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.
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 3, 2021
CompletedFirst Submitted
Initial submission to the registry
August 10, 2021
CompletedFirst Posted
Study publicly available on registry
October 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedOctober 26, 2021
August 1, 2021
7 months
August 10, 2021
October 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Assessment of the restoration of self-urination.
2 months
Study Arms (2)
intermittent catheterization (group B)
EXPERIMENTALProcedure/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 COMPARATORThe 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
clean intermittent catheterization with catheter Nelaton
tamsulosin, alfuzosin, doxazosin, silodosin
Eligibility Criteria
You may qualify if:
- Men with acute urinary retention due to prostatic hyperplasia
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moscow state university of medicine and dentistry named after A.I. Evdokimov
Moscow, 127473, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vigen Malkhasyan
Moscow state university of medicine and dentistry named after A.I. Evdokimov
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2021
First Posted
October 26, 2021
Study Start
August 3, 2021
Primary Completion
March 1, 2022
Study Completion
May 1, 2022
Last Updated
October 26, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share