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

This study is currently recruiting participants.
Verified July 2012 by Hospital Universitário Professor Edgard Santos
Sponsor:
Information provided by (Responsible Party):
Jose Abraao Carneiro Neto, Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier:
NCT01640002
First received: July 11, 2012
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Overactive Bladder Associated With HTLV-1
Drug: Propantheline Bromide
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder

Resource links provided by NLM:


Further study details as provided by Hospital Universitário Professor Edgard Santos:

Primary Outcome Measures:
  • Improve in Overactive bladder symptoms score [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in nocturia and urgency [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: May 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propantheline Drug: Propantheline Bromide
15MG OF PROPANTHELINE BROMIDE, THREE TIMES DAILY FOR 02 MONTHS.
Placebo Comparator: Placebo Drug: Placebo
PLACEBO CAPSULE, 03 TIMES DAILY FOR 02 MONTHS

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01640002

Contacts
Contact: Jose Abraão Carneiro Neto 55+71+8149-1252 abraao.neto@gmail.com

Locations
Brazil
Service of Imunology - Universitary Hospital Prof. Edgard Santos Recruiting
Salvador, Bahia, Brazil, 40110-070
Contact: José Abraão Carneiro Neto    557132838392    abraao.neto@gmail.com   
Contact: Edgard Marcelino Carvalho Filho       imuno@ufba.br   
Principal Investigator: Edgard Marcelino Carvalho Filho         
Sponsors and Collaborators
Hospital Universitário Professor Edgard Santos
Investigators
Principal Investigator: José Abraão Carneiro Neto Service of Imunology - Universitary Hospital Prof. Edgard Santos
  More Information

Publications:

Responsible Party: Jose Abraao Carneiro Neto, MD, Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier: NCT01640002     History of Changes
Other Study ID Numbers: FR-473218
Study First Received: July 11, 2012
Last Updated: July 12, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Universitário Professor Edgard Santos:
overactive bladder
HTLV-1
Propantheline
anticholinergic

Additional relevant MeSH terms:
Urinary Bladder Diseases
Urinary Bladder, Overactive
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Bromides
Propantheline
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014