Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter

NCT01460303 | Completed Results

• 1 other identifier: H-13523
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief 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

Bladder Dysfunction; Urinary Retention

Keywords

Transurethral catheterization; Urinary retention; Bladder dysfunction; Patient comfort; Pelvic Reconstructive Surgery; Postoperative bladder dysfunction; Postoperative urinary retention

Outcome Measures

Primary Outcomes (1)

• Total Catheter Related Pain

  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.

  5-10 days postoperatively

Secondary Outcomes (1)

• Composite Satisfaction Score (CSS)

  5-10 days postoperatively

Study Arms (2)

OPTION-vf patient controlled catheter

EXPERIMENTAL

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.

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

Transurethral catheter w/leg bag

ACTIVE COMPARATOR

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.

Device: Transurethral catheter with leg bag

Interventions

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).

Also known as: OPTION-vf™ Valved Female Urinary Catheter, Patient Controlled Catheter

OPTION-vf 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).

Also known as: Foley catheter

Transurethral catheter w/leg bag

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• inability to provide consent
• \<18 years old
• non-English speaking
• patients using intermittent self-catheterization
• patients sustaining bladder injury during surgery
• prisoners
• pregnant women

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Michael K. Flynn
• Organization: UMass Medical School

Michael.Flynn@umassmemorial.org

Study Officials

• Michael Flynn, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: October 26, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 4, 2018
• Results First Posted: September 5, 2017

Record last verified: 2018-05