Indwelling Urinary Catheterization Versus Clean Intermittent Catheterization for the Management of Acute Urinary Retention: Multicenter, Randomized, Controlled Clinical Trial.
Overview
- Phase
- Not Applicable
- Intervention
- intermittent catheterization
- Conditions
- Benign Prostatic Hyperplasia
- Sponsor
- Moscow State University of Medicine and Dentistry
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Assessment of the quality of life
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a prospective, comparative, multicenter, randomized controlled trial. The aim of this study is to compare the efficacy, safety and quality of life within patients with acute urinary retention managed by the intermittent catheterization compared or indwelling Foley catheter.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men with acute urinary retention due to prostatic hyperplasia
Exclusion Criteria
- •Patient's with serious conditions and incapacity
- •Previous urethral or prostate surgery.
- •Urethral stricture.
- •Urethrorrhagia.
- •Injuries of urethra and perineum.
- •Attempts of bladder catheterization within 15 days before the acute urinary retention episode.
- •Urinary tract infection.
- •Neurogenic bladder.
- •Chronic urinary retention with a bladder volume of more than 1 liter.
- •Obstructive uropathy due to the acute urinary retention.
Arms & Interventions
intermittent catheterization (group B)
Procedure/Surgery: The acute urinary retention in group B is managed by clean intermittent catheterization along with alpha-blockers during 3 period. After 3 days the ability of spontaneous voiding is assessed and registered as an outcome.
Intervention: intermittent catheterization
intermittent catheterization (group B)
Procedure/Surgery: The acute urinary retention in group B is managed by clean intermittent catheterization along with alpha-blockers during 3 period. After 3 days the ability of spontaneous voiding is assessed and registered as an outcome.
Intervention: alpha-blockers
Catheter Foley (group A)
The acute urinary retention in group A is managed by trial without catheter along with alpha-blockers during 3 period. After 3 days the indwelling Foley catheter is removed and ability of spontaneous voiding is assessed and registered as an outcome.
Intervention: trial without catheter
Catheter Foley (group A)
The acute urinary retention in group A is managed by trial without catheter along with alpha-blockers during 3 period. After 3 days the indwelling Foley catheter is removed and ability of spontaneous voiding is assessed and registered as an outcome.
Intervention: alpha-blockers
Outcomes
Primary Outcomes
Assessment of the quality of life
Time Frame: 2 months
Assessment of the quality of life according to the SF-36 questionnaire on the first, second, or third day after the start of intermittent catheterization
Secondary Outcomes
- Assessment of the restoration of self-urination.(2 months)