Intermittent Catheterization Versus Trial Without Catheter

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05094947

Enrollment

200

Registered

2021-10-26

Start date

2021-08-03

Completion date

2022-05-31

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign prostatic hyperplasia, acute urinary retention, intermittent catheterization, urethral catheter, trial without catheter

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.

Interventions

PROCEDUREintermittent catheterization

clean intermittent catheterization with catheter Nelaton

PROCEDUREtrial without catheter

catheter Foley

DRUGalpha-blockers

tamsulosin, alfuzosin, doxazosin, silodosin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

21 Years to 95 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Russia

Contacts

Primary ContactVigen Malkhasyan

vigenmalkhasyan@gmail.com+7(909) 644-16-88

Backup ContactSergey Kotov

urokotov@mail.ru+7(965)439-48-39

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026