Phase 3
N=143
Behavioral Treatment of Overactive Bladder in Men
Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT01187498 ↗Enrolled (actual)
143
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: 24-hour Voiding Frequency — 9.1; 9.5 voids per 24-hour day — p=.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Behavioral training (Behavioral); Oxybutynin chloride, extended-release (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Male
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 24-hour Voiding Frequency |
9.1; 9.5 | .001 sig |
| SECONDARY Change in Nocturia Frequency |
-0.70; -.32 | .05 |
| SECONDARY Change in Urgency Severity |
.04; -.15 | .05 |
| SECONDARY Percent Change in Frequency of Urge Incontinence |
87.2; 75.6 | .33 |
| SECONDARY Change on American Urological Association (AUA) Symptom Index |
3.4; 3.2 | .84 |
| SECONDARY Patient Global Perception of Improvement (GPI) |
23; 18; 30; 34; 10; 7 | .69 |
| SECONDARY Patient Satisfaction |
36; 25; 25; 33; 2; 2 | .16 |
| SECONDARY Patient Global Rating of Activity Restriction |
29; 31; 19; 15; 11; 13 | .56 |
| SECONDARY Patient Report of Symptom Distress |
19; 17; 30; 35; 14; 7 | .65 |
| SECONDARY Patient Global Rating of Bothersomeness of Side Effects |
23; 11; 16; 13; 16; 19 | .01 sig |
| SECONDARY Patient Desire for Alternate Treatment |
18; 30 | .02 sig |
Summary
The primary purpose of this project is to evaluate the effectiveness of behavioral treatment compared to standard drug therapy for symptoms of OAB in male veterans.
Eligibility Criteria
Inclusion Criteria
- Male
- Community-dwelling
- Veteran
- Self-reported urgency
- Self-reported frequent urination
- Mean of > 8 voids per 24-hour day on bladder diary
- Able to come to clinic
Exclusion Criteria
- Urologic surgery in the past 6 months
- Nonambulatory (unless has independent transfer skills)
- Flow rate 250mL at baseline and > 150mL after run-in (on bladder ultrasound)
- Continual leakage
- Urinary tract infection (growth of > 100,000 colonies per ml of a urinary pathogen on urine culture). May be reconsidered after treatment and negative culture.
- Fecal impaction
- Poorly controlled diabetes (glycosylated hemoglobin >9 within last 3 months)
- Hematuria on microscopic examination in the absence of infection
- Any unstable medical condition (particularly: decompensated congestive heart failure, malignant arrhythmias, unstable angina)
-- Impaired mental status (< 24 on Folstein's Mini-Mental State Exam)
- Narrow angle glaucoma
- Gastric retention (by medical history)
- Hypersensitivity to tamsulosin or oxybutynin
- Current use of anticholinergic agents for detrusor instability. May be reconsidered after 2-week wash-out.
- If on diuretic, dose has not been stable for at least three months
- Sleep apnea, unless surgically corrected
Data sourced from ClinicalTrials.gov (NCT01187498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.