SCI. CONCLUSIONS: Smooth muscle myosin heavy chain mRNA expression patterns appear to be affected by SCI. We believe the induction of SMA may be a factor in altered bladder function following injury.

UroLume stents: lessons learned.

PURPOSE: The UroLume (American Medical Systems, Minnetonka, Minnesota) endoprosthesis has been commercially available since 1990 and has been advocated for use in men with urethral stricture disease and detrusor-sphincter dyssynergia due to spinal cord injury. Despite reports of its success and ease of removal, we have noted management problems in several complex cases. MATERIALS AND METHODS: We retrospectively analyzed the outcome of 10 men who required several additional procedures or experienced complications following UroLume placement. RESULTS: Of the patients 4 had detrusor-sphincter dyssynergia and 6 had urethral stricture disease. All patients with detrusor-sphincter dyssynergia required hospitalization for management of urosepsis within 4 to 10 months of stent placement, and all 4 experienced stent migration requiring placement of a tandem stent (3), bladder neck resection (3) or sphincterotomy (1). Two men were in retention following placement of a second stent and required stent explantation. Of the other 6 men 2 had bulbar and 3 had membranous urethral disease, and 1 had a severe bladder neck contracture following radical retropubic prostatectomy. Strictures recurred within the stent lumen in all 6 men and/or adjacent to it in 3. At least 1 repeat procedure was required in all 6 men (within 6 months in 5), and 1 experienced significant bleeding during open explantation which required perineal urethrostomy. CONCLUSIONS: In our referral experience stent migration and recurrent stenosis were noted following UroLume insertion. Placement of a tandem stent was associated with urethral obstruction. In many cases these adverse outcomes may be secondary to improper patient selection. Therefore, judicious use of the UroLume stent and proper case selection are essential since stent removal is not always straightforward.

Management of intrinsic sphincteric deficiency in women.

PURPOSE: We reviewed treatment options for intrinsic sphincteric deficiency in women with an emphasis on safety and efficacy. MATERIALS AND METHODS: Using MEDLINE, we comprehensively reviewed literature relevant to management of intrinsic sphincteric deficiency. We focused on peer reviewed articles from 1995 through December 2001 with older articles included for historical purposes. RESULTS: Past and current treatment options for intrinsic sphincteric deficiency fall into the 3 categories of urethral bulking agents, slings and artificial urinary sphincter. The autologous fascial pubovaginal sling continues to be the gold standard but newer sling materials are promising. Less invasive therapies with acceptable efficacy and safety profiles are still needed. CONCLUSIONS: Improved understanding of the continence mechanism may lead to new and improved treatment modalities for intrinsic sphincteric deficiency. However, it will be impossible to compare these treatment options with past treatment unless long-term, randomized, multicenter trials with specific definitions of cure and failure are conducted.

Three-dimensional ultrasonography: an objective outcome tool to assess collagen distribution in women with stress urinary incontinence.

OBJECTIVES: To examine the distribution of periurethral collagen by three-dimensional ultrasonography (3D US) and to incorporate this technology into a practical treatment decision tree for women with stress urinary incontinence desiring collagen injection. METHODS: Forty-six women who received periurethral collagen injection were assessed with 3D US to document the position and volume of collagen around the urethra. Patients with a good clinical response were observed with serial 3D US scans. Women with no persistent improvement who showed a low volume or asymmetric distribution of collagen were offered repeat injections. When the patient had no improvement despite symmetric or circumferential distribution of collagen with good volume retention, another anti-incontinence treatment was recommended. Group 1 was composed of women who had a good clinical outcome and group 2 of those who did not. A statistical comparison between the two outcome groups was done to determine whether any particular distribution pattern was associated with an increased likelihood of clinical success. RESULTS: Of the 46 patients, 21 (46%) were satisfied with their continence after their last periurethral collagen injection, with a median follow-up of 14.0 months (range 2 months to 4.25 years). A significantly greater proportion of patients in group 1 had circumferentially distributed collagen on 3D US compared with those in group 2 (62% versus 20%, P = 0.006). CONCLUSIONS: Circumferential distribution of collagen around the urethra is associated with a higher likelihood of clinical success. The assessment of periurethral collagen by 3D US provides an affordable, noninvasive, objective outcome measure that may aid in treatment planning.