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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Hospital Universitário Professor Edgard Santos.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
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 August 27, 2014