Intermittent Catheterization Versus Trial Without Catheter

Not Applicable

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Procedure: intermittent catheterization; Procedure: trial without catheter; Drug: alpha-blockers

• Registration Number: NCT05094947
• Lead Sponsor: Moscow State University of Medicine and Dentistry

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study Start: 2021-08-03
• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-10-15
• Last Update Submitted: 2021-10-15
• Study First Posted: 2021-10-26
• Last Update Posted: 2021-10-26
• Primary Completion: 2022-03
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intermittent catheterization (group B)	intermittent catheterization	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.
intermittent catheterization (group B)	alpha-blockers	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.
Catheter Foley (group A)	trial without catheter	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.
Catheter Foley (group A)	alpha-blockers	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.

Primary Outcome Measures

Name	Time	Method
Assessment of the quality of life	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 Outcome Measures

Name	Time	Method
Assessment of the restoration of self-urination.	2 months	A positive outcome is considered to be the restoration of independent urination, and the presence of no more than 150 ml of residual urine in a control study 12-24 hours after the restoration of urination.

Trial Locations

Locations (1)

Moscow state university of medicine and dentistry named after A.I. Evdokimov; 🇷🇺 Moscow, Russian Federation