University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Location status: Recruiting
Recruiting
NCT Number: NCT07379814
Rectus Abdominis Detrusor Myoplasty for Urinary Retention
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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Hypo- or acontractility of the bladder documented on urodynamic testing
- Injury >1 year ago for spinal cord injury patients, no improvement in contractility with time
- Failed sacral nerve stimulation implant for urinary retention treatment (If previously implanted)
- Irreversible non-neurogenic bladder acontractility/hypocontractility (i.e myogenic failure after chronic obstruction, aging, frailty, idiopathic)
- Undergoing RADM
Exclusion criteria
- Documented bladder outlet obstruction
- Spinal cord lesion above T12
- Upper motor neuron lesion (i.e. multiple sclerosis, stroke)
- Rectus diastasis, significant abdominal wall hernia, or other anatomic barrier to rectus flap harvest
- Life expectancy <10 years
- Pregnant at time of surgery
Treatment and study plan
Rectus Abdominal Detrusor Myoplasty
ProcedureIn 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.
Primary outcomes
-
Change in Bladder Compliance
Time frame: 6 Months and 1 Year Post-Op
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 H₂O).
-
Change in Detrusor Pressure
Time frame: 6 Months and 1 Year Post-Op
Detrusor pressure during filling and voiding, including detrusor pressure at maximum flow, will be reported in centimeters of water (cm H₂O).
-
Change in presence of Detrusor Overactivity
Time frame: 6 Months and 1 Year Post-Op
Detrusor overactivity will be recorded as a binary variable (present or absent) based on the occurrence of involuntary detrusor contractions during filling.
-
Change in Urinary Flow Rate
Time frame: 6 Months and 1 Year Post-Op
Maximum urinary flow rate will be reported in milliliters per second (mL/s).
-
Change In Post-Void Residual Urine Volume in Urine
Time frame: 6 Months and 1 Year Post-Op
Post-void residual volume will be measured immediately following voiding and reported in milliliters (mL).
Secondary outcomes
-
Change in quality of life as measured by the Short-Form 36 (SF-36)
Time frame: Month 6 and Year 1 Post-Op
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University Hospitals Cleveland Medical Center
Other
Registry information
Official study title
To Investigate the Outcomes of Rectus Abdominis Flap Detrusor Myoplasty for Urinary Retention
Acronym: RADM
Important dates
- Study start
- 2026
- Primary completion
- 2036
- Study completion
- 2036
- First posted
- Jan 30, 2026
- Registry last updated
- Jul 6, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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