Early Versus Late Voiding Trials After Prolapse Repair

Sponsor

University of Pittsburgh (Other)

Overall Status

Terminated

CT.gov ID

NCT02739256

Collaborator

(none)

Enrollment

Location

Arms

12.9

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary aim of this study is to determine if normal bladder function (the ability to empty the bladder during spontaneous urination) after surgical repair of pelvic organ prolapse returns faster in patients who have a retrograde voiding trial the day of surgery versus patients who have a retrograde voiding trial on postoperative day one. Half of participants will have a voiding trial 4 hours after surgery, while the other half will have the voiding trial postoperative day one.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention Pelvic Organ Prolapse	Procedure: Retrograde voiding trial	N/A

Detailed Description

Overnight indwelling catheterization is a prevalent practice after surgical repair of pelvic organ prolapse. A voiding trial is performed postoperative day one to determine if urinary retention or abnormal bladder function exists. A significant number of patients ranging from 26-47% will require continued catheterization post-op for urinary retention in order to avoid injuries associated with over distention of the bladder and ureteral reflux.

This study aims to explore a strategy to reduce the length of catheterization post-operatively by testing the bladder at a closer interval to surgery. An earlier voiding trial may improve patient perioperative satisfaction and decrease catheter associated urinary tract infections. Additional benefits that may also be seen are earlier first ambulation and quicker achievement of post-op discharge milestones (pain control, ambulation with symptoms, oral intake tolerance and completion of a voiding trial). To date, few studies have attempted a day of surgery voiding trial in patients being admitted for repair of pelvic organ prolapse that requires an overnight admission.

Study Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

Normal Voiding Function After Surgical Repair of Pelvic Organ Prolapse: A Randomized Trial Comparing Day of Surgery Retrograde Void Trials to Standard Postoperative Day One Retrograde Void Trials

Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: voiding trial 4 hours post-op	Procedure: Retrograde voiding trial A bladder test is performed after surgery for prolapse to make sure the patient can empty their bladder prior to discharge from the hospital. The test consists of filling the bladder with 300 mL of water and removing the catheter. Then the patient voids. Other Names: Bladder Test
Active Comparator: voiding trial post-op day 1	Procedure: Retrograde voiding trial A bladder test is performed after surgery for prolapse to make sure the patient can empty their bladder prior to discharge from the hospital. The test consists of filling the bladder with 300 mL of water and removing the catheter. Then the patient voids. Other Names: Bladder Test

Arm

Intervention/Treatment

Experimental: voiding trial 4 hours post-op

Procedure: Retrograde voiding trial

A bladder test is performed after surgery for prolapse to make sure the patient can empty their bladder prior to discharge from the hospital. The test consists of filling the bladder with 300 mL of water and removing the catheter. Then the patient voids.

Other Names:

Bladder Test

Active Comparator: voiding trial post-op day 1

Procedure: Retrograde voiding trial

Other Names:

Bladder Test

Outcome Measures

Primary Outcome Measures

time to return of normal bladder function [5 days]

Secondary Outcome Measures

time to first ambulation [24 hours]
anxiety level [24 hours]
The State-Trait Anxiety Index anxiety inventory will be administered pre-operatively and at 4 different time point post-operatively to assess the patient's level of anxiety related to the catheter
pain level [24 hours]
A pain scale will be administered pre-operatively and at 4 different time point post-operatively to assess the patient's level of anxiety related to the catheter
patient preference in the timing of the voiding trial [24 hours]
a brief survey will be given 4 times during the hospital admission assess this
catheter associated urinary tract infections [6 weeks]
medical records will be reviewed after discharge from the hospital for positive urine cultures

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

surgical management of pelvic organ prolapse requiring an overnight hospital admission

Exclusion Criteria:

same day surgery
non-ambulatory (allowed to use an assistive device)
inability to provide informed consent, age < 21 years
pregnancy or desire for future pregnancy
systematic disease known to affect bladder function (Parkinson's disease, Multiple Sclerosis, Spina Bifida, spinal cord injury or trauma and neurogenic bladder)
known preoperative urinary retention (defined as a post-void residual > 100mL)
an untreated urinary tract infection at the time of surgery
treatment at the time of surgery for urinary tract infection
symptoms of urinary tract infection on the day of surgery