[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07379814":3,"trial-entities:NCT07379814":105,"trial-summary:NCT07379814":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":54,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":15,"eligibility_criteria":62,"std_ages":77,"locations":80,"central_contacts":95,"overall_officials":98,"references":103,"see_also_links":104},"NCT07379814","STUDY20251303","Rectus Abdominis Detrusor Myoplasty for Urinary Retention","To Investigate the Outcomes of Rectus Abdominis Flap Detrusor Myoplasty for Urinary Retention","RECRUITING","2036-05-01","2026-07","2026-07-06","2026-05-01","University Hospitals Cleveland Medical Center","OTHER",false,"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","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.",[19,20,21],"Urinary Retention","Urinary Retention After Procedure","Urinary Retention Postoperative",[23],"urinary retention","OBSERVATIONAL",null,[],{"count":28,"type":29},50,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"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.",[36],"Individiuals receiving Rectus Abdominis Detrusor Myoplasty (RADM)",[38,42,45,48,51],{"measure":39,"description":40,"timeFrame":41},"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\u002Fcm H₂O).","6 Months and 1 Year Post-Op",{"measure":43,"description":44,"timeFrame":41},"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).",{"measure":46,"description":47,"timeFrame":41},"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.",{"measure":49,"description":50,"timeFrame":41},"Change in Urinary Flow Rate","Maximum urinary flow rate will be reported in milliliters per second (mL\u002Fs).",{"measure":52,"description":53,"timeFrame":41},"Change In Post-Void Residual Urine Volume in Urine","Post-void residual volume will be measured immediately following voiding and reported in milliliters (mL).",[55],{"measure":56,"description":57,"timeFrame":58},"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.","Month 6 and Year 1 Post-Op","ALL","18 Years","75 Years",{"inclusion":63,"exclusion":69,"raw_text":76},[64,65,66,67,68],"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\u002Fhypocontractility (i.e myogenic failure after chronic obstruction, aging, frailty, idiopathic)","Undergoing RADM",[70,71,72,73,74,75],"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 \\\u003C10 years","Pregnant at time of surgery","Inclusion Criteria:\n\n* Hypo- or acontractility of the bladder documented on urodynamic testing\n* Injury \\>1 year ago for spinal cord injury patients, no improvement in contractility with time\n* Failed sacral nerve stimulation implant for urinary retention treatment (If previously implanted)\n* Irreversible non-neurogenic bladder acontractility\u002Fhypocontractility (i.e myogenic failure after chronic obstruction, aging, frailty, idiopathic)\n* Undergoing RADM\n\nExclusion Criteria:\n\n* Documented bladder outlet obstruction\n* Spinal cord lesion above T12\n* Upper motor neuron lesion (i.e. multiple sclerosis, stroke)\n* Rectus diastasis, significant abdominal wall hernia, or other anatomic barrier to rectus flap harvest\n* Life expectancy \\\u003C10 years\n* Pregnant at time of surgery",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":13,"status":8,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":92},"Cleveland","Ohio","44106","United States",[87],{"name":88,"role":89,"phone":90,"email":91},"Seyed Tabei","CONTACT","216-844-8963","seyedsajjad.tabei@uhhospitals.org",{"lat":93,"lon":94},41.4995,-81.69541,[96],{"name":97,"role":89,"phone":90,"email":91},"Seyed Sajjad Tabei",[99],{"name":100,"affiliation":101,"role":102},"Shubham Gupta, MD","University Hospitals Cleveland","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":106,"biomarkers":107},[19],[],{"nct_id":4,"found":109,"summary":110,"prompt_version":119},true,{"design":111,"status":112,"heading":6,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is an observational study looking at the outcomes of a specific surgery. It plans to include 50 participants.","completed","This study is looking at a surgery called Rectus Abdominis Detrusor Myoplasty (RADM) for people with urinary retention, which means your bladder doesn't empty well. In this surgery, a part of your abdominal (belly) muscle is used to help your bladder squeeze and release urine. The study aims to see if this surgery improves how well your bladder works, specifically looking at bladder compliance (how much it can stretch), detrusor pressure (the pressure inside your bladder), and if detrusor overactivity (bladder muscle spasms) changes. You might be able to join if you are between 18 and 75 years old, have a bladder that doesn't contract well, and other treatments haven't worked. The study is currently unclear on its recruitment status and plans to enroll 50 participants.","Participants will be followed for 1 year after the surgery, with measurements taken at 6 months and 1 year.",126,"You would undergo the Rectus Abdominis Detrusor Myoplasty surgery. Your progress will be monitored for one year after the surgery.","Not stated in the trial record.",[],"v2"]