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

Overactive Bladder Associated With HTLV-1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01640002
• Other study ID #: FR-473218
• Status: Recruiting
• Phase: Phase 1
• First received: July 11, 2012
• Last updated: July 12, 2012
• Start date: May 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2012
• Source: Hospital Universitário Professor Edgard Santos
• Contact: Jose Abraão Carneiro Neto
• Phone: 55+71+8149-1252
• Email: abraao.neto[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: April 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder Associated With HTLV-1
• Urinary Bladder, Overactive

Intervention

Drug:
• Propantheline Bromide
15MG OF PROPANTHELINE BROMIDE, THREE TIMES DAILY FOR 02 MONTHS.
• Placebo
PLACEBO CAPSULE, 03 TIMES DAILY FOR 02 MONTHS

Locations

Country	Name	City	State
Brazil	Service of Imunology - Universitary Hospital Prof. Edgard Santos	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitário Professor Edgard Santos

Country where clinical trial is conducted

Brazil, 

References & Publications (10)

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. — View 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 — View 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. — View Citation

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. — View 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. — View Citation

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. doi: 10.1016/j.urology.2009.11.041. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improve in Overactive bladder symptoms score		2 months	Yes
Secondary	Improvement in nocturia and urgency		2 months	Yes