Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter
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ClinicalTrials.gov Identifier: NCT01460303 |
Recruitment Status :
Completed
First Posted : October 26, 2011
Results First Posted : September 5, 2017
Last Update Posted : May 4, 2018
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Condition or disease | Intervention/treatment | Phase |
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Bladder Dysfunction Urinary Retention | Device: Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag Device: Transurethral catheter with leg bag | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 49 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clinical Trial of Patient Operated Valved Catheter Compared With Standard Indwelling Transurethral Catheter for Postoperative Bladder Management |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
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Experimental: OPTION-vf patient controlled catheter
Patients who fail postop bladder challenge and are randomized to "OPTION-vf" arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge.
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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).
Other Names:
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Active Comparator: Transurethral catheter w/leg bag
Patients who fail postop bladder challenge and are randomized to "indwelling catheter with leg bag" arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge.
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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).
Other Name: Foley catheter |
- Total Catheter Related Pain [ Time Frame: 5-10 days postoperatively ]Total Catheter Related Pain Range Scale (0 = none, to 10 = worst) on the Post Operative Questionnaire All subjects were given and appointment for an outpatient voiding trial after hospital discharge. The Post Operative questionnaire was completed by the subject one time at that appointment.
- Composite Satisfaction Score (CSS) [ Time Frame: 5-10 days postoperatively ]
The mean scores for the first 5 questions of the Post Operative Questionnaire were used to calculate a Composite Satisfaction Score.
- Total Pain (0 none, 10 worst)
- Total Catheter Related Pain Range Scale (0 none, 10 worst)
- Ease of catheter use (0 easy, 10 difficult)
- Feeling of frustration (0 none, 10 very much)
- Limited social activities (0 none, 10 very much) All subjects were given and appointment for an outpatient voiding trial after hospital discharge. The Post Operative Questionnaire was completed by the subject one time at that appointment.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460303
Principal Investigator: | Michael Flynn, MD | University of Massachusetts, Worcester |
Responsible Party: | Michael Flynn, Principal Investigator, University of Massachusetts, Worcester |
ClinicalTrials.gov Identifier: | NCT01460303 |
Other Study ID Numbers: |
H-13523 |
First Posted: | October 26, 2011 Key Record Dates |
Results First Posted: | September 5, 2017 |
Last Update Posted: | May 4, 2018 |
Last Verified: | May 2018 |
Transurethral catheterization Urinary retention Bladder dysfunction Patient comfort |
Pelvic Reconstructive Surgery Postoperative bladder dysfunction Postoperative urinary retention |
Urinary Retention Urination Disorders Urologic Diseases |