Rectus Abdominis Detrusor Myoplasty for Urinary Retention (RADM)

To Investigate the Outcomes of Rectus Abdominis Flap 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

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Retention; Urinary Retention Postoperative; Urinary Retention After Procedure
• Intervention / Treatment: Procedure: Rectus Abdominal Detrusor Myoplasty

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Seyed Sajjad Tabei; Phone Number: 216-844-8963; Email: seyedsajjad.tabei@uhhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals diagnosed with refractory urinary retention undergoing RADM

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Rectus Abdominal Detrusor Myoplasty; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 H₂O).	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 H₂O).	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: Shubham Gupta, MD, University Hospitals Cleveland

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2036
• Study Completion (Estimated): May 1, 2036

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: urinary retention
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urinary Retention
• Other Study ID Numbers: STUDY20251303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No