N/A
N=158
Self-discontinuation of a Transurethral Catheter
Postoperative Urinary Retention
Bottom Line
View on ClinicalTrials.gov: NCT02996968 ↗Enrolled (actual)
158
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Number of Participants With Postoperative Urinary Retention — 11; 11 Participants — p=0.5
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Self-removal (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- TriHealth Inc.
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Postoperative Urinary Retention |
11; 11 | 0.5 |
Summary
This study is to determine if self-discontinuation of transurethral foley catheters in patients diagnosed with postoperative urinary retention (POUR), which is defined as the continued need for catheterization, following impatient pelvic organ prolapse surgery is non-inferior to office-discontinuation.
Eligibility Criteria
Inclusion Criteria
- Undergoing vaginal vault suspension or robot-assisted laparoscopic sacrocolpopexy by a physician at Cincinnati Urogynecology Associates, TriHealth Inc.for the treatment of pelvic organ prolapse
- Failed voiding trial prior to discharge
- Concomitant procedures such as hysterectomy, suburethral sling, anterior or posterior colporrhaphy, bilateral salpingectomy or salpingooophorectomy
Exclusion Criteria
- physical or mental impairment that would affect the subject's ability to self-remove indwelling urinary catheter, including patient's with Multiple Sclerosis, Dementia, Parkinsonism, or those who have impaired mobility or are wheelchair bound
- Bladder injury, fistula repair or other need for prolonged catheterization
Data sourced from ClinicalTrials.gov (NCT02996968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.