A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder
NCT ID: NCT01640002
Last Updated: 2012-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
42 participants
INTERVENTIONAL
2012-05-31
2013-04-30
Brief Summary
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We think that the treatment of the OAB with Propantheline could reduce nocturia and frequency in sixty percent.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Propantheline
Propantheline Bromide
15MG OF PROPANTHELINE BROMIDE, THREE TIMES DAILY FOR 02 MONTHS.
Placebo
Placebo
PLACEBO CAPSULE, 03 TIMES DAILY FOR 02 MONTHS
Interventions
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Propantheline Bromide
15MG OF PROPANTHELINE BROMIDE, THREE TIMES DAILY FOR 02 MONTHS.
Placebo
PLACEBO CAPSULE, 03 TIMES DAILY FOR 02 MONTHS
Eligibility Criteria
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Inclusion Criteria
* More than 18 years
* Negative urine culture
* No neurological damage
Exclusion Criteria
* Persistently positive urine culture
* Pelvic, head, urological or gynecological surgery
* Stroke
18 Years
ALL
No
Sponsors
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Hospital Universitário Professor Edgard Santos
OTHER
Responsible Party
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Jose Abraao Carneiro Neto
MD
Principal Investigators
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José Abraão Carneiro Neto
Role: PRINCIPAL_INVESTIGATOR
Service of Imunology - Universitary Hospital Prof. Edgard Santos
Locations
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Service of Imunology - Universitary Hospital Prof. Edgard Santos
Salvador, Estado de Bahia, Brazil
Countries
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Central Contacts
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Facility Contacts
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José Abraão Carneiro Neto
Role: primary
Edgard Marcelino Carvalho Filho
Role: backup
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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FR-473218
Identifier Type: -
Identifier Source: org_study_id