Urinary RetentionRADMNCT07379814
Rectus Abdominis Detrusor Myoplasty for Urinary Retention
An observational study of Urinary Retention and Urinary Retention After Procedure, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urinary Retention, Urinary Retention After Procedure, Urinary Retention Postoperative
- What is being tested?
- Rectus Abdominal Detrusor Myoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 1 May 2036
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals diagnosed with refractory urinary retention undergoing RADM
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Seyed Tabei, 216-844-8963, seyedsajjad.tabei@uhhospitals.org
About this study
Official title: 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
Read the 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.
- Being tested
- Rectus Abdominal Detrusor Myoplasty
- Keywords
- urinary retention
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectus Abdominal Detrusor MyoplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Rectus Abdominal Detrusor Myoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 6 Months and 1 Year Post-Op
Secondary outcomes (1)
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.
Measured: Month 6 and Year 1 Post-Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 May 2026
- Primary completion1 May 2036 (estimated)
- Study completion1 May 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shubham Gupta, University Hospitals Cleveland Medical Center
- Investigators
- Shubham Gupta, MD, Principal investigator, University Hospitals Cleveland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379814
- Sponsor's protocol ID
- STUDY20251303
- Acronym
- RADM
- Status last verified
- Jul 2026
- First submitted
- 23 Jan 2026
- Last updated
- 6 Jul 2026
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Outcomes of Rectus Abdominis Flap Detrusor Myoplasty for Urinary Retention
- ClinicalTrials.gov ID
- NCT07379814
- Acronym / sponsor ID
- RADM / STUDY20251303
- Keywords
- urinary retention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2036 (estimated)
- Study completion
- 1 May 2036 (estimated)
- First posted
- 30 Jan 2026 (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 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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individiuals receiving Rectus Abdominis Detrusor Myoplasty (RADM) | – | Procedure: Rectus Abdominal Detrusor MyoplastyIndividuals diagnosed with refractory urinary retention that have failed conventional approaches to treat urinary retention such as catheterization and neurostimulation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals diagnosed with refractory urinary retention undergoing RADM
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Rectus Abdominal Detrusor MyoplastyIn 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. | Procedure or surgery | Individiuals receiving Rectus Abdominis Detrusor Myoplasty (RADM) |
Primary outcome
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).
1 secondary outcome
Change in quality of life as measured by the Short-Form 36 (SF-36)
Time frame: Month 6 and Year 1 Post-Op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- 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.
Shubham Gupta, MD principal investigator
University Hospitals Cleveland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Retention and Urinary Retention After Procedure, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seyed Sajjad Tabei (216-844-8963, seyedsajjad.tabei@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bladder Compliance (time frame: 6 Months and 1 Year Post-Op). The study lists 5 primary outcomes in all. 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 6 Jul 2026.