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This investigates the outcomes of a surgical technique using the patient's own abdominal wall muscles to help contract the bladder in patients with urinary retention
This study is about a surgery called Rectus Abdominis Detrusor Myoplasty (RADM). In this surgery, a small piece of the belly muscle is moved and wrapped around your bladder to help it squeeze and empty urine. Doctors are studying this surgery because current treatments, like catheters or nerve implants, don't always work for people whose bladders don't contract on their own. This study monitors the patients' progress for a year following this surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individiuals receiving Rectus Abdominis Detrusor Myoplasty (RADM) | Individuals diagnosed with refractory urinary retention that have failed conventional approaches to treat urinary retention such as catheterization and neurostimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectus Abdominal Detrusor Myoplasty | Procedure | In this surgery, the rectus abdominis muscle will be elevated and wrapped circumferentially around the bladder to augment bladder contraction in individuals with bladder acontractility or hypocontractility. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bladder Compliance | Bladder compliance will be calculated as the change in bladder volume divided by the change in detrusor pressure during the filling phase and reported in milliliters per centimeter of water (mL/cm Hâ‚‚O). | 6 Months and 1 Year Post-Op |
| Change in Detrusor Pressure | Detrusor pressure during filling and voiding, including detrusor pressure at maximum flow, will be reported in centimeters of water (cm Hâ‚‚O). | 6 Months and 1 Year Post-Op |
| Change in presence of Detrusor Overactivity | Detrusor overactivity will be recorded as a binary variable (present or absent) based on the occurrence of involuntary detrusor contractions during filling. | 6 Months and 1 Year Post-Op |
| Change in Urinary Flow Rate | Maximum urinary flow rate will be reported in milliliters per second (mL/s). | 6 Months and 1 Year Post-Op |
| Change In Post-Void Residual Urine Volume in Urine | Post-void residual volume will be measured immediately following voiding and reported in milliliters (mL). | 6 Months and 1 Year Post-Op |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life as measured by the Short-Form 36 (SF-36) | This is a validated questionnaire measuring health-related quality of life through eight domains, covering physical and mental well-being. It's widely used in healthcare to assess overall health perception and functional status. With higher scores indicating greater quality of life. | Month 6 and Year 1 Post-Op |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals diagnosed with refractory urinary retention undergoing RADM
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seyed Sajjad Tabei | Contact | 216-844-8963 | seyedsajjad.tabei@uhhospitals.org |
| Name | Affiliation | Role |
|---|---|---|
| Shubham Gupta, MD | University Hospitals Cleveland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |