Who is sponsoring COBALT?

COBALT is sponsored by University of Alabama at Birmingham.

What condition does COBALT study?

COBALT studies Overactive Bladder, Lower Urinary Tract Symptoms.

What drugs are being tested in COBALT?

Interventions: Behavioral training, Tolterodine + tamsulosin, Combined Behavioral + Drug Therapy.

Last reviewed 2017-04-17 · How we verify

Combined Behavioral and Drug Treatment of Overactive Bladder in Men (COBALT)

NCT01175382 Phase 2/Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	University of Alabama at Birmingham
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	204
Start date	2010-07
Completion	2015-07

Conditions

Overactive Bladder
Lower Urinary Tract Symptoms

Interventions

Behavioral training
Tolterodine + tamsulosin
Combined Behavioral + Drug Therapy

Primary outcomes

Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward) — From Baseline to 6 Weeks
Bladder diaries completed by subjects prior to randomization and following the first phase of treatment was used to calculate changes in frequency of urination.
Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward) — Change from 6 weeks to 12 weeks
Bladder diaries completed by subjects prior to randomization and following each phase of treatment were used to calculate changes in frequency of urination.
Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward) — Baseline to 12 weeks
Bladder diaries completed by subjects prior to randomization and following the second phase of treatment were used to calculate changes in frequency of urination

Countries

United States