Stress Urinary IncontinenceNCT02400034
Comparing Voiding Trials After Midurethral Sling for Stress Incontinence
A study testing Voiding trial in people with Stress Urinary Incontinence and Urethral Hypermobility, run by Northwell Health at 1 site in United States.
Trial summary
Urinary incontinence is a prevalent health and quality of life concern affecting almost half of women over the age of 20. Urinary retention (abnormal holding of urine) is a concern of many surgeons who perform midurethral sling 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
- Stress Urinary Incontinence, Urethral Hypermobility, Cystocele
- What is being tested?
- Voiding trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jun 2016
- 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
- Postoperative patients after placement of midurethral sling (retropubic sling or transobturator) with or without anterior or posterior colporrhaphy.
- Ability to provide informed consent and complete all study requirements
Who cannot join
- Patients who underwent a surgery that requires long term catheterization (i.e fistula repair or urethral diverticulum)
- Patients who sustained a cystotomy during surgery as our divisional protocol is to send these patients home with a Foley catheter for 5-14 days without a voiding trial
- Patients who had an apical repair for pelvic organ prolapse (Uterosacral vaginal vault suspension, Abdominal sacral colpopexy, sacrospinous ligament fixation)
Trial locations and contacts
1 site in 1 country.
United States1 site
Urogynecology, Female Pelvic Medicine and Reconstructive Surgery
Great Neck, New York, 11021
About this study
Official title: A Randomized Controlled Trial Comparing Force of Stream to Traditional Retrograde Fill Voiding Trial After Midurethral Sling With or Without Vaginal Prolapse Surgery
Urinary incontinence is a prevalent health and quality of life concern affecting almost half of women over the age of 20. Urinary retention (abnormal holding of urine) is a concern of many surgeons who perform midurethral sling surgery. All patients after outpatient midurethral sling or vaginal prolpase surgery must complete a voiding trial if they are to be discharged without a catheter. The purpose of this study is to compare two different types of postoperative voiding trials to determine which leads to less post-operative issues, such as urinary retention requiring catheterization. You are being asked to participate because you are having midurethral sling surgery, either with or without vaginal prolapse repair.
Read the detailed description
Urinary incontinence is a prevalent health and quality of life concern affecting an estimated 49.6% of women over the age of 20 years in the USA. (1) Of these, 49.8% describe pure stress urinary incontinence (SUI) and 34.3% report mixed stress and urgency urinary incontinence. (1)
Midurethral sling (MUS) surgery is used to treat women with SUI, but accepted protocols for voiding trials after midurethral sling placement do not exist. Primarily, many surgeons measure postvoid residual (PVR) urine volume. This is done by retrograde filling of the bladder with a predetermined amount of normal saline or water. The catheter is then removed and the patient is permitted to void into a collection basin. The amount in the basin is subtracted from the filled amount. The need for catheterization is generally based on arbitrarily determined ratios of voided urine to PVR or postoperative.
The acceptable amount voided during catheterization varies among practitioners. In a study by Kleeman et al, the patient was required to void >50% of volume filled during retrograde fill for discharge from hospital without an indwelling Foley catheter (2). Pulvino et al, required that the patient void > 2/3 the amount of the volume placed during retrograde fill (3). The force of stream trial (FAST) does not prioritize amount voided, but rather the patient's subjective force of stream. The bladder is retrograde filled with 300cc normal saline or water and the patient is instructed to void.. Using FAST, a patient uses a VAS scale to quantify her force of stream. If she states that her Force of Stream (FOS) is >50% stronger than prior to surgery, independent of the amount voided, she is discharged without a catheter. If the FOS is <50% a PVR via bladder scan is performed. If her PVR is <500cc the patient was discharged home without a catheter in place. If the PVR, via bladder scan was > 500cc she was discharged with a catheter. Ingber et. Al. showed the FAST method was a safe method for predicting postoperative voiding dysfunction and/or urinary retention. No patients presented to the office or emergency room for voiding dysfunction or urinary retention (4).
Urinary retention is a concern of many surgeons who perform midurethral sling surgery; 25% of urologists routinely discharge patients home with a catheter and 31% admit patients overnight or for 23 hour observation, with 42% doing so for the primary purpose of facilitating the voiding trial. (5)
Published catheterization rates for these protocols can approach 39%. (6,7) Temporary catheterization does not pose a significant medical risk, but it is perceived as an inconvenience and source of discomfort for many patients. Proper care of an indwelling foley catheter requires extra teaching from nursing and/or house staff.
