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

Hospital Universitário Professor Edgard Santos1 site in 1 country42 target enrollmentMay 2012

ConditionsOveractive Bladder Associated With HTLV-1

InterventionsPropantheline Bromide Placebo

DrugsPropantheline Bromide Placebo

Overview

Phase: Phase 1
Intervention: Propantheline Bromide
Conditions: Overactive Bladder Associated With HTLV-1
Sponsor: Hospital Universitário Professor Edgard Santos
Enrollment: 42
Locations: 1
Primary Endpoint: Improve in Overactive bladder symptoms score
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

April 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel