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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intermittent catheterization | Procedure | clean intermittent catheterization with catheter Nelaton |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months |
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Inclusion Criteria:
Men with acute urinary retention due to prostatic hyperplasia
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vigen Malkhasyan | Contact | +7(909) 644-16-88 | vigenmalkhasyan@gmail.com | |
| Sergey Kotov | Contact | +7(965)439-48-39 | urokotov@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Vigen Malkhasyan | Moscow state university of medicine and dentistry named after A.I. Evdokimov | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow state university of medicine and dentistry named after A.I. Evdokimov | Recruiting | Moscow | 127473 | Russia |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 20, 2022 | |
| Reset | Aug 31, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 20, 2022 | Aug 31, 2023 |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D057928 | Intermittent Urethral Catheterization |
| D002986 | Clinical Trials as Topic |
| D057785 | Catheters |
| D000317 | Adrenergic alpha-Antagonists |
| ID | Term |
|---|---|
| D014546 | Urinary Catheterization |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| trial without catheter | Procedure | catheter Foley |
|
| alpha-blockers | Drug | tamsulosin, alfuzosin, doxazosin, silodosin |
|
| D052801 |
| Male Urogenital Diseases |
| D000068456 |
| Clinical Studies as Topic |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D004864 | Equipment and Supplies |
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |