An interventional study of Catheter self-discontinuation in Urinary Retention, Pelvic Organ Prolapse and Stress Urinary Incontinence, sponsored by University of Texas at Austin. Recruiting at 4 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by University of Texas at Austin · Not applicable, Interventional, and Treatment
The goal of this randomized clinical trial is to determine if removal of transurethral urinary catheters by patients at home is as safe as catheter removal in the office following urogynecologic surgery.
Participants will be randomized to either standard catheter removal in the office or catheter self-removal at home.
This is a prospective, randomized, two-parallel arm, non-inferiority trial to evaluate two methods of catheter discontinuation in women with post-operative urinary retention (POUR) after surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI). This study will evaluate whether self-discontinuation of transurethral catheter by patients is non-inferior to standard office discontinuation based on rates of persistent POUR on post-operative day (POD) 1.
241 studies on the registry are indexed under Urinary Retention; 44 are open to participants now.
This study's planned enrollment of 118 is above the median of 90 across 187 interventional studies indexed under Urinary Retention.
Browse Urinary Retention studies →University of Texas at Austin is the lead sponsor of 328 studies on the registry; 79 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The patients randomized to the office-discontinuation group will visit the office for a repeat voiding trial on postoperative day 1. At this visit, the patients will undergo a backfill voiding trial.
The patients randomized to the catheter self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 1.
Procedure: Catheter self-discontinuation
Self-discontinuation of a transurethral catheter
Number of Participants With Postoperative Urinary Retention
Non-inferiority comparison of the rates of persistent POUR on POD1 between catheter self-discontinuation and standard office catheter. Persistent POUR is defined as PVR greater than 100 mL by bladder scan on POD1.
Time frame: Post-operative day 1
Rates of postoperative urinary tract infection (UTI)
Rates of postoperative UTI within 6 weeks of surgery - UTI will be defined as treatment with antibiotics for symptoms of UTI.
Time frame: within 6 weeks of surgery
Incidence of recurrent POUR
Recurrent POUR will be defined as any participant with successful POD1 voiding trial who later requires replacement of catheter due to recurrent POUR within 6 weeks of surgery. Recurrent POUR is defined as PVR greater than 100 mL by bladder scan after passing initial POD1 voiding trial.
Time frame: within 6 weeks of surgery
Number of postoperative patient encounters
Number of postoperative patient encounters, including any patient call to the office, electronic medical record message to office from patient, office visit, or emergency department visit.
Time frame: within 6 weeks of surgery
Patient satisfaction assessment via the Acceptability of Intervention Measure (AIM) Questionnaire
Patient satisfaction with catheter removal method as assessed via the Acceptability of Intervention Measure (AIM) Questionnaire. The AIM Questionnaire is a 4-item questionnaire on a 5-point Likert scale. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree Scoring Instructions: Scale is created by averaging responses. Scale values range from 1 to 5. The higher the score is, the higher the degree the patient finds the intervention acceptable.
Time frame: Post-operative day 1
Patient satisfaction assessment via the the Surgical Satisfaction Questionnaire - 8 (SSQ-8).
Patient satisfaction with catheter removal method as assessed via the Surgical Satisfaction Questionnaire - 8 (SSQ-8). The SSQ-8 is an 8-item questionnaire, with responses recorded on a 5-point Likert scale with responses from 0 "Very Unsatisfied" to 4 "Very Satisfied." Scoring uses the mean average of the 8 scores being multiplied by 25 (the questionnaire is considered incomplete if more than 2 items are not answered), yielding a potential range of scores from 0 to 100. The higher the score is, the greater the degree of surgical satisfaction.
Time frame: Post-operative day 1
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2023 (actual). Primary completion is estimated for Oct 2025, 26 months after the start.
Of 70 non-industry interventional studies with no phase under Urinary Retention, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 26 months is close to that.
Counting every sponsor, half of 82 studies reached it within 18 months; a quarter within 9 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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