N/A
Completed N=49
Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter
Bladder Dysfunction · Urinary Retention
Source: ClinicalTrials.gov NCT01460303 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Total Catheter Related Pain — 1.25; 2.3 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Catheter Related Pain |
1.25; 2.3 | — |
| SECONDARY Composite Satisfaction Score (CSS) |
2.23; 3.62 | — |
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. Informational only — not medical advice.