Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter

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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Key information

Conditions

Bladder Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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).

Other names: OPTION-vf™ Valved Female Urinary Catheter, Patient Controlled Catheter

Transurethral catheter with leg bag

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).

Other names: Foley catheter

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

Clinical Trial of Patient Operated Valved Catheter Compared With Standard Indwelling Transurethral Catheter for Postoperative Bladder Management

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Oct 26, 2011
Registry last updated: May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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