N/A
N=49
Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter
Bladder Dysfunction · Urinary Retention
Bottom Line
View on ClinicalTrials.gov: NCT01460303 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Total Catheter Related Pain — 1.25; 2.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag (Device); Transurethral catheter with leg bag (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Massachusetts, Worcester
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Catheter Related Pain |
1.25; 2.3 | — |
| SECONDARY Composite Satisfaction Score (CSS) |
2.23; 3.62 | — |
Summary
Following surgery for female urinary incontinence and/or pelvic organ prolapse, women are sometimes temporarily unable to empty their bladders and are sent home with a transurethral indwelling catheter attached to a bag which holds urine. The goal of this study is to compare a new type of patient-operated catheter without a bag to the catheter with a bag for ease of use, comfort and quality of life for patients during the postoperative recovery period. This new catheter, the OPTION-vf, is approved by the FDA and is available on the market.
Eligibility Criteria
Inclusion Criteria
- patients undergoing surgery for urinary incontinence and/or pelvic organ prolapse at the UMass Memorial Medical Center with one of the Urogynecology/Reconstructive Pelvic Surgery faculty.
Exclusion Criteria
- inability to provide consent
- <18 years old
- non-English speaking
- patients using intermittent self-catheterization
- patients sustaining bladder injury during surgery
- prisoners
- pregnant women
Data sourced from ClinicalTrials.gov (NCT01460303). 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.