NCT01640002

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Hospital Universitário Professor Edgard Santos · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overactive Bladder Associated With HTLV-1

Interventions

Type	Name	Description
DRUG	Propantheline Bromide	15MG OF PROPANTHELINE BROMIDE, THREE TIMES DAILY FOR 02 MONTHS.
DRUG	Placebo	PLACEBO CAPSULE, 03 TIMES DAILY FOR 02 MONTHS

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-10-01
• Completion: 2013-04-01
• First posted: 2012-07-13
• Last updated: 2012-07-13

Locations

1 site across 1 country: Brazil