Comparing Voiding Trials After Midurethral Sling for Stress Incontinence

Study Overview
=================
Brief Summary
-----------------
Urinary incontinence is a prevalent health and quality of life concern affecting almost half of women over the age of 20. Urinary retention (abnormal holding of urine) is a concern of many surgeons who perform midurethral sling surgery. All patients after outpatient midurethral sling or vaginal prolpase surgery must complete a voiding trial if they are to be discharged without a catheter. The purpose of this study is to compare two different types of postoperative voiding trials to determine which leads to less post-operative issues, such as urinary retention requiring catheterization. You are being asked to participate because you are having midurethral sling surgery, either with or without vaginal prolapse repair.

Detailed Description
-----------------
Urinary incontinence is a prevalent health and quality of life concern affecting an estimated 49.6% of women over the age of 20 years in the USA. (1) Of these, 49.8% describe pure stress urinary incontinence (SUI) and 34.3% report mixed stress and urgency urinary incontinence. (1) Midurethral sling (MUS) surgery is used to treat women with SUI, but accepted protocols for voiding trials after midurethral sling placement do not exist. Primarily, many surgeons measure postvoid residual (PVR) urine volume. This is done by retrograde filling of the bladder with a predetermined amount of normal saline or water. The catheter is then removed and the patient is permitted to void into a collection basin. The amount in the basin is subtracted from the filled amount. The need for catheterization is generally based on arbitrarily determined ratios of voided urine to PVR or postoperative. The acceptable amount voided during catheterization varies among practitioners. In a study by Kleeman et al, the patient was required to void >50% of volume filled during retrograde fill for discharge from hospital without an indwelling Foley catheter (2). Pulvino et al, required that the patient void > 2/3 the amount of the volume placed during retrograde fill (3). The force of stream trial (FAST) does not prioritize amount voided, but rather the patient's subjective force of stream. The bladder is retrograde filled with 300cc normal saline or water and the patient is instructed to void.. Using FAST, a patient uses a VAS scale to quantify her force of stream. If she states that her Force of Stream (FOS) is >50% stronger than prior to surgery, independent of the amount voided, she is discharged without a catheter. If the FOS is <50% a PVR via bladder scan is performed. If her PVR is <500cc the patient was discharged home without a catheter in place. If the PVR, via bladder scan was > 500cc she was discharged with a catheter. Ingber et. Al. showed the FAST method was a safe method for predicting postoperative voiding dysfunction and/or urinary retention. No patients presented to the office or emergency room for voiding dysfunction or urinary retention (4). Urinary retention is a concern of many surgeons who perform midurethral sling surgery; 25% of urologists routinely discharge patients home with a catheter and 31% admit patients overnight or for 23 hour observation, with 42% doing so for the primary purpose of facilitating the voiding trial. (5) Published catheterization rates for these protocols can approach 39%. (6,7) Temporary catheterization does not pose a significant medical risk, but it is perceived as an inconvenience and source of discomfort for many patients. Proper care of an indwelling foley catheter requires extra teaching from nursing and/or house staff. No randomized control trials (RCT) have been performed comparing the FAST method to the traditional retrograde voiding trial. In our practice we assess postoperative voiding function using the retrograde fill with 300cc saline or water. We also require a 2/3 quantity voided for discontinuation of catheter. All patients after outpatient midurethral sling or vaginal prolpase surgery must complete a voiding trial if they are to be discharged without a catheter. This is standard of care and followed in our practice. We would like to compare both postoperative voiding trials in patients who have undergone surgical repair concomitant midurethral sling with or without anterior colporrhaphy. We will include those patients who also had an anterior colporrhaphy at time of sling placement as this procedure is commonly performed at the time of sling placement for stablization of MUS. We will assess the number of emergent or unexpected visits for voiding dysfunction. An unexpected visit to the office will be defined as any visit outside of the patient's prior scheduled postoperative visits.

Official Title
-----------------
A Randomized Controlled Trial Comparing Force of Stream to Traditional Retrograde Fill Voiding Trial After Midurethral Sling With or Without Vaginal Prolapse Surgery

Conditions
-----------------
Stress Urinary Incontinence, Urethral Hypermobility, Cystocele

Intervention / Treatment
-----------------
* Other: Voiding trial


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postoperative patients after placement of midurethral sling (retropubic sling or transobturator) with or without anterior or posterior colporrhaphy. Ability to provide informed consent and complete all study requirements Exclusion Criteria: Patients who underwent a surgery that requires long term catheterization (i.e fistula repair or urethral diverticulum) Patients who sustained a cystotomy during surgery as our divisional protocol is to send these patients home with a Foley catheter for 5-14 days without a voiding trial Patients who had an apical repair for pelvic organ prolapse (Uterosacral vaginal vault suspension, Abdominal sacral colpopexy, sacrospinous ligament fixation)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FAST voiding trial method<br>1) Bladder drained with indwelling foley catheter, then retrograde filled with 300cc sterile water. 2) catheter is removed; 3) Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). 4) The patient will subjectively quantify their FOS via VAS scale. 5) If VAS scale >50 (=50%) the catheter will remain out, patient is discharged home without measuring a PVR 6) If VAS scale is from 0-49 (= 0-49%) a PVR will be checked via bladder scan. If PVR is <500 the patient will be discharged WITHOUT a catheter; If PVR is >500 the patient will be discharged WITH a catheter. If she is discharged with an indwelling foley catheter, she will have an in-office retrograde voiding trial in 2-5 days | Other: Voiding trial<br>* 1 of 2 tests to assess bladder function after midurethral sling surgery with and without anterior or posterior colporrhaphy<br>* Other names: voiding;|
| Active Comparator: Retrograde fill voiding trial method<br>1) Bladder drained with indwelling foley catheter, then retrograde filled with 300cc sterile water. 2) catheter is removed; 3) Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). 4) The patient will subjectively quantify their FOS via VAS scale (however this information will only be used for research purposes). 5) If she voids >/= 2/3 (200cc) the catheter will remain out as she will have passed her voiding trial. If she voids < 200cc she will be discharged home with a catheter and instructed to follow-up in 2-5 days for an in-office retrograde voiding trial in 2-5 days. | Other: Voiding trial<br>* 1 of 2 tests to assess bladder function after midurethral sling surgery with and without anterior or posterior colporrhaphy<br>* Other names: voiding;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of emergency room visits or unexpected visits to the office within 6 weeks postoperatively for voiding dysfunction or suspected infection | Any additional visit outside the patient's scheduled postoperative visits to the emergency room, urgent care facility or doctor's office will be recorded for up to 6 six weeks postoperatively | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients sent home with a catheter | the number of patients in each arm who are sent home with a catheter will be recorded | 6 weeks | 
| Number of patients with reported UTI |  | 6 weeks | 
| Time to discharge from hospital | Time upon arrival to Post Anesthesia Care Unit to discharge to home will be calculated for each arm | 6 weeks | 
| Patient satisfaction with postoperative bladder function | American Urological Association Symptom Score (AUASS); Urinary Distress Inventory (UDI-6) | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
midurethral sling, Voiding trial, stress urinary incontinence