Stress Urinary IncontinenceNCT02101489
Precise Transvaginal Tape Placement Trial
A study testing Foley Catheter in people with Stress Urinary Incontinence and Urinary Incontinence, run by Loyola University at 1 site in United States.
Trial summary
This purpose of this study is to study is to see if intra-operative urethral length measurement with the Foley catheter will improve the placement of a synthetic sling in the mid-urethra. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Urinary Incontinence
- What is being tested?
- Foley Catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Nov 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates for TVT
- >=18 years of age to participate
Who cannot join
- Inability to give informed consent
- Previous SUI(stress urinary incontinence) treatment including TVT, Burch or urethral bulking agents
- Previous bladder, urethral malignancies or vaginal/pelvic radiation treatment.
- Pregnant women cannot participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Health System
Maywood, Illinois, 60153
About this study
This purpose of this study is to study is to see if intra-operative urethral length measurement with the Foley catheter will improve the placement of a synthetic sling in the mid-urethra.
Read the detailed description
This study will assess the effect of intraoperative measurement of the urethral length with the Foley catheter in optimization of sling placement in the mid female urethra. Of note, the Foley catheter is well-tolerated, placed routinely during surgery to drain the bladder and has no complications associated with it. Women who have chosen to undergo trans-vaginal tape sling (TVT) for stress urinary incontinence will be asked to enroll in this randomized trial by the study team during their clinic visit. Randomization will be performed by the FPMRS study nurse coordinator after a woman has given her informed consent and meets the study criteria. Twenty women will be randomized to undergo measurement of the urethral length by marking the Foley catheter at the urethral meatus when it is placed at the start of the surgical case. When the catheter is removed, the length from the end of the Foley balloon to the marking at the urethra will be measured as urethral length, the mid urethral point will then be determined by dividing the urethral length be two where the incision of sling placement will be made and twenty women will have our usual pre-operative assessment (which does not include intraoperative measurement of the urethral length with the Foley catheter) for the treatment of symptomatic stress urinary incontinence All women participating in the study will receive an intra-operative 3-D trans-vaginal ultrasound (BK Flex Focus ultrasound with the 8838 transvaginal probe). The image will be stored and reviewed for; urethral length, urethral sphincter complex length and width. All women in the study will have an ultrasound at the end of their surgical procedure and a follow-up ultrasound at 2 weeks post operatively to assess for sling migration. Of note, transvaginal ultrasound is well-tolerated and has no complications associated with it. All ultrasound measurements will be done by a four qualified surgeons, Dr. Elizabeth Mueller Dr. Ahmed Akl, Dr. Tanaka Dune, and Dr. Susanne Taege who have been trained on ultrasound measurements. In addition, women will complete questionnaires assessing their pelvic floor symptoms pre-operatively and at 2 week following surgery. Instruments used will be the Pelvic Floor Disorders Inventory (PFDI), Medical Epidemiologic and Social Aging (MESA) and the Patient Global Impression of Improvement (PGII) [11, 12].
- Conditions
- Stress Urinary Incontinence, Urinary Incontinence
- Being tested
- Foley Catheter
- Keywords
- TVT, Stress urinary incontinence
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley CatheterOther
20 with intraoperative Foley catheter measurement of the urethral length and 20 without
| Study group | Role | What they receive |
|---|---|---|
| Intraop Foley catheter measurement | Active comparator | 20 women will have intraoperative Foley catheter measurement of the urethral length Receives: Other: Foley Catheter |
| Without intraop Foley cath measurement | No intervention | 20 women without intraoperative Foley catheter measurement of the urethral length |
What is being measured
The primary outcome is the main question the study is designed to answer.
If using a Foley catheter is a reliable way to measure the urethral length before placing the tension free vaginal tape in the mid-urethra.
measurement of the urethral length by marking the Foley catheter at the urethral meatus when it is placed at the start of the surgical case. When the catheter is removed, the length from the end of the Foley balloon to the marking at the urethra will be measured as urethral length, the mid urethral point will then be determined by dividing the urethral length be two where the incision of sling placement will be made.
Measured: 2 weeks
Secondary outcomes (3)
Comparing urethral length measurement with the Foley catheter and 3D ultrasound.
All women in the study will have an ultrasound at the end of their surgical procedure and a follow-up ultrasound at 2 weeks post operatively to assess for sling migration.
Measured: 2 weeks
Location change of mid-urethral slings from the time of surgery to 2 weeks after surgery.
We will then compare the mid-point location of the midurethral sling between the group that received an intra-op Foley catheter measurement to the group that didn't receive the Foley catheter.
Measured: 2 weeks
Stratify the data based on patient race, BMI, prolapse and age
Stratify the data based on patient race, BMI, prolapse and age
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 posted2 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Mueller, Loyola University
- Investigators
- Elizabeth R Mueller, M.D., Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101489
- Sponsor's protocol ID
- 206041
- Status last verified
- Feb 2017
- First submitted
- 19 Mar 2014
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Aigmueller T, Trutnovsky G, Tamussino K, Kargl J, Wittmann A, Surtov M, Kern P, Frudinger A, Riss P, Bjelic-Radisic V. Ten-year follow-up after the tension-free vaginal tape procedure. Am J Obstet Gynecol. 2011 Nov;205(5):496.e1-5. doi: 10.1016/j.ajog.2011.07.010. Epub 2011 Jul 20.
PubMed 21944223Olsson I, Abrahamsson AK, Kroon UB. Long-term efficacy of the tension-free vaginal tape procedure for the treatment of urinary incontinence: a retrospective follow-up 11.5 years post-operatively. Int Urogynecol J. 2010 Jun;21(6):679-83. doi: 10.1007/s00192-009-1083-7. Epub 2010 Jan 13.
PubMed 20069417Nilsson CG, Palva K, Rezapour M, Falconer C. Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1043-7. doi: 10.1007/s00192-008-0666-z. Epub 2008 Jun 6.
PubMed 18535753Nilsson CG, Palva K, Aarnio R, Morcos E, Falconer C. Seventeen years' follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence. Int Urogynecol J. 2013 Aug;24(8):1265-9. doi: 10.1007/s00192-013-2090-2. Epub 2013 Apr 6.
PubMed 23563892Bjelic-Radisic V, Dorfer M, Greimel E, Frudinger A, Tamussino K, Winter R. Quality of life and continence 1 year after the tension-free vaginal tape operation. Am J Obstet Gynecol. 2006 Dec;195(6):1784-8. doi: 10.1016/j.ajog.2006.07.014.
PubMed 17132481Kociszewski J, Rautenberg O, Perucchini D, Eberhard J, Geissbuhler V, Hilgers R, Viereck