Intermittent Catheterization Versus Trial Without Catheter

October 15, 2021 updated by: Moscow State University of Medicine and Dentistry

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 127473
        • Recruiting
        • Moscow state university of medicine and dentistry named after A.I. Evdokimov
        • Sub-Investigator:
          • Dmitriy Pushkar
        • Principal Investigator:
          • Vigen Malkhasyan
        • Sub-Investigator:
          • Alexey Volnukhin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: intermittent catheterization
clean intermittent catheterization with catheter Nelaton
Drug: alpha-blockers
tamsulosin, alfuzosin, doxazosin, silodosin
Active Comparator: 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.
Drug: alpha-blockers
tamsulosin, alfuzosin, doxazosin, silodosin
Procedure: trial without catheter
catheter Foley

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the restoration of self-urination.
Time Frame: 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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moscow State University of Medicine and Dentistry

Investigators

  • Principal Investigator: Vigen Malkhasyan, Moscow state university of medicine and dentistry named after A.I. Evdokimov

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (Actual)

October 26, 2021

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 15, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Moscow MSUMD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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