- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10019
- Mount Sinai West
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New York, New York, United States, 10029
- Mount Sinai Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
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PVR will be measured by using a bladder scanner.
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ACTIVE_COMPARATOR: 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. |
PVR will be measured by using a bladder scanner.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Void trial failure rates
Time Frame: Day of surgery
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with Postoperative urinary retention (POUR)
Time Frame: 2 weeks and 6 weeks post surgery
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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.
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2 weeks and 6 weeks post surgery
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Time to discharge
Time Frame: On the day of surgery
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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.
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On the day of surgery
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Number of participants with Urinary tract infection
Time Frame: Within 6 weeks after surgery
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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.
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Within 6 weeks after surgery
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Incontinence Severity Index (ISI)
Time Frame: 2 weeks and 6 weeks post surgery
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ISI total scored from 0-12, with higher score indicating more severity of symptoms.
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2 weeks and 6 weeks post surgery
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Urogenital Distress Inventory short form (UDI-6)
Time Frame: 2 weeks and 6 weeks post surgery
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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.
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2 weeks and 6 weeks post surgery
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Patient Global Impression of Improvement (PGI-I)
Time Frame: 2 weeks and 6 weeks post surgery
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PGI-I is scored on a 7 likert score, with total score from 1 to 7, with higher score indicating worse outcome
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2 weeks and 6 weeks post surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Woojin Chong, MD, Icahn School of Medicine at Mount Sinai
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S3-9.
- 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.
Helpful 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 record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 19-0816
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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