Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery

Surgery Clinical Trial

Official title: Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery

Status Recruiting

Clinical Trial Summary

This study is a randomized controlled trial designed to assess the rate of failure of voiding trials in the early and late post-operative period within patients who underwent outpatient pelvic floor surgery that failed initial same day voiding trials.

Clinical Trial Description

This study would be powered to detect differences in UTIs and Foley catheter re-insertion rates. Assuming a 10% drop-out rate, 100 total subjects should be enrolled in the study.

All patients that meet the appropriate inclusion criteria and are scheduled for outpatient pelvic floor surgery will be considered for the study. Patients will be counseled about the study either in the office during a surgical planning office visit, over a pre-operative telephone call, or in the pre-operative area just prior to surgery. Consents will be signed in the pre-operative area.

After surgery, the patient will be given a standardized voiding trial as per the usual protocol. If the patient is un-successful in emptying her bladder she will be discharged home with an indwelling Foley catheter with antibiotics. On post-operative day (POD) #1 the patient will be re-assessed for meeting eligibility requirements and will be called and randomized to either the early voiding trial group (EVT) or the late voiding trial group (LVT). Subjects in EVT will be scheduled for a repeat VT on POD#2, POD#3, or POD#4, whereas those in LVT will be scheduled for a repeat VT on or after POD#7. Subjects that are unsuccessful in the repeat VT will have a Foley catheter re-inserted and will return for another VT in 5-7 days. Subjects who fail the third VT from either group will have the Foley catheter replaced and will return for another office VT after waiting an additional 5-7 days or will be started on clean intermittent self-catheterization.

Subjects will be monitored for a 6 week period for voiding and urinary symptoms. Urine will be tested via in-office urinalysis at each office visit, including pre-operatively, and will be sent for a urine culture per usual practice based upon abnormal urinalysis results. Urine cultures that grow out a single organism >10,000 CFU will be treated with appropriate antibiotics. In addition, patients will complete quality of life questionnaires at the time of catheter removal, the standard 2 week post-op visit and at 6weeks post-operatively. ;

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Surgery
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress

• NCT number: NCT03048682
• Study type: Interventional
• Source: The Cleveland Clinic
• Contact: Jeffrey Schachar, MD
• Phone: 954-569-5559
• Email: SchachJ@ccf.org
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2017
• Completion date: January 30, 2020