Benign Prostatic HyperplasiaNCT05094947
Intermittent Catheterization Versus Trial Without Catheter
A study testing intermittent catheterization, trial without catheter and alpha-blockers in people with Benign Prostatic Hyperplasia, run by Moscow State University of Medicine and Dentistry at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 95 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- intermittent catheterization, trial without catheter and alpha-blockers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 3 Aug 2021to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 95 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men with acute urinary retention due to prostatic hyperplasia
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Moscow state university of medicine and dentistry named after A.I. Evdokimov
Moscow, 127473
Vigen Malkhasyan, +7(909) 644-16-88, vigenmalkhasyan@gmail.com
Vigen Malkhasyan
About this study
Official title: Indwelling Urinary Catheterization Versus Clean Intermittent Catheterization for the Management of Acute Urinary Retention: Multicenter, Randomized, Controlled Clinical Trial.
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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- intermittent catheterization, trial without catheter, alpha-blockers
- Keywords
- Benign prostatic hyperplasia, acute urinary retention, intermittent catheterization, urethral catheter, trial without catheter
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent catheterizationProcedure or surgery
clean intermittent catheterization with catheter Nelaton
trial without catheterProcedure or surgery
catheter Foley
alpha-blockersDrug
tamsulosin, alfuzosin, doxazosin, silodosin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: intermittent catheterization; Drug: alpha-blockers |
| 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. Receives: Procedure: trial without catheter; Drug: alpha-blockers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
Secondary outcomes (1)
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start3 Aug 2021
- Primary completionMar 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moscow State University of Medicine and Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vigen Malkhasyan, Principal investigator, Moscow state university of medicine and dentistry named after A.I. Evdokimov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094947
- Sponsor's protocol ID
- Moscow MSUMD
- Status last verified
- Aug 2021
- First submitted
- 10 Aug 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indwelling Urinary Catheterization Versus Clean Intermittent Catheterization for the Management of Acute Urinary Retention: Multicenter, Randomized, Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05094947
- Acronym / sponsor ID
- Moscow MSUMD
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Benign prostatic hyperplasia, acute urinary retention, intermittent catheterization, urethral catheter, trial without catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Moscow State University of Medicine and DentistryUniversity, hospital or other
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intermittent catheterization (group B) | Experimental | Procedure: intermittent catheterization, Drug: alpha-blockersProcedure/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 | Procedure: trial without catheter, Drug: alpha-blockersThe 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. |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men with acute urinary retention due to prostatic hyperplasia
Key exclusion criteria (10 listed)
- Patient's with serious conditions and incapacity
- Previous urethral or prostate surgery.
- Urethral stricture.
- Urethrorrhagia.
- Injuries of urethra and perineum.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intermittent catheterizationclean intermittent catheterization with catheter Nelaton | Procedure or surgery | intermittent catheterization (group B) |
| trial without cathetercatheter Foley | Procedure or surgery | Catheter Foley (group A) |
| alpha-blockerstamsulosin, alfuzosin, doxazosin, silodosin | Drug | Catheter Foley (group A), intermittent catheterization (group B) |
Primary outcome
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
1 secondary outcome
Assessment of the restoration of self-urination.
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vigen Malkhasyan principal investigator
Moscow state university of medicine and dentistry named after A.I. Evdokimov
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent catheterization, trial without catheter and alpha-blockers in people with Benign Prostatic Hyperplasia, run by Moscow State University of Medicine and Dentistry at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vigen Malkhasyan (+7(909) 644-16-88, vigenmalkhasyan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the quality of life (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.