Clinical trial NCT03937531: Void Trials After Two Voiding Trials (TVT)
Official title: Comparison of Postoperative Voiding Dysfunction in Two Voiding Trials After Retropubic Midurethral Slings: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postoperative Voiding Dysfunction
Postoperative Urinary Retention
Keywords: Postoperative voiding dysfunction
Postoperative void trial
Retrograde fill void trial
Spontaneous void trial
Midurethral sling
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be enrolled consecutively during either the surgical preoperative evaluation or in the preoperative holding area before surgery. Participation in the study would not alter their surgical treatment plan. Randomization will be determined through computer-generated random number blocks of six. A sequentially numbered, opaque, sealed envelope will be opened for each subject after the recruitment and consenting process, and subjects will be assigned to one of two groups: retrograde fill void trial (RVT) vs spontaneous void trial (SVT).
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Any adult female (age \>= 18 years old) undergoing an outpatient TVT surgery for SUI will be eligible for participation.
* Participants must be able to provide informed consent and complete all study requirements.

Exclusion Criteria:

* Participants will be excluded if the surgery involves any concomitant urinary tract or pelvic reconstructive procedure or if the procedure, in itself, necessitates PUC, as in the event of a cystotomy, bladder perforation or intraoperative hemorrhage
* Participants with a history of neurologic conditions affecting the urinary tract system, POP beyond the hymen during straining (any compartment), or previous anti-incontinence procedure will be also excluded.

Primary outcomes:
measure: Void trial failure rates
timeFrame: Day of surgery
Secondary outcomes:
measure: Number of participants with Postoperative urinary retention (POUR)
timeFrame: 2 weeks and 6 weeks post surgery
measure: Time to discharge
timeFrame: On the day of surgery
measure: Number of participants with Urinary tract infection
timeFrame: Within 6 weeks after surgery
measure: Incontinence Severity Index (ISI)
timeFrame: 2 weeks and 6 weeks post surgery
measure: Urogenital Distress Inventory short form (UDI-6)
timeFrame: 2 weeks and 6 weeks post surgery
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: 2 weeks and 6 weeks post surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai West
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Woojin Chong, MD
role: PRINCIPAL_INVESTIGATOR
References:
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