Back to resultsIntermittent Catheterization Versus Trial Without Catheter
Primary Purpose
Benign Prostatic Hyperplasia
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
intermittent catheterization
trial without catheter
alpha-blockers
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign prostatic hyperplasia, acute urinary retention, intermittent catheterization, urethral catheter, trial without catheter
Eligibility Criteria
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.
Sites / Locations
- Moscow state university of medicine and dentistry named after A.I. EvdokimovRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
intermittent catheterization (group B)
Catheter Foley (group A)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Assessment of the restoration of self-urination.
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.
Full Information
NCT ID
NCT05094947
First Posted
August 10, 2021
Last Updated
October 15, 2021
Sponsor
Moscow State University of Medicine and Dentistry
1. Study Identification
Unique Protocol Identification Number
NCT05094947
Brief Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 3, 2021 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moscow State University of Medicine and Dentistry
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Benign prostatic hyperplasia, acute urinary retention, intermittent catheterization, urethral catheter, trial without catheter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intermittent catheterization (group B)
Arm Type
Experimental
Arm Description
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.
Arm Title
Catheter Foley (group A)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
intermittent catheterization
Intervention Description
clean intermittent catheterization with catheter Nelaton
Intervention Type
Procedure
Intervention Name(s)
trial without catheter
Intervention Description
catheter Foley
Intervention Type
Drug
Intervention Name(s)
alpha-blockers
Intervention Description
tamsulosin, alfuzosin, doxazosin, silodosin
Primary Outcome Measure Information:
Title
Assessment of the quality of life
Description
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
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Assessment of the restoration of self-urination.
Description
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.
Time Frame
2 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vigen Malkhasyan
Phone
+7(909) 644-16-88
Email
vigenmalkhasyan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sergey Kotov
Phone
+7(965)439-48-39
Email
urokotov@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vigen Malkhasyan
Organizational Affiliation
Moscow state university of medicine and dentistry named after A.I. Evdokimov
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moscow state university of medicine and dentistry named after A.I. Evdokimov
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vigen Malkhasyan
Phone
+7(909) 644-16-88
Email
vigenmalkhasyan@gmail.com
First Name & Middle Initial & Last Name & Degree
Vigen Malkhasyan
First Name & Middle Initial & Last Name & Degree
Dmitriy Pushkar
First Name & Middle Initial & Last Name & Degree
Alexey Volnukhin
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intermittent Catheterization Versus Trial Without Catheter
We'll reach out to this number within 24 hrs