Intermittent Catheterization Versus Trial Without Catheter

Moscow State University of Medicine and Dentistry

Status: Unknown

Conditions: Benign Prostatic Hyperplasia

Treatments: Procedure: trial without catheter; Drug: alpha-blockers; Procedure: intermittent catheterization

Study type: Interventional

Funder types: Other

Identifiers

NCT05094947

Moscow MSUMD

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 21 to 95 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

intermittent catheterization (group B)

Experimental group

Description:

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.

Treatment:

Drug: alpha-blockers

Procedure: intermittent catheterization

Catheter Foley (group A)

Active Comparator group

Description:

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.

Treatment:

Drug: alpha-blockers

Procedure: trial without catheter