No randomized control trials (RCT) have been performed comparing the FAST method to the traditional retrograde voiding trial. In our practice we assess postoperative voiding function using the retrograde fill with 300cc saline or water. We also require a 2/3 quantity voided for discontinuation of catheter.
All patients after outpatient midurethral sling or vaginal prolpase surgery must complete a voiding trial if they are to be discharged without a catheter. This is standard of care and followed in our practice. We would like to compare both postoperative voiding trials in patients who have undergone surgical repair concomitant midurethral sling with or without anterior colporrhaphy. We will include those patients who also had an anterior colporrhaphy at time of sling placement as this procedure is commonly performed at the time of sling placement for stablization of MUS. We will assess the number of emergent or unexpected visits for voiding dysfunction. An unexpected visit to the office will be defined as any visit outside of the patient's prior scheduled postoperative visits.
- Being tested
- Voiding trial
- Keywords
- midurethral sling, Voiding trial, stress urinary incontinence
- Medical subject headings
- Urinary Incontinence, Stress, Cystocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voiding trialOther
Also called voiding
1 of 2 tests to assess bladder function after midurethral sling surgery with and without anterior or posterior colporrhaphy
| Study group | Role | What they receive |
|---|---|---|
| FAST voiding trial method | Active comparator | 1) Bladder drained with indwelling foley catheter, then retrograde filled with 300cc sterile water. 2) catheter is removed; 3) Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). 4) The patient will subjectively quantify their FOS via VAS scale. 5) If VAS scale >50 (=50%) the catheter will remain out, patient is discharged home without measuring a PVR 6) If VAS scale is from 0-49 (= 0-49%) a PVR will be checked via bladder scan. If PVR is <500 the patient will be discharged WITHOUT a catheter; If PVR is >500 the patient will be discharged WITH a catheter. If she is discharged with an indwelling foley catheter, she will have an in-office retrograde voiding trial in 2-5 days Receives: Other: Voiding trial |
| Retrograde fill voiding trial method | Active comparator | 1) Bladder drained with indwelling foley catheter, then retrograde filled with 300cc sterile water. 2) catheter is removed; 3) Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). 4) The patient will subjectively quantify their FOS via VAS scale (however this information will only be used for research purposes). 5) If she voids >/= 2/3 (200cc) the catheter will remain out as she will have passed her voiding trial. If she voids < 200cc she will be discharged home with a catheter and instructed to follow-up in 2-5 days for an in-office retrograde voiding trial in 2-5 days. Receives: Other: Voiding trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of emergency room visits or unexpected visits to the office within 6 weeks postoperatively for voiding dysfunction or suspected infection
Any additional visit outside the patient's scheduled postoperative visits to the emergency room, urgent care facility or doctor's office will be recorded for up to 6 six weeks postoperatively
Measured: 6 weeks
Secondary outcomes (4)
Number of patients sent home with a catheter
the number of patients in each arm who are sent home with a catheter will be recorded
Measured: 6 weeks
Number of patients with reported UTI
Measured: 6 weeks
Time to discharge from hospital
Time upon arrival to Post Anesthesia Care Unit to discharge to home will be calculated for each arm
Measured: 6 weeks
Patient satisfaction with postoperative bladder function
American Urological Association Symptom Score (AUASS); Urinary Distress Inventory (UDI-6)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionJun 2016
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 Stress Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harvey Winkler, Northwell Health
- Investigators
- Harvey A Winkler, MD, Principal investigator, North Shore LIJ Divsion of Female Pelvic Medicine and Reconstructive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400034
- Sponsor's protocol ID
- 14-667
- Status last verified
- Oct 2016
- First submitted
- 23 Mar 2015
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stav K, Dwyer PL, Rosamilia A, Schierlitz L, Lim YN, Chao F, De Souza A, Thomas E, Murray C, Conway C, Lee J. Repeat synthetic mid urethral sling procedure for women with recurrent stress urinary incontinence. J Urol. 2010 Jan;183(1):241-6. doi: 10.1016/j.juro.2009.08.111.
