Trials / Completed
CompletedNCT01460303
Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter
Clinical Trial of Patient Operated Valved Catheter Compared With Standard Indwelling Transurethral Catheter for Postoperative Bladder Management
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- University of Massachusetts, Worcester · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag | OPTION-vf patient controlled catheter (transurethral catheter with external drainage valve to provide on-demand drainage of urine stored directly from the bladder), worn maximum of 30 days post-op until bladder challenge is passed. Bladder challenge is considered "passed" when a patient is able to void adequately and spontaneously (without the assistance of a catheter). |
| DEVICE | Transurethral catheter with leg bag | Transurethral catheter w/leg bag urine storage, worn maximum of 30 days post-up until bladder challenge is passed. Bladder challenge is considered "passed" when a patient is able to void adequately and spontaneously (without the assistance of a catheter). |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2011-10-26
- Last updated
- 2018-05-04
- Results posted
- 2017-09-05
Source: ClinicalTrials.gov record NCT01460303. Inclusion in this directory is not an endorsement.