A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder
Recruitment status was Recruiting
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.
Overactive Bladder Associated With HTLV-1
Drug: Propantheline Bromide
|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|
- Improve in Overactive bladder symptoms score [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- Improvement in nocturia and urgency [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
|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)|
|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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|