Urinary Retention, Urinary Retention After Procedure, Urinary Retention Postoperative
Conditions
Keywords
urinary retention
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
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
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.
Sponsors
University Hospitals Cleveland Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bladder Compliance | 6 Months and 1 Year Post-Op | 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). |
| Change in Detrusor Pressure | 6 Months and 1 Year Post-Op | Detrusor pressure during filling and voiding, including detrusor pressure at maximum flow, will be reported in centimeters of water (cm H₂O). |
| Change in presence of Detrusor Overactivity | 6 Months and 1 Year Post-Op | Detrusor overactivity will be recorded as a binary variable (present or absent) based on the occurrence of involuntary detrusor contractions during filling. |
| Change in Urinary Flow Rate | 6 Months and 1 Year Post-Op | Maximum urinary flow rate will be reported in milliliters per second (mL/s). |
| Change In Post-Void Residual Urine Volume in Urine | 6 Months and 1 Year Post-Op | Post-void residual volume will be measured immediately following voiding and reported in milliliters (mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life as measured by the Short-Form 36 (SF-36) | Month 6 and Year 1 Post-Op | 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. |
Countries
United States
Contacts
CONTACTSeyed Sajjad Tabei
PRINCIPAL_INVESTIGATORShubham Gupta, MD
University Hospitals Cleveland
Outcome results
None listed