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Rectus Abdominis Detrusor Myoplasty for Urinary Retention (RADM)

University Hospitals (UH) logo

University Hospitals (UH)

Status

Begins enrollment in 2 months

Conditions

Urinary Retention Postoperative
Urinary Retention
Urinary Retention After Procedure

Treatments

Procedure: Rectus Abdominal Detrusor Myoplasty

Study type

Observational

Funder types

Other

Identifiers

NCT07379814
STUDY20251303

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Individiuals receiving Rectus Abdominis Detrusor Myoplasty (RADM)
Description:
Individuals diagnosed with refractory urinary retention that have failed conventional approaches to treat urinary retention such as catheterization and neurostimulation.
Treatment:
Procedure: Rectus Abdominal Detrusor Myoplasty

Trial contacts and locations

0

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Central trial contact

Seyed Sajjad Tabei

Data sourced from clinicaltrials.gov

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