Trial record 10 of 261 for: Open Studies | "Urinary Bladder Diseases"

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A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder

This study is currently recruiting participants.

Verified July 2012 by Hospital Universitário Professor Edgard Santos

Sponsor:

Information provided by (Responsible Party):

Jose Abraao Carneiro Neto, Hospital Universitário Professor Edgard Santos

ClinicalTrials.gov Identifier:

NCT01640002

First received: July 11, 2012

Last updated: July 12, 2012

Last verified: July 2012

History of Changes

Purpose

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	Intervention	Phase
Overactive Bladder Associated With HTLV-1	Drug: Propantheline Bromide Drug: Placebo	Phase 1

Study Type:	Interventional
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

Resource links provided by NLM:

Drug Information available for: Propantheline bromide

U.S. FDA Resources

Further study details as provided by Hospital Universitário Professor Edgard Santos:

Primary Outcome Measures:

Improve in Overactive bladder symptoms score [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Improvement in nocturia and urgency [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	42
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)

Arms	Assigned Interventions
Active Comparator: Propantheline	Drug: Propantheline Bromide 15MG OF PROPANTHELINE BROMIDE, THREE TIMES DAILY FOR 02 MONTHS.
Placebo Comparator: Placebo	Drug: Placebo PLACEBO CAPSULE, 03 TIMES DAILY FOR 02 MONTHS

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01640002

Contacts

Contact: Jose Abraão Carneiro Neto

55+71+8149-1252

abraao.neto@gmail.com

Locations

Brazil
Service of Imunology - Universitary Hospital Prof. Edgard Santos	Recruiting
Salvador, Bahia, Brazil, 40110-070
Contact: José Abraão Carneiro Neto 557132838392 abraao.neto@gmail.com
Contact: Edgard Marcelino Carvalho Filho imuno@ufba.br
Principal Investigator: Edgard Marcelino Carvalho Filho

Sponsors and Collaborators

Hospital Universitário Professor Edgard Santos

Investigators

Principal Investigator:

José Abraão Carneiro Neto

Service of Imunology - Universitary Hospital Prof. Edgard Santos

More Information

Publications:

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.

Oliveira P, Castro NM, Muniz AL, Tanajura D, Brandão 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. Epub 2010 Feb 26.

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.

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. Epub 2011 Mar 8.

Caskey MF, Morgan DJ, Porto AF, Giozza SP, Muniz AL, Orge GO, Travassos MJ, Barrón 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.

Gomes I, Melo A, Proietti FA, Moreno-Carvalho O, Loures LA, Dazza MC, Said G, Larouzé B, Galvão-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.

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.

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 Report Med. 2011;2011:289389. Epub 2011 Apr 13.

Thüroff JW, Bunke B, Ebner A, Faber P, de Geeter P, Hannappel J, Heidler H, Madersbacher H, Melchior H, Schäfer 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.

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.

Responsible Party:	Jose Abraao Carneiro Neto, MD, Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier:	NCT01640002 History of Changes
Other Study ID Numbers:	FR-473218
Study First Received:	July 11, 2012
Last Updated:	July 12, 2012
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Universitário Professor Edgard Santos:

overactive bladder
HTLV-1
Propantheline
anticholinergic

Additional relevant MeSH terms:

Urinary Bladder Diseases
Urinary Bladder, Overactive
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Bromides
Propantheline
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013

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