Void Trials After Two Voiding Trials (TVT)

NCT03937531 | Withdrawn

• 1 other identifier: GCO 19-0816
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Voiding Dysfunction; Postoperative Urinary Retention

Keywords

Postoperative voiding dysfunction; Postoperative void trial; Retrograde fill void trial; Spontaneous void trial; Midurethral sling

Outcome Measures

Primary Outcomes (1)

• Void trial failure rates

  The void trial failure rates requiring postoperative urinary catheterization after midurethral sling procedures with transvaginal tape (TVT) without concomitant surgery. 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. PVR will be measured by both subtraction of the voided volume from 300cc and by using a bladder scanner.

  Day of surgery

Secondary Outcomes (6)

• Number of participants with Postoperative urinary retention (POUR)

  2 weeks and 6 weeks post surgery

• Time to discharge

  On the day of surgery

• Number of participants with Urinary tract infection

  Within 6 weeks after surgery

• Incontinence Severity Index (ISI)

  2 weeks and 6 weeks post surgery

• Urogenital Distress Inventory short form (UDI-6)

  2 weeks and 6 weeks post surgery

Study Arms (2)

Retrograde-fill void trial (RVT)

EXPERIMENTAL

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.

Procedure: Bladder Scanner

Spontaneous void trial (SVT)

ACTIVE COMPARATOR

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.

Procedure: Bladder Scanner

Interventions

Bladder Scanner PROCEDURE

PVR will be measured by using a bladder scanner.

Retrograde-fill void trial (RVT); Spontaneous void trial (SVT)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (2)

Mount Sinai West

New York, New York, 10019, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Related Publications (11)

• Rosseland LA, Stubhaug A, Breivik H. Detecting postoperative urinary retention with an ultrasound scanner. Acta Anaesthesiol Scand. 2002 Mar;46(3):279-82. doi: 10.1034/j.1399-6576.2002.t01-1-460309.x.

  PMID: 11939918 BACKGROUND

• Partoll LM. Efficacy of tension-free vaginal tape with other pelvic reconstructive surgery. Am J Obstet Gynecol. 2002 Jun;186(6):1292-5; discussion 1295-8. doi: 10.1067/mob.2002.123736.

  PMID: 12066111 BACKGROUND

• Tunitsky-Bitton E, Murphy A, Barber MD, Goldman HB, Vasavada S, Jelovsek JE. Assessment of voiding after sling: a randomized trial of 2 methods of postoperative catheter management after midurethral sling surgery for stress urinary incontinence in women. Am J Obstet Gynecol. 2015 May;212(5):597.e1-9. doi: 10.1016/j.ajog.2014.11.033. Epub 2014 Nov 27.

  PMID: 25434837 BACKGROUND

• Trautner BW, Darouiche RO. Catheter-associated infections: pathogenesis affects prevention. Arch Intern Med. 2004 Apr 26;164(8):842-50. doi: 10.1001/archinte.164.8.842.

  PMID: 15111369 BACKGROUND

• Barron KI, Savageau JA, Young SB, Labin LC, Morse AN. Prediction of successful voiding immediately after outpatient mid-urethral sling. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Nov;17(6):570-5. doi: 10.1007/s00192-005-0064-8. Epub 2006 Apr 1.

  PMID: 16583182 BACKGROUND

• Geller EJ. Prevention and management of postoperative urinary retention after urogynecologic surgery. Int J Womens Health. 2014 Aug 28;6:829-38. doi: 10.2147/IJWH.S55383. eCollection 2014.

  PMID: 25210477 BACKGROUND

• Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S3-9.

  PMID: 16985863 BACKGROUND

• Barber MD, Kleeman S, Karram MM, Paraiso MF, Walters MD, Vasavada S, Ellerkmann M. Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2008 Mar;111(3):611-21. doi: 10.1097/AOG.0b013e318162f22e.

  PMID: 18310363 BACKGROUND

• Dieter AA, Amundsen CL, Visco AG, Siddiqui NY. Treatment for urinary tract infection after midurethral sling: a retrospective study comparing patients who receive short-term postoperative catheterization and patients who pass a void trial on the day of surgery. Female Pelvic Med Reconstr Surg. 2012 May-Jun;18(3):175-8. doi: 10.1097/SPV.0b013e3182544e03.

  PMID: 22543772 BACKGROUND

• Yokoe DS, Anderson DJ, Berenholtz SM, Calfee DP, Dubberke ER, Ellingson KD, Gerding DN, Haas JP, Kaye KS, Klompas M, Lo E, Marschall J, Mermel LA, Nicolle LE, Salgado CD, Bryant K, Classen D, Crist K, Deloney VM, Fishman NO, Foster N, Goldmann DA, Humphreys E, Jernigan JA, Padberg J, Perl TM, Podgorny K, Septimus EJ, VanAmringe M, Weaver T, Weinstein RA, Wise R, Maragakis LL; Society for Healthcare Epidemiology of America (SHEA). A compendium of strategies to prevent healthcare-associated infections in acute care hospitals: 2014 updates. Infect Control Hosp Epidemiol. 2014 Aug;35(8):967-77. doi: 10.1086/677216.

  PMID: 25026611 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

Related Links

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

Study Officials

• Woojin Chong, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor & Assistant FPMRS Program Director

Model Details: 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).

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 3, 2019
• Study Start: February 1, 2020
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2022
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)