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

Hospital Universitário Professor Edgard Santos

Status and phase: Unknown; Phase 1

Conditions: Overactive Bladder Associated With HTLV-1

Treatments: Drug: Placebo; Drug: Propantheline Bromide

Study type: Interventional

Funder types: Other

Identifiers

NCT01640002

FR-473218

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

Propantheline

Active Comparator group

Treatment:

Drug: Propantheline Bromide

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo