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出境医 / 临床实验 / Void Trials After Two Voiding Trials (TVT)

Void Trials After Two Voiding Trials (TVT)

Study Description
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.

Condition or disease Intervention/treatment Phase
Postoperative Voiding Dysfunction Postoperative Urinary Retention Procedure: Bladder Scanner Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of Postoperative Voiding Dysfunction in Two Voiding Trials After Retropubic Midurethral Slings: a Randomized Controlled Trial
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2022
Arms and Interventions
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.
 Procedure: Bladder Scanner
PVR will be measured by using a bladder scanner.
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.

 Procedure: Bladder Scanner
PVR will be measured by using a bladder scanner.
Outcome Measures
Primary Outcome Measures :
  1. Void trial failure rates [ Time Frame: Day of surgery ]

    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.



Secondary Outcome Measures :
  1. Number of participants with Postoperative urinary retention (POUR) [ Time Frame: 2 weeks and 6 weeks post surgery ]
    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. Time to discharge [ Time Frame: On the day of surgery ]
    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.

  3. Number of participants with Urinary tract infection [ Time Frame: Within 6 weeks after surgery ]
    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.

  4. Incontinence Severity Index (ISI) [ Time Frame: 2 weeks and 6 weeks post surgery ]
    ISI total scored from 0-12, with higher score indicating more severity of symptoms.

  5. Urogenital Distress Inventory short form (UDI-6) [ Time Frame: 2 weeks and 6 weeks post surgery ]
    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.

  6. Patient Global Impression of Improvement (PGI-I) [ Time Frame: 2 weeks and 6 weeks post surgery ]
    PGI-I is scored on a 7 likert score, with total score from 1 to 7, with higher score indicating worse outcome


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Locations
Layout table for location information
United States, New York
Mount Sinai West
New York, New York, United States, 10019
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Layout table for investigator information
Principal Investigator: Woojin Chong, MD Icahn School of Medicine at Mount Sinai
Tracking Information
First Submitted Date  ICMJE May 2, 2019
First Posted Date  ICMJE May 3, 2019
Last Update Posted Date April 28, 2020
Estimated Study Start Date  ICMJE February 2020
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2019) 		Void trial failure rates [ Time Frame: Day of surgery ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Number of participants with Postoperative urinary retention (POUR) [ Time Frame: 2 weeks and 6 weeks post surgery ]
    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.
  • Time to discharge [ Time Frame: On the day of surgery ]
    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.
  • Number of participants with Urinary tract infection [ Time Frame: Within 6 weeks after surgery ]
    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.
  • Incontinence Severity Index (ISI) [ Time Frame: 2 weeks and 6 weeks post surgery ]
    ISI total scored from 0-12, with higher score indicating more severity of symptoms.
  • Urogenital Distress Inventory short form (UDI-6) [ Time Frame: 2 weeks and 6 weeks post surgery ]
    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.
  • Patient Global Impression of Improvement (PGI-I) [ Time Frame: 2 weeks and 6 weeks post surgery ]
    PGI-I is scored on a 7 likert score, with total score from 1 to 7, with higher score indicating worse outcome
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • Number of participants with Postoperative urinary retention (POUR) [ Time Frame: 2 weeks and 6 weeks post surgery ]
    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.
  • Time to discharge [ Time Frame: On the day of surgery ]
    Time to discharge will be determined by calculating the time between arrival to the PACU and the time of discharge using documentation from EPIC.
  • Number of participants with Urinary tract infection [ Time Frame: Within 6 weeks after surgery ]
    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.
  • Incontinence Severity Index (ISI) [ Time Frame: 2 weeks and 6 weeks post surgery ]
    ISI total scored from 0-12, with higher score indicating more severity of symptoms.
  • Urogenital Distress Inventory short form (UDI-6) [ Time Frame: 2 weeks and 6 weeks post surgery ]
    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.
  • Patient Global Impression of Improvement (PGI-I) [ Time Frame: 2 weeks and 6 weeks post surgery ]
    PGI-I is scored on a 7 likert score, with total score from 1 to 7, with higher score indicating worse outcome
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Void Trials After Two Voiding Trials (TVT)
Official Title  ICMJE Comparison of Postoperative Voiding Dysfunction in Two Voiding Trials After Retropubic Midurethral Slings: a Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Postoperative Voiding Dysfunction
  • Postoperative Urinary Retention
Intervention  ICMJE Procedure: Bladder Scanner
PVR will be measured by using a bladder scanner.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Bladder Scanner
  • 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.

    Intervention: Procedure: Bladder Scanner
Publications *
  • Rosseland LA, Stubhaug A, Breivik H. Detecting postoperative urinary retention with an ultrasound scanner. Acta Anaesthesiol Scand. 2002 Mar;46(3):279-82.
  • 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.
  • 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. Review.
  • 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.
  • 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.
  • Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3:S3-9.
  • 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 24, 2020) 		0
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2019) 		116
Estimated Study Completion Date  ICMJE May 30, 2022
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03937531
Other Study ID Numbers  ICMJE GCO 19-0816
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Woojin Chong-Kaufman, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Woojin Chong, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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