---
title: Intermittent Catheterization Versus Trial Without Catheter
nct_id: NCT05094947
overall_status: UNKNOWN
phase: NA
sponsor: Moscow State University of Medicine and Dentistry
study_type: INTERVENTIONAL
primary_condition: Benign Prostatic Hyperplasia
countries: Russia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05094947.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05094947"
ct_last_update_post_date: 2021-10-26
last_seen_at: "2026-05-12T06:43:10.384Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Intermittent Catheterization Versus Trial Without Catheter

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

**NCT ID:** [NCT05094947](https://clinicaltrials.gov/study/NCT05094947)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** Moscow State University of Medicine and Dentistry
- **Conditions:** Benign Prostatic Hyperplasia
- **Start Date:** 2021-08-03
- **Completion Date:** 2022-05
- **CT.gov Last Update:** 2021-10-26

## 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.

## Eligibility

- **Minimum age:** 21 Years
- **Maximum age:** 95 Years
- **Sex:** MALE
- **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.
```

## Arms

- **intermittent catheterization (group B)** (EXPERIMENTAL) — 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)** (ACTIVE_COMPARATOR) — 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.

## Interventions

- **intermittent catheterization** (PROCEDURE) — clean intermittent catheterization with catheter Nelaton
- **trial without catheter** (PROCEDURE) — catheter Foley
- **alpha-blockers** (DRUG) — tamsulosin, alfuzosin, doxazosin, silodosin

## Primary Outcomes

- **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

## Secondary Outcomes

- **Assessment of the restoration of self-urination.** _(time frame: 2 months)_

## Locations (1)

- Moscow state university of medicine and dentistry named after A.I. Evdokimov, Moscow, Russia — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.moscow state university of medicine and dentistry named after a.i. evdokimov|moscow||russia` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05094947.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05094947*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*
