NCT07379814

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
122mo left

Started May 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2036

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2036

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

10 years

First QC Date

January 23, 2026

Last Update Submit

January 23, 2026

Conditions

Urinary RetentionUrinary Retention After ProcedureUrinary Retention Postoperative

Keywords

urinary retention

Outcome Measures

Primary Outcomes (5)

  • 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).

    6 Months and 1 Year Post-Op

  • 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).

    6 Months and 1 Year Post-Op

  • 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.

    6 Months and 1 Year Post-Op

  • Change in Urinary Flow Rate

    Maximum urinary flow rate will be reported in milliliters per second (mL/s).

    6 Months and 1 Year Post-Op

  • Change In Post-Void Residual Urine Volume in Urine

    Post-void residual volume will be measured immediately following voiding and reported in milliliters (mL).

    6 Months and 1 Year Post-Op

Secondary Outcomes (1)

  • Change in quality of life as measured by the Short-Form 36 (SF-36)

    Month 6 and Year 1 Post-Op

Study Arms (1)

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.

Procedure: Rectus Abdominal Detrusor Myoplasty

Interventions

Rectus Abdominal Detrusor MyoplastyPROCEDURE

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.

Individiuals receiving Rectus Abdominis Detrusor Myoplasty (RADM)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals diagnosed with refractory urinary retention undergoing RADM

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Shubham Gupta, MD

    University Hospitals Cleveland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyed Sajjad Tabei

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 23, 2026

First Posted

January 30, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2036

Study Completion (Estimated)

May 1, 2036

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share