Rectus Abdominis Detrusor Myoplasty for Urinary Retention (RADM)

July 2, 2026 updated by: Shubham Gupta, University Hospitals Cleveland Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
6 Months and 1 Year Post-Op
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).
6 Months and 1 Year Post-Op
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.
6 Months and 1 Year Post-Op
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).
6 Months and 1 Year Post-Op
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).
6 Months and 1 Year Post-Op

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Month 6 and Year 1 Post-Op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospitals Cleveland Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shubham Gupta, MD, University Hospitals Cleveland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2036

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2036

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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