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

H

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

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

Trial contacts and locations

1

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Central trial contact

Jose Abraão Carneiro Neto

Data sourced from clinicaltrials.gov

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