Rectus Abdominis Detrusor Myoplasty for Urinary Retention
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUniversity Hospitals Cleveland Medical Center
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Individuals diagnosed with refractory urinary retention undergoing RADM
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Rectus Abdominal Detrusor Myoplasty
Procedure/SurgeryIn 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Individiuals receiving Rectus Abdominis Detrusor Myoplasty (RADM)1 intervention
Trial outcomes
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-Op2
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-Op3
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-Op4
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-OpSecondary 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-OpSponsors and contacts
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Source ClinicalTrials.gov