PubMed 19913831Kleeman S, Goldwasser S, Vassallo B, Karram M. Predicting postoperative voiding efficiency after operation for incontinence and prolapse. Am J Obstet Gynecol. 2002 Jul;187(1):49-52. doi: 10.1067/mob.2002.124841.
PubMed 12114887Pulvino JQ, Duecy EE, Buchsbaum GM, Flynn MK. Comparison of 2 techniques to predict voiding efficiency after inpatient urogynecologic surgery. J Urol. 2010 Oct;184(4):1408-12. doi: 10.1016/j.juro.2010.05.096. Epub 2010 Aug 19.
PubMed 20727543Ingber MS, Vasavada SP, Moore CK, Rackley RR, Firoozi F, Goldman HB. Force of stream after sling therapy: safety and efficacy of rapid discharge care pathway based on subjective patient report. J Urol. 2011 Mar;185(3):993-7. doi: 10.1016/j.juro.2010.10.050. Epub 2011 Jan 19.
PubMed 21247598Barron 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 16583182Foster RT Sr, Borawski KM, South MM, Weidner AC, Webster GD, Amundsen CL. A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing after transvaginal surgery. Am J Obstet Gynecol. 2007 Dec;197(6):627.e1-4. doi: 10.1016/j.ajog.2007.08.017.
PubMed 18060956Peleg AY, Hooper DC. Hospital-acquired infections due to gram-negative bacteria. N Engl J Med. 2010 May 13;362(19):1804-13. doi: 10.1056/NEJMra0904124. No abstract available.
PubMed 20463340El-Barky E, El-Shazly A, El-Wahab OA, Kehinde EO, Al-Hunayan A, Al-Awadi KA. Tension free vaginal tape versus Burch colposuspension for treatment of female stress urinary incontinence. Int Urol Nephrol. 2005;37(2):277-81. doi: 10.1007/s11255-004-6101-6.
PubMed 16142556Barber 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 18310363Ward KL, Hilton P; UK and Ireland TVT Trial Group. Tension-free vaginal tape versus colposuspension for primary urodynamic stress incontinence: 5-year follow up. BJOG. 2008 Jan;115(2):226-33. doi: 10.1111/j.1471-0528.2007.01548.x. Epub 2007 Oct 25.
PubMed 17970791Liapis A, Bakas P, Creatsas G. Long-term efficacy of tension-free vaginal tape in the management of stress urinary incontinence in women: efficacy at 5- and 7-year follow-up. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Nov;19(11):1509-12. doi: 10.1007/s00192-008-0664-1. Epub 2008 Jun 10.
PubMed 18542836
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Force of Stream to Traditional Retrograde Fill Voiding Trial After Midurethral Sling With or Without Vaginal Prolapse Surgery
- ClinicalTrials.gov ID
- NCT02400034
- Acronym / sponsor ID
- 14-667
- Keywords
- midurethral sling, Voiding trial, stress urinary incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Mar 2015 (estimated)
- 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.
Urinary incontinence is a prevalent health and quality of life concern affecting almost half of women over the age of 20. Urinary retention (abnormal holding of urine) is a concern of many surgeons who perform midurethral sling surgery. All patients after outpatient midurethral sling or vaginal prolpase surgery must complete a voiding trial if they are to be discharged without a catheter. The purpose of this study is to compare two different types of postoperative voiding trials to determine which leads to less post-operative issues, such as urinary retention requiring catheterization. You are being asked to participate because you are having midurethral sling surgery, either with or without vaginal prolapse repair.
Detailed description
Urinary incontinence is a prevalent health and quality of life concern affecting an estimated 49.6% of women over the age of 20 years in the USA. (1) Of these, 49.8% describe pure stress urinary incontinence (SUI) and 34.3% report mixed stress and urgency urinary incontinence. (1)
Midurethral sling (MUS) surgery is used to treat women with SUI, but accepted protocols for voiding trials after midurethral sling placement do not exist. Primarily, many surgeons measure postvoid residual (PVR) urine volume. This is done by retrograde filling of the bladder with a predetermined amount of normal saline or water. The catheter is then removed and the patient is permitted to void into a collection basin. The amount in the basin is subtracted from the filled amount. The need for catheterization is generally based on arbitrarily determined ratios of voided urine to PVR or postoperative.
