Postoperative Voiding DysfunctionNCT03937531
Void Trials After Two Voiding Trials (TVT)
A study testing Bladder Scanner in people with Postoperative Voiding Dysfunction and Postoperative Urinary Retention, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Voiding Dysfunction, Postoperative Urinary Retention
- What is being tested?
- Bladder Scanner
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2020to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mount Sinai West
New York, New York, 10019
Mount Sinai Medical Center
New York, New York, 10029
About this study
Official title: Comparison of Postoperative Voiding Dysfunction in Two Voiding Trials After Retropubic Midurethral Slings: a Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Bladder Scanner
- Keywords
- Postoperative voiding dysfunction, Postoperative void trial, Retrograde fill void trial, Spontaneous void trial, Midurethral sling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder ScannerProcedure or surgery
PVR will be measured by using a bladder scanner.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Bladder Scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of surgery
Secondary outcomes (6)
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.
Measured: 2 weeks and 6 weeks post surgery
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.
Measured: On the day of surgery
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.
Measured: Within 6 weeks after surgery
Incontinence Severity Index (ISI)
ISI total scored from 0-12, with higher score indicating more severity of symptoms.
Measured: 2 weeks and 6 weeks post surgery
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.
Measured: 2 weeks and 6 weeks post surgery
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
Measured: 2 weeks and 6 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study startFeb 2020 (estimated)
- Primary completion30 May 2021 (estimated)
- Study completion30 May 2022 (estimated)
Why it stopped: PI Left the Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Postoperative Voiding DysfunctionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woojin Chong-Kaufman, Icahn School of Medicine at Mount Sinai
- Investigators
- Woojin Chong, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937531
- Sponsor's protocol ID
- GCO 19-0816
- Status last verified
- Apr 2020
- First submitted
- 2 May 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11939918Partoll 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.
PubMed 12066111Tunitsky-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.
PubMed 25434837Trautner 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.
PubMed 15111369Barron 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.
PubMed 16583182Geller 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.
PubMed 25210477Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S3-9.
PubMed 16985863Barber 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.
PubMed 18310363Dieter 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.
PubMed 22543772Yokoe 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.
PubMed 25026611Dindo 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.
PubMed 15273542
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Voiding Dysfunction in Two Voiding Trials After Retropubic Midurethral Slings: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03937531
- Acronym / sponsor ID
- GCO 19-0816
- Keywords
- Postoperative voiding dysfunction, Postoperative void trial, Retrograde fill void trial, Spontaneous void trial, Midurethral sling
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI Left the Institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Feb 2020 (estimated)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Retrograde-fill void trial (RVT) | Experimental | Procedure: Bladder ScannerSubjects 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. |
| Spontaneous void trial (SVT) | Active comparator | Procedure: Bladder ScannerSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bladder ScannerPVR will be measured by using a bladder scanner. | Procedure or surgery | Retrograde-fill void trial (RVT), Spontaneous void trial (SVT) |
Primary outcome
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.
6 secondary outcomes
Number of participants with Postoperative urinary retention (POUR)
Time frame: 2 weeks and 6 weeks post surgery
Time to discharge
Time frame: On the day of surgery
Number of participants with Urinary tract infection
Time frame: Within 6 weeks after surgery
Incontinence Severity Index (ISI)
Time frame: 2 weeks and 6 weeks post surgery
Urogenital Distress Inventory short form (UDI-6)
Time frame: 2 weeks and 6 weeks post surgery
Patient Global Impression of Improvement (PGI-I)
Time frame: 2 weeks and 6 weeks post surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Background: PubMed 11939918Rosseland 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.
- Background: PubMed 12066111Partoll 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.
- Background: PubMed 25434837Tunitsky-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.
- Background: PubMed 15111369Trautner 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.
- Background: PubMed 16583182Barron 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.
- Background: PubMed 25210477Geller 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.
- Background: PubMed 16985863Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S3-9.
- Background: PubMed 18310363Barber 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.
- Background: PubMed 22543772Dieter 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.
- Background: PubMed 25026611Yokoe 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.
- Background: PubMed 15273542Dindo 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.
- 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.e6Link provided by the sponsor.
- EL-Hefnawy A, Wadie B, Abed A, Nabeeh A. Post-operative complications of midurethral slings: is it possible to use Clavien's classification? \[ICS Abstract 848\].Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woojin Chong, MD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder Scanner in people with Postoperative Voiding Dysfunction and Postoperative Urinary Retention, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Void trial failure rates (time frame: Day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03937531, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.