Phase 3
N=204
Combined Behavioral and Drug Treatment of Overactive Bladder in Men
Overactive Bladder · Lower Urinary Tract Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT01175382 ↗Enrolled (actual)
204
Serious AEs
2.0%
Results posted
May 2017
Primary outcome: Primary: Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward) — 2.7; 1.5; 3.3 voids per day — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Behavioral training (Behavioral); Tolterodine + tamsulosin (Drug); Combined Behavioral + Drug Therapy (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward) |
2.7; 1.5; 3.3 | <.0001 sig |
| PRIMARY Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward) |
0.7; 1.4; 0.2 | .0013 sig |
| PRIMARY Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward) |
3.3; 2.9; 3.5 | 0.2933 |
| SECONDARY Change in Urgency From Baseline to 6 Weeks (Last Observation Carried Forward) |
-0.1; 0.1; 0.2 | 0.0051 sig |
| SECONDARY Change in Urinary Incontinence From Baseline to 6 Weeks (Last Observation Carried Forward) |
3.4; 3.1; 5.2 | .1402 |
| SECONDARY Change in Nocturia From Baseline to 6 Weeks (Last Observation Carried Forward) |
0.7; 0.4; 0.8 | 0.0015 sig |
| SECONDARY Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 6 Weeks (Last Observation Carried Forward) |
19.9; 20.2; 37.5 | <.0001 sig |
| SECONDARY Change in International Prostate Symptom Score (I-PSS) From Baseline to 6 Weeks. (Last Observation Carried Forward) |
4.0; 4.4; 7.9 | <.0001 sig |
| SECONDARY Patient Satisfaction |
13; 9; 24; 39; 33; 31 | 0.0022 sig |
| SECONDARY Patient Perceptions of Improvement |
18; 13; 30; 42; 41; 30 | .0222 sig |
| SECONDARY How Bothersome Were Side Effects? 6 Week Report |
33; 12; 8; 22; 9; 13 | .0217 sig |
| SECONDARY Change in Urgency Score From 6 Weeks to 12 Weeks (Last Observation Carried Forward) |
0.1; 0.1; 0.1 | 0.6690 |
| SECONDARY Change in Urinary Incontinence From 6 Weeks to 12 Weeks (Last Observation Carried Forward) |
1.3; 1.5; 0.0 | 0.0812 |
| SECONDARY Change in Nocturia From 6 Weeks to 12 Weeks (Last Observation Carried Forward) |
0.1; 0.3; 0.1 | 0.5578 |
| SECONDARY Change in Overactive Bladder Questionnaire (OAB-q) From 6 to 12 Weeks (Last Observation Carried Forward) |
17.3; 10.8; 4.6 | 0.0279 sig |
| SECONDARY Change in International Prostate Symptom Score (IPSS) From 6 to 12 Weeks (Last Observation Carried Forward) |
2.7; 2.2; 0.8 | 0.2553 |
| SECONDARY Patient Perception of Improvement at 12 Weeks |
28; 26; 30; 27; 26; 26 | 0.3165 |
| SECONDARY Satisfaction With Progress at 12 Weeks |
32; 32; 28; 26; 28; 29 | 0.8153 |
| SECONDARY How Bothersome Were Side Effects? 12 Week Report |
13; 9; 12; 17; 12; 10 | 0.5536 |
| SECONDARY Change in Nocturia Measured From Baseline to 12 Weeks (Last Observation Carried Forward) |
0.8; 0.7; 0.9 | 0.2035 |
| SECONDARY Change in Urgency Score From Baseline to 12 Weeks (Last Observation Carried Forward) |
0.0; 0.1; 0.2 | .0549 |
| SECONDARY Change in Urinary Incontinence Episodes From Baseline to 12 Weeks (Last Observation Carried Forward) |
4.6; 4.6; 5.2 | 0.5070 |
| SECONDARY Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 12 Weeks (Last Observation Carried Forward) |
37.3; 31.0; 42.1 | .0529 |
| SECONDARY Change in International Prostate Symptom Score (I-PSS) From Baseline to 12 Weeks (Last Observation Carried Forward) |
6.7; 6.7; 8.8 | 0.2384 |
Summary
The primary aim of this project is to evaluate the effectiveness of combined behavioral + drug therapy compared to behavioral treatment alone and drug therapy alone as a way to improve outcomes in the treatment of OAB symptoms in men. We hypothesize that combined therapy will result in better outcomes than either behavioral or drug therapy alone. The second aim is to compare two methods of implementing combined therapy: simultaneously as initial therapy vs. stepped therapy, in which therapies are combined following initial behavioral or drug therapy alone. The third aim is to examine the costs and cost-effectiveness of combined behavioral + drug therapy compared to behavioral or drug therapy alone.
Eligibility Criteria
Inclusion Criteria
- Community-dwelling men
- Age 40 years or older
- Patient-reported urgency and 9.0 or more voids per 24-hour day (on average) on the 7-day baseline bladder diary.
Exclusion Criteria
- Urinary flow rate 9.0 within last 3 months). Subjects with poorly controlled diabetes will be offered enrollment if the OAB symptoms persist after the diabetes is controlled appropriately.
- Hematuria on microscopic examination in the absence of infection. A urologic consultation will be recommended and enrollment will depend on clearance by a urologist and agreement by the Site PI that entry into the treatment protocol is not contraindicated.
- Any unstable medical condition (particularly: cancers under active treatment, decompensated congestive heart failure, history of malignant arrhythmias, unstable angina, diagnosed by history or physical exam).
- Neurologic conditions such as Parkinson's, spinal cord injury, multiple sclerosis, or myasthenia gravis.
- Impaired mental status. Patients who screen as probable dementia on the Mini-Cog.
- Contraindications to the study drugs (tolterodine and tamsulosin) including history of postural hypotension with syncope, history of acute urinary retention requiring catheterization, narrow angle glaucoma, or history of gastric retention.
- Hypersensitivity to tolterodine or tamsulosin.
- Current use of an alpha blocker agent. Evaluation will be delayed until the drug has been discontinued for 2 weeks.
- Current use of an anti-muscarinic agent for OAB. Evaluation will be delayed until the drug has been discontinued for 2 weeks.
- If on a diuretic, dose has not been stable for at least 4 weeks.
- If taking dutasteride or finasteride, dose has not been stable for at least 6 months.
- If on an antibiotic for prostatitis. Patients will be offered re-evaluation if OAB symptoms persist when antibiotics are completed.
- Full course of behavioral training.
Data sourced from ClinicalTrials.gov (NCT01175382). 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.