Intermittent Catheterization Versus Trial Without Catheter

NCT ID: NCT05094947

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-03

Study Completion Date

2022-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

intermittent catheterization

Intervention Type PROCEDURE

clean intermittent catheterization with catheter Nelaton

alpha-blockers

Intervention Type DRUG

tamsulosin, alfuzosin, doxazosin, silodosin

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.

Group Type ACTIVE_COMPARATOR

trial without catheter

Intervention Type PROCEDURE

catheter Foley

alpha-blockers

Intervention Type DRUG

tamsulosin, alfuzosin, doxazosin, silodosin

Interventions

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intermittent catheterization

clean intermittent catheterization with catheter Nelaton

Intervention Type PROCEDURE

trial without catheter

catheter Foley

Intervention Type PROCEDURE

alpha-blockers

tamsulosin, alfuzosin, doxazosin, silodosin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

95 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Moscow State University of Medicine and Dentistry

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vigen Malkhasyan

Role: PRINCIPAL_INVESTIGATOR

Moscow state university of medicine and dentistry named after A.I. Evdokimov

Locations

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Moscow state university of medicine and dentistry named after A.I. Evdokimov

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Vigen Malkhasyan

Role: CONTACT

Phone: +7(909) 644-16-88

Email: [email protected]

Sergey Kotov

Role: CONTACT

Phone: +7(965)439-48-39

Email: [email protected]

Facility Contacts

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Vigen Malkhasyan

Role: primary

Other Identifiers

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Moscow MSUMD

Identifier Type: -

Identifier Source: org_study_id