Recruiting

Surgical Technique

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT07379814

Conditions

Urinary Retention

Urinary Retention After Procedure

Urinary Retention Postoperative

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Rectus Abdominal Detrusor Myoplasty

Study Details

Brief 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

Conditions

Urinary Retention

Urinary Retention After Procedure

Urinary Retention Postoperative

Study ID

NCT07379814

Start date

May 1, 2026

Status verified date

Jul, 2026

Completion date

May 1, 2036

Anticipated

Primary completion date

May 1, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Change in Bladder Compliance [ Time Frame: 6 Months and 1 Year Post-Op ]
  • Change in Detrusor Pressure [ Time Frame: 6 Months and 1 Year Post-Op ]
  • Change in presence of Detrusor Overactivity [ Time Frame: 6 Months and 1 Year Post-Op ]
  • Change in Urinary Flow Rate [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Seyed Sajjad Tabei

216-844-8963seyedsajjad.tabei@uhhospitals.org

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Seyed Tabei

216-844-8963seyedsajjad.tabei@uhhospitals.org

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • urinary retention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-07-06.