A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder

Phase 1

• Conditions: Overactive Bladder Associated With HTLV-1
• Interventions: Drug: Propantheline Bromide; Drug: Placebo

• Registration Number: NCT01640002
• Lead Sponsor: Hospital Universitário Professor Edgard Santos

Brief Summary

It's a double blind, placebo controlled study to assess the efficacy of Propantheline Bromide to treat overactive bladder (OAB) in HTLV 1 infected patients.

We think that the treatment of the OAB with Propantheline could reduce nocturia and frequency in sixty percent.

Detailed Description

Double blind, placebo controlled study to assess the efficacy of Propantheline Bromide to treat overactive bladder (OAB) in HTLV 1 infected patients

Treatment Group Propantheline Bromide: 15mg, three times daily for 08 weeks.

Control Group Placebo 03 times daily

Case definition Clinically defined OAB patients (ICS criteria), infected by HTLV-1. Frequency was defined as more than 08 daytime voids. Nocturia was defined as more than 02 voids after sleeping.

Inclusion criteria More than 18 year. HTLV-1 infected patients with overactive bladder. Negative culture of urine. Without neurological impairment.

Exclusion criteria Persistently positive urine culture

History of:

Allergy to medication, head or spinal trauma. Head and neck, neurological,spinal, lower abdominal or pelvic surgery. Stroke. Users of urinary catheters.

Study Timeline

• Study Start: 2012-05
• Status Verified: 2012-07
• Study First Submitted: 2012-07-11
• Study First Submitted QC: 2012-07-12
• Last Update Submitted: 2012-07-12
• Study First Posted: 2012-07-13
• Last Update Posted: 2012-07-13
• Primary Completion: 2012-10
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• HTLV-1 infection
• More than 18 years
• Negative urine culture
• No neurological damage

Exclusion Criteria

• Diabetes
• Persistently positive urine culture
• Pelvic, head, urological or gynecological surgery
• Stroke

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propantheline	Propantheline Bromide	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Improve in Overactive bladder symptoms score	2 months

Secondary Outcome Measures

Name	Time	Method
Improvement in nocturia and urgency	2 months

Trial Locations

Locations (1)

Service of Imunology - Universitary Hospital Prof. Edgard Santos; 🇧🇷 Salvador, Bahia, Brazil