Phase 3
Completed N=143
Behavioral Treatment of Overactive Bladder in Men
Source: ClinicalTrials.gov NCT01187498 ↗Enrolled (actual)
143
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: 24-hour Voiding Frequency — 9.1; 9.5 voids per 24-hour day — p=.001
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.
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 |
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. Informational only — not medical advice.