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NCT05094947 Clinical Trial

Intermittent Catheterization Versus Trial Without Catheter

Benign Prostatic Hyperplasia Clinical Trial

Official title:
Indwelling Urinary Catheterization Versus Clean Intermittent Catheterization for the Management of Acute Urinary Retention: Multicenter, Randomized, Controlled Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05094947
Other study ID # Moscow MSUMD
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 3, 2021
Est. completion date May 2022

Study information
Verified date August 2021
Source Moscow State University of Medicine and Dentistry
Contact Vigen Malkhasyan
Phone +7(909) 644-16-88
Email vigenmalkhasyan@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date May 2022
Est. primary completion date March 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 21 Years to 95 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• intermittent catheterization
clean intermittent catheterization with catheter Nelaton
• trial without catheter
catheter Foley
Drug:
• alpha-blockers
tamsulosin, alfuzosin, doxazosin, silodosin

Locations
Country Name City State
Russian Federation Moscow state university of medicine and dentistry named after A.I. Evdokimov Moscow

Sponsors (1)
Lead Sponsor Collaborator
Moscow State University of Medicine and Dentistry

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of the quality of life 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 2 months
Secondary Assessment of the restoration of self-urination. 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. 2 months
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