The acceptable amount voided during catheterization varies among practitioners. In a study by Kleeman et al, the patient was required to void >50% of volume filled during retrograde fill for discharge from hospital without an indwelling Foley catheter (2). Pulvino et al, required that the patient void > 2/3 the amount of the volume placed during retrograde fill (3). The force of stream trial (FAST) does not prioritize amount voided, but rather the patient's subjective force of stream. The bladder is retrograde filled with 300cc normal saline or water and the patient is instructed to void.. Using FAST, a patient uses a VAS scale to quantify her force of stream. If she states that her Force of Stream (FOS) is >50% stronger than prior to surgery, independent of the amount voided, she is discharged without a catheter. If the FOS is <50% a PVR via bladder scan is performed. If her PVR is <500cc the patient was discharged home without a catheter in place. If the PVR, via bladder scan was > 500cc she was discharged with a catheter. Ingber et. Al. showed the FAST method was a safe method for predicting postoperative voiding dysfunction and/or urinary retention. No patients presented to the office or emergency room for voiding dysfunction or urinary retention (4).
Urinary retention is a concern of many surgeons who perform midurethral sling surgery; 25% of urologists routinely discharge patients home with a catheter and 31% admit patients overnight or for 23 hour observation, with 42% doing so for the primary purpose of facilitating the voiding trial. (5)
Published catheterization rates for these protocols can approach 39%. (6,7) Temporary catheterization does not pose a significant medical risk, but it is perceived as an inconvenience and source of discomfort for many patients. Proper care of an indwelling foley catheter requires extra teaching from nursing and/or house staff.
No randomized control trials (RCT) have been performed comparing the FAST method to the traditional retrograde voiding trial. In our practice we assess postoperative voiding function using the retrograde fill with 300cc saline or water. We also require a 2/3 quantity voided for discontinuation of catheter.
All patients after outpatient midurethral sling or vaginal prolpase surgery must complete a voiding trial if they are to be discharged without a catheter. This is standard of care and followed in our practice. We would like to compare both postoperative voiding trials in patients who have undergone surgical repair concomitant midurethral sling with or without anterior colporrhaphy. We will include those patients who also had an anterior colporrhaphy at time of sling placement as this procedure is commonly performed at the time of sling placement for stablization of MUS. We will assess the number of emergent or unexpected visits for voiding dysfunction. An unexpected visit to the office will be defined as any visit outside of the patient's prior scheduled postoperative visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAST voiding trial method | Active comparator | Other: Voiding trial1) Bladder drained with indwelling foley catheter, then retrograde filled with 300cc sterile water. 2) catheter is removed; 3) Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). 4) The patient will subjectively quantify their FOS via VAS scale. 5) If VAS scale >50 (=50%) the catheter will remain out, patient is discharged home without measuring a PVR 6) If VAS scale is from 0-49 (= 0-49%) a PVR will be checked via bladder scan. If PVR is <500 the patient will be discharged WITHOUT a catheter; If PVR is >500 the patient will be discharged WITH a catheter. If she is discharged with an indwelling foley catheter, she will have an in-office retrograde voiding trial in 2-5 days |
| Retrograde fill voiding trial method | Active comparator | Other: Voiding trial1) Bladder drained with indwelling foley catheter, then retrograde filled with 300cc sterile water. 2) catheter is removed; 3) Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). 4) The patient will subjectively quantify their FOS via VAS scale (however this information will only be used for research purposes). 5) If she voids >/= 2/3 (200cc) the catheter will remain out as she will have passed her voiding trial. If she voids < 200cc she will be discharged home with a catheter and instructed to follow-up in 2-5 days for an in-office retrograde voiding trial in 2-5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postoperative patients after placement of midurethral sling (retropubic sling or transobturator) with or without anterior or posterior colporrhaphy.
