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
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|
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
Allergy to medication, head or spinal trauma. Head and neck, neurological,spinal, lower abdominal or pelvic surgery. Stroke. Users of urinary catheters.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Active Comparator: Propantheline||
Drug: Propantheline Bromide
15MG OF PROPANTHELINE BROMIDE, THREE TIMES DAILY FOR 02 MONTHS.
|Placebo Comparator: Placebo||
PLACEBO CAPSULE, 03 TIMES DAILY FOR 02 MONTHS
- Improve in Overactive bladder symptoms score [ Time Frame: 2 months ]
- Improvement in nocturia and urgency [ Time Frame: 2 months ]
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
|Contact: Jose Abraão Carneiro Netofirstname.lastname@example.org|
|Service of Imunology - Universitary Hospital Prof. Edgard Santos||Recruiting|
|Salvador, Bahia, Brazil, 40110-070|
|Contact: José Abraão Carneiro Neto 557132838392 email@example.com|
|Contact: Edgard Marcelino Carvalho Filho firstname.lastname@example.org|
|Principal Investigator: Edgard Marcelino Carvalho Filho|
|Principal Investigator:||José Abraão Carneiro Neto||Service of Imunology - Universitary Hospital Prof. Edgard Santos|