Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bladder Dysfunction Urinary Retention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag

Intervention Type DEVICE

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).

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.

Group Type ACTIVE_COMPARATOR

Transurethral catheter with leg bag

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type 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).

Intervention Type DEVICE

Other Intervention Names

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OPTION-vf™ Valved Female Urinary Catheter Patient Controlled Catheter Foley catheter

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No