ClinicalTrials.gg
RecruitingNCT07379814RADMUpdated Jul 6, 2026

Rectus Abdominis Detrusor Myoplasty for Urinary Retention

An observational study in Urinary Retention, Urinary Retention After Procedure and Urinary Retention Postoperative, sponsored by University Hospitals Cleveland Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by University Hospitals Cleveland Medical Center · Observational

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Urinary Retention
  • Urinary Retention After Procedure
  • Urinary Retention Postoperative

Browse trials for

Keywords

  • urinary retention
03

In context

Urinary Retention

241 studies on the registry are indexed under Urinary Retention; 44 are open to participants now.

This study's planned enrollment of 50 is below the median of 116 across 45 observational studies indexed under Urinary Retention.

Browse Urinary Retention studies →

Lead sponsor

University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals diagnosed with refractory urinary retention undergoing RADM

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • \<10 years
  • Pregnant at time of surgery
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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

Interventions

  • ProcedureRectus 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 6 Months and 1 Year Post-Op

  2. 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).

    Time frame: 6 Months and 1 Year Post-Op

  3. 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.

    Time frame: 6 Months and 1 Year Post-Op

  4. Change in Urinary Flow Rate

    Maximum urinary flow rate will be reported in milliliters per second (mL/s).

    Time frame: 6 Months and 1 Year Post-Op

  5. Change In Post-Void Residual Urine Volume in Urine

    Post-void residual volume will be measured immediately following voiding and reported in milliliters (mL).

    Time frame: 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.

    Time frame: Month 6 and Year 1 Post-Op

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07379814
Responsible party
Shubham Gupta (Professor, University Hospitals Cleveland Medical Center) — Principal investigator
First posted
Jan 30, 2026
Start date
May 1, 2026
Primary completion
May 1, 2036 (estimated)
Completion
May 1, 2036 (estimated)
Last update
Jul 6, 2026

Study contacts

Seyed Sajjad Tabei
Contact
seyedsajjad.tabei@uhhospitals.org
216-844-8963
Shubham Gupta, MD
principal investigator · University Hospitals Cleveland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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