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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01640002
Enrollment
42
Registered
2012-07-13
Start date
2012-05-31
Completion date
2013-04-30
Last updated
2012-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder Associated With HTLV-1

Keywords

overactive bladder, HTLV-1, Propantheline, anticholinergic

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.

Interventions

DRUGPropantheline Bromide

15MG OF PROPANTHELINE BROMIDE, THREE TIMES DAILY FOR 02 MONTHS.

DRUGPlacebo

PLACEBO CAPSULE, 03 TIMES DAILY FOR 02 MONTHS

Sponsors

Hospital Universitário Professor Edgard Santos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Improve in Overactive bladder symptoms score2 months

Secondary

MeasureTime frame
Improvement in nocturia and urgency2 months

Countries

Brazil

Contacts

Primary ContactJose Abraão Carneiro Neto
abraao.neto@gmail.com55+71+8149-1252

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026