A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder
Primary Purpose
Overactive Bladder Associated With HTLV-1
Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Propantheline Bromide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder Associated With HTLV-1 focused on measuring overactive bladder, HTLV-1, Propantheline, anticholinergic
Eligibility 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
Sites / Locations
- Service of Imunology - Universitary Hospital Prof. Edgard SantosRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Propantheline
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Improve in Overactive bladder symptoms score
Secondary Outcome Measures
Improvement in nocturia and urgency
Full Information
NCT ID
NCT01640002
First Posted
July 11, 2012
Last Updated
July 12, 2012
Sponsor
Hospital Universitário Professor Edgard Santos
1. Study Identification
Unique Protocol Identification Number
NCT01640002
Brief Title
A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder
Official Title
A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
April 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitário Professor Edgard Santos
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Associated With HTLV-1
Keywords
overactive bladder, HTLV-1, Propantheline, anticholinergic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Propantheline
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Propantheline Bromide
Intervention Description
15MG OF PROPANTHELINE BROMIDE, THREE TIMES DAILY FOR 02 MONTHS.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
PLACEBO CAPSULE, 03 TIMES DAILY FOR 02 MONTHS
Primary Outcome Measure Information:
Title
Improve in Overactive bladder symptoms score
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Improvement in nocturia and urgency
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Abraão Carneiro Neto
Phone
55+71+8149-1252
Email
abraao.neto@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Abraão Carneiro Neto
Organizational Affiliation
Service of Imunology - Universitary Hospital Prof. Edgard Santos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service of Imunology - Universitary Hospital Prof. Edgard Santos
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40110-070
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Abraão Carneiro Neto
Phone
557132838392
Email
abraao.neto@gmail.com
First Name & Middle Initial & Last Name & Degree
Edgard Marcelino Carvalho Filho
Email
imuno@ufba.br
First Name & Middle Initial & Last Name & Degree
Edgard Marcelino Carvalho Filho
12. IPD Sharing Statement
Citations:
PubMed Identifier
17352816
Citation
Rocha PN, Rehem AP, Santana JF, Castro N, Muniz AL, Salgado K, Rocha H, Carvalho EM. The cause of urinary symptoms among Human T Lymphotropic Virus Type I (HLTV-I) infected patients: a cross sectional study. BMC Infect Dis. 2007 Mar 12;7:15. doi: 10.1186/1471-2334-7-15.
Results Reference
background
PubMed Identifier
21388871
Citation
Poetker SK, Porto AF, Giozza SP, Muniz AL, Caskey MF, Carvalho EM, Glesby MJ. Clinical manifestations in individuals with recent diagnosis of HTLV type I infection. J Clin Virol. 2011 May;51(1):54-8. doi: 10.1016/j.jcv.2011.02.004. Epub 2011 Mar 8.
Results Reference
background
PubMed Identifier
17411369
Citation
Caskey MF, Morgan DJ, Porto AF, Giozza SP, Muniz AL, Orge GO, Travassos MJ, Barron Y, Carvalho EM, Glesby MJ. Clinical manifestations associated with HTLV type I infection: a cross-sectional study. AIDS Res Hum Retroviruses. 2007 Mar;23(3):365-71. doi: 10.1089/aid.2006.0140.
Results Reference
background
PubMed Identifier
10426153
Citation
Gomes I, Melo A, Proietti FA, Moreno-Carvalho O, Loures LA, Dazza MC, Said G, Larouze B, Galvao-Castro B. Human T lymphotropic virus type I (HTLV-I) infection in neurological patients in Salvador, Bahia, Brazil. J Neurol Sci. 1999 May 1;165(1):84-9. doi: 10.1016/s0022-510x(99)00083-0.
Results Reference
background
PubMed Identifier
20038241
Citation
Garlet GP, Giozza SP, Silveira EM, Claudino M, Santos SB, Avila-Campos MJ, Martins W Jr, Cardoso CR, Trombone AP, Campanelli AP, Carvalho EM, Silva JS. Association of human T lymphotropic virus 1 amplification of periodontitis severity with altered cytokine expression in response to a standard periodontopathogen infection. Clin Infect Dis. 2010 Feb 1;50(3):e11-8. doi: 10.1086/649871.
Results Reference
background
PubMed Identifier
21541226
Citation
Tannus M, Tanajura D, Sundberg MA, Oliveira P, Castro N, Santos AM. Detrusor Arreflexia as an End Stage of Neurogenic Bladder in HAM/TSP? Case Rep Med. 2011;2011:289389. doi: 10.1155/2011/289389. Epub 2011 Apr 13.
Results Reference
background
PubMed Identifier
2005707
Citation
Thuroff JW, Bunke B, Ebner A, Faber P, de Geeter P, Hannappel J, Heidler H, Madersbacher H, Melchior H, Schafer W, et al. Randomized, double-blind, multicenter trial on treatment of frequency, urgency and incontinence related to detrusor hyperactivity: oxybutynin versus propantheline versus placebo. J Urol. 1991 Apr;145(4):813-6; discussion 816-7. doi: 10.1016/s0022-5347(17)38459-8.
Results Reference
background
PubMed Identifier
21855969
Citation
Gotoh M, Homma Y, Yokoyama O, Nishizawa O. Responsiveness and minimal clinically important change in overactive bladder symptom score. Urology. 2011 Oct;78(4):768-73. doi: 10.1016/j.urology.2011.06.020.
Results Reference
background
PubMed Identifier
17482910
Citation
Castro NM, Rodrigues W Jr, Freitas DM, Muniz A, Oliveira P, Carvalho EM. Urinary symptoms associated with human T-cell lymphotropic virus type I infection: evidence of urinary manifestations in large group of HTLV-I carriers. Urology. 2007 May;69(5):813-8. doi: 10.1016/j.urology.2007.01.052.
Results Reference
result
PubMed Identifier
20189229
Citation
Oliveira P, Castro NM, Muniz AL, Tanajura D, Brandao JC, Porto AF, Carvalho EM. Prevalence of erectile dysfunction in HTLV-1-infected patients and its association with overactive bladder. Urology. 2010 May;75(5):1100-3. doi: 10.1016/j.urology.2009.11.041. Epub 2010 Feb 26.
Results Reference
result
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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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