Void Trials After Two Voiding Trials (TVT)

NCT ID: NCT03937531

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-29
• Study Completion Date: 2022-05-30

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.

Conditions

Postoperative Voiding Dysfunction; Postoperative Urinary Retention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Retrograde-fill void trial (RVT)

Subjects will leave the operating room with a urinary catheter inserted. Subjects should be recovered from anesthesia effects (2-3 hours after surgery) before voiding trial. First, the bladder will be completely drained into the Foley bag then the bag will be detached from the catheter. The bladder will be back-filled with sterile water (300 mL). After the catheter is removed, subjects are expected to void at least 2/3 (200 mL) of the total instilled amount within 30 minutes of filling. Post-void residual (PVR) will be measured by both subtraction of the voided volume from 300cc and by using a bladder scanner.

Group Type: EXPERIMENTAL

Bladder Scanner

Intervention Type: PROCEDURE

PVR will be measured by using a bladder scanner.

Spontaneous void trial (SVT)

Subjects will leave the operating room without a urinary catheter. Participants are allowed up to 6 hours after surgery for spontaneous voiding. After voiding, the voided volume will be noted. PVR will be measured using a bladder scanner.

In both groups, if PVR >=100 mL on a bladder scanner, an indwelling urinary catheter will be placed and the actual PVR will be documented. Subjects who failed voiding trial will be instructed to return to clinic within 2-4 days for the second void trial. Prophylactic antibiotics will NOT be given. The time to discharge will be measured for each subject. This will be determined by calculating the time between arrival to the PACU and the time of discharge using documentation from EPIC.

Group Type: ACTIVE_COMPARATOR

Bladder Scanner

Intervention Type: PROCEDURE

PVR will be measured by using a bladder scanner.

Interventions

Bladder Scanner

PVR will be measured by using a bladder scanner.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Woojin Chong-Kaufman

Assistant Professor & Assistant FPMRS Program Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Woojin Chong, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai West

New York, New York, United States

Mount Sinai Medical Center

New York, New York, United States

Countries

United States

References

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Related Links

http://dx.doi.org/10.1016/j.ajog.2009.01.007

Oliphant SS, Wang L, Bunker CH, Lowder JL. Trends in stress urinary incontinence inpatient procedures in the United States, 1979-2004. Am J Obstet Gynecol. 2009; 200: 521.e1-521.e6

https://www.ics.org/Abstracts/Publish/106/000848.pdf

EL-Hefnawy A, Wadie B, Abed A, Nabeeh A. Post-operative complications of midurethral slings: is it possible to use Clavien's classification? \[ICS Abstract 848\].

https://doi.org/10.1016/S0002-9378(03)00932-3

Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L. Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol. 2003; 189: 1551-1558.

Other Identifiers

GCO 19-0816

Identifier Type: -

Identifier Source: org_study_id