Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter

University of Massachusetts, Worcester

Status: Completed

Conditions: Urinary Retention; Bladder Dysfunction

Treatments: Device: Transurethral catheter with leg bag; Device: Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag

Study type: Interventional

Funder types: Other

Identifiers

NCT01460303

H-13523

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

OPTION-vf patient controlled catheter

Experimental group

Description:

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.

Treatment:

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

Transurethral catheter w/leg bag

Active Comparator group

Description:

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.

Treatment:

Device: Transurethral catheter with leg bag