Void Trials After Two Voiding Trials (TVT)

Postoperative Urinary Retention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03937531
• Other study ID #: GCO 19-0816
• Status: Withdrawn
• Phase: N/A
• Start date: February 2020
• Est. completion date: May 30, 2022

Study information

• Verified date: April 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Urinary Retention
• Postoperative Voiding Dysfunction
• Urinary Retention

Intervention

Procedure:
• Bladder Scanner
PVR will be measured by using a bladder scanner.

Locations

Country	Name	City	State
United States	Mount Sinai Medical Center	New York	New York
United States	Mount Sinai West	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. Epub 2006 Apr 1. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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

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. — View Citation

Rosseland LA, Stubhaug A, Breivik H. Detecting postoperative urinary retention with an ultrasound scanner. Acta Anaesthesiol Scand. 2002 Mar;46(3):279-82. — View Citation

Trautner BW, Darouiche RO. Catheter-associated infections: pathogenesis affects prevention. Arch Intern Med. 2004 Apr 26;164(8):842-50. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with Postoperative urinary retention (POUR)	POUR any time up to 6 weeks after surgery: after discharge, subjects will be monitored for any encounters for POUR and will be asked at 2 weeks and 6 weeks post-operative visit if they have had a catheter placed outside the hospital. Additionally, any subject who fails their 2nd void trial will be noted.	2 weeks and 6 weeks post surgery
Secondary	Time to discharge	Time to discharge will be determined by calculating the time between arrival to the PACU and the time of discharge using documentation from EPIC. Time to discharge is expected to happen on the day of surgery regardless of success or failure of void trial.	On the day of surgery
Secondary	Number of participants with Urinary tract infection	UTI any time up to 6 weeks after surgery: subjects with a culture-proven UTI or >= 2 urinary symptoms (urinary urgency, frequency, dysuria, suprapubic pain, foul-smelling urine) plus pyuria on urine dip or urine analysis will be noted. Antibiotic treatment will be noted.	Within 6 weeks after surgery
Secondary	Incontinence Severity Index (ISI)	ISI total scored from 0-12, with higher score indicating more severity of symptoms.	2 weeks and 6 weeks post surgery
Secondary	Urogenital Distress Inventory short form (UDI-6)	UDI-6 is a 6 -item questionnaire, each item scored 0-3 with total score from 0 to 0 to 75, with higher score indicating more distress.	2 weeks and 6 weeks post surgery
Secondary	Patient Global Impression of Improvement (PGI-I)	PGI-I is scored on a 7 likert score, with total score from 1 to 7, with higher score indicating worse outcome	2 weeks and 6 weeks post surgery

External Links

•   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.
•   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