NCT03937531

Void Trials After Two Voiding Trials (TVT)

Comparison of Postoperative Voiding Dysfunction in Two Voiding Trials After Retropubic Midurethral Slings: a Randomized Controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this project is to compare the rate of postoperative voiding dysfunction in two voiding trials (the retrograde-fill technique versus the spontaneous-fill technique) after midurethral sling (MUS) procedures with tension-free vaginal tape (TVT) without any concomitant surgery.

Detailed description

The purpose of this research study is that the study investigators want to find out if there is a way of reducing patients' postoperative emotional stress from having a separate procedure to test their urinary function after "sling" surgery. Women with stress urinary incontinence (leakage of urine with physical activities like coughing, jumping, running, laughing, etc) may need "sling" surgery to help their urinary leakage problems. "Sling" surgeries in our hospital are mainly done using a retropubic midurethral sling (sling is passed to the space in front of your bladder). It is well known that having a sling surgery dramatically helps women with stress urinary incontinence. However, any surgical managements can have complications. One of the common complications from having a sling is "postoperative voiding dysfunction". In other words, some women may have a problem with urinating normally after the sling surgery. The most common problem is that some women (up to 4 out of 10 women) may not be able to urinate right after the surgery for the brief period of the time. The study team calls this condition "urinary retention". Postoperative urinary retention after the sling surgery can occur mainly due to pain, anesthesia effect, underlying tissue swelling; and rarely secondary to bleeding or nerve damage. Not being able to urinate for long time (\>6-8 hours) can damage the bladder muscle and nerves to the bladder. Therefore, most surgeons like to perform a "bladder testing" in the recovery unit before you are ready to go home to make sure you would be able to urinate at home once discharged. Traditionally, the bladder testing is involved with back-filling the bladder with sterile water (about 300cc) and checking if the patients are able to urinate within 30 minutes. The patients should be able to urinate about two thirds of amount that has been placed in the bladder. This "bladder testing" can create a lot of emotional stress to the patients; consequently, some of the patients may not be able to urinate within the given time although there is nothing wrong with their bladder function. Those patients, who did not pass this testing, are sent home with an indwelling urinary catheter with legbag until they come back to clinic for another "bladder testing" in 3-7 days. It is well known that the indwelling catheters are a leading cause of urinary tract infection and a source of patients' discomfort, embarrassment, and inconvenience. Therefore, this study is designed to find out if having a bladder test after the sling surgery is a really-must thing to perform to test the bladder function. The study team would like to investigate if allowing the patients to have enough time to urinate their own, without making them to go through the bladder testing, would be a sufficient way of testing the bladder function after sling surgery.

Conditions

• Postoperative Voiding Dysfunction
• Postoperative Urinary Retention

Interventions

Type	Name	Description
PROCEDURE	Bladder Scanner	PVR will be measured by using a bladder scanner.

Timeline

• Start date: 2020-02-01
• Primary completion: 2021-05-30
• Completion: 2022-05-30
• First posted: 2019-05-03
• Last updated: 2020-04-28

Locations

2 sites across 1 country: United States