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COMPLETED Phase 2

Combined Behavioral and Drug Treatment of Overactive Bladder in Men

NCT01175382 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • BEHAVIORAL Behavioral training
  • DRUG Tolterodine + tamsulosin
  • OTHER Combined Behavioral + Drug Therapy

Study Locations (3)

Alabama

  • University of Alabama at Birmingham — Birmingham

Georgia

  • Emory University — Atlanta

Texas

  • University of Texas Health Science Center San Antonio — San Antonio

Trial Details

FieldValue
Enrollment Target 204 participants
Start Date 2010-07
Est. Completion 2015-07
Phase Phase 2

Sponsor

University of Alabama at Birmingham

1,315 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01175382

The ClinicalTrials.gov registry entry for NCT01175382 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Overactive Bladder appearing as the primary indexed condition, and to 3 interventions — of which Behavioral training is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01175382 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Alabama, Georgia, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01175382 about?

NCT01175382 is a clinical study titled "Combined Behavioral and Drug Treatment of Overactive Bladder in Men". 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 outcom...

What is the current status of trial NCT01175382?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 204 participants. The study started on 2010-07. Estimated completion is 2015-07.

What conditions does trial NCT01175382 study?

This clinical trial studies the following conditions: Overactive Bladder, Lower Urinary Tract Symptoms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01175382?

The interventions under investigation include: Behavioral training (BEHAVIORAL), Tolterodine + tamsulosin (DRUG), Combined Behavioral + Drug Therapy (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01175382?

This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01175382 being conducted?

This trial has 3 study locations across Alabama, Georgia, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial