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

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ClinicalTrials.gov Identifier: NCT01640002
Recruitment Status : Unknown
Verified July 2012 by Jose Abraao Carneiro Neto, Hospital Universitário Professor Edgard Santos.
Recruitment status was:  Recruiting
First Posted : July 13, 2012
Last Update Posted : July 13, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Overactive Bladder Associated With HTLV-1 Drug: Propantheline Bromide Drug: Placebo Phase 1

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder
Study Start Date : May 2012
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : April 2013


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Improve in Overactive bladder symptoms score [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Improvement in nocturia and urgency [ Time Frame: 2 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012

Keywords provided by Jose Abraao Carneiro Neto, Hospital Universitário Professor Edgard Santos:
overactive bladder
HTLV-1
Propantheline
anticholinergic

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