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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):
Jose Abraao Carneiro Neto, Hospital Universitário Professor Edgard Santos

Tracking Information
First Submitted Date  ICMJE July 11, 2012
First Posted Date  ICMJE July 13, 2012
Last Update Posted Date July 13, 2012
Study Start Date  ICMJE May 2012
Estimated Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2012)
Improve in Overactive bladder symptoms score [ Time Frame: 2 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2012)
Improvement in nocturia and urgency [ Time Frame: 2 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder
Official Title  ICMJE A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder
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.

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 Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder Associated With HTLV-1
Intervention  ICMJE
  • Drug: Propantheline Bromide
    15MG OF PROPANTHELINE BROMIDE, THREE TIMES DAILY FOR 02 MONTHS.
  • Drug: Placebo
    PLACEBO CAPSULE, 03 TIMES DAILY FOR 02 MONTHS
Study Arms
  • Active Comparator: Propantheline
    Intervention: Drug: Propantheline Bromide
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 12, 2012)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date April 2013
Estimated Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01640002
Other Study ID Numbers  ICMJE FR-473218
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jose Abraao Carneiro Neto, Hospital Universitário Professor Edgard Santos
Study Sponsor  ICMJE Hospital Universitário Professor Edgard Santos
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: José Abraão Carneiro Neto Service of Imunology - Universitary Hospital Prof. Edgard Santos
PRS Account Hospital Universitário Professor Edgard Santos
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP