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Recruiting NCT07379814

Rectus Abdominis Detrusor Myoplasty for Urinary Retention

Observational Urinary Retention Urinary Retention After Procedure Urinary Retention Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rectus Abdominal Detrusor Myoplasty.
Who it may be relevant to
Registry conditions: Urinary Retention, Urinary Retention After Procedure, Urinary Retention Postoperative. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

To Investigate the Outcomes of Rectus Abdominis Flap Detrusor Myoplasty for Urinary Retention

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Change in quality of life as measured by the Short-Form 36 (SF-36) [Time frame: Month 6 and Year 1 Post-Op]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University Hospitals Cleveland Medical Center — Cleveland

Identifiers

NCT: NCT07379814 · STUDY20251303

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