Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter

Urinary Retention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460303
• Other study ID #: H-13523
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: December 2015

Study information

• Verified date: May 2018
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Dysfunction
• Urinary Retention

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Composite Satisfaction Score (CSS)	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.	5-10 days postoperatively