- Ability to provide informed consent and complete all study requirements
Key exclusion criteria (3 listed)
- Patients who underwent a surgery that requires long term catheterization (i.e fistula repair or urethral diverticulum)
- Patients who sustained a cystotomy during surgery as our divisional protocol is to send these patients home with a Foley catheter for 5-14 days without a voiding trial
- Patients who had an apical repair for pelvic organ prolapse (Uterosacral vaginal vault suspension, Abdominal sacral colpopexy, sacrospinous ligament fixation)
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 |
|---|---|---|
| Voiding trialAlso: voiding1 of 2 tests to assess bladder function after midurethral sling surgery with and without anterior or posterior colporrhaphy | Other | FAST voiding trial method, Retrograde fill voiding trial method |
Primary outcome
Rate of emergency room visits or unexpected visits to the office within 6 weeks postoperatively for voiding dysfunction or suspected infection
Time frame: 6 weeks
Any additional visit outside the patient's scheduled postoperative visits to the emergency room, urgent care facility or doctor's office will be recorded for up to 6 six weeks postoperatively
4 secondary outcomes
Number of patients sent home with a catheter
Time frame: 6 weeks
Number of patients with reported UTI
Time frame: 6 weeks
Time to discharge from hospital
Time frame: 6 weeks
Patient satisfaction with postoperative bladder function
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Background: PubMed 19913831Stav K, Dwyer PL, Rosamilia A, Schierlitz L, Lim YN, Chao F, De Souza A, Thomas E, Murray C, Conway C, Lee J. Repeat synthetic mid urethral sling procedure for women with recurrent stress urinary incontinence. J Urol. 2010 Jan;183(1):241-6. doi: 10.1016/j.juro.2009.08.111.
- Background: PubMed 12114887Kleeman S, Goldwasser S, Vassallo B, Karram M. Predicting postoperative voiding efficiency after operation for incontinence and prolapse. Am J Obstet Gynecol. 2002 Jul;187(1):49-52. doi: 10.1067/mob.2002.124841.
- Background: PubMed 20727543Pulvino JQ, Duecy EE, Buchsbaum GM, Flynn MK. Comparison of 2 techniques to predict voiding efficiency after inpatient urogynecologic surgery. J Urol. 2010 Oct;184(4):1408-12. doi: 10.1016/j.juro.2010.05.096. Epub 2010 Aug 19.
- Background: PubMed 21247598Ingber MS, Vasavada SP, Moore CK, Rackley RR, Firoozi F, Goldman HB. Force of stream after sling therapy: safety and efficacy of rapid discharge care pathway based on subjective patient report. J Urol. 2011 Mar;185(3):993-7. doi: 10.1016/j.juro.2010.10.050. Epub 2011 Jan 19.
- 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 18060956Foster RT Sr, Borawski KM, South MM, Weidner AC, Webster GD, Amundsen CL. A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing after transvaginal surgery. Am J Obstet Gynecol. 2007 Dec;197(6):627.e1-4. doi: 10.1016/j.ajog.2007.08.017.
- Background: PubMed 20463340Peleg AY, Hooper DC. Hospital-acquired infections due to gram-negative bacteria. N Engl J Med. 2010 May 13;362(19):1804-13. doi: 10.1056/NEJMra0904124. No abstract available.
- Background: PubMed 16142556El-Barky E, El-Shazly A, El-Wahab OA, Kehinde EO, Al-Hunayan A, Al-Awadi KA. Tension free vaginal tape versus Burch colposuspension for treatment of female stress urinary incontinence. Int Urol Nephrol. 2005;37(2):277-81. doi: 10.1007/s11255-004-6101-6.
- 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 17970791Ward KL, Hilton P; UK and Ireland TVT Trial Group. Tension-free vaginal tape versus colposuspension for primary urodynamic stress incontinence: 5-year follow up. BJOG. 2008 Jan;115(2):226-33. doi: 10.1111/j.1471-0528.2007.01548.x. Epub 2007 Oct 25.
- Background: PubMed 18542836Liapis A, Bakas P, Creatsas G. Long-term efficacy of tension-free vaginal tape in the management of stress urinary incontinence in women: efficacy at 5- and 7-year follow-up. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Nov;19(11):1509-12. doi: 10.1007/s00192-008-0664-1. Epub 2008 Jun 10.
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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.
Harvey A Winkler, MD principal investigator
North Shore LIJ Divsion of Female Pelvic Medicine and Reconstructive Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voiding trial in people with Stress Urinary Incontinence and Urethral Hypermobility, run by Northwell Health at 1 site 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 3 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: finished, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of emergency room visits or unexpected visits to the office within 6 weeks postoperatively for voiding dysfunction or suspected infection (time frame: 6 weeks). 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 NCT02400034, 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 21 Oct 2016; AzTrials last refreshed its copy on 31 Oct 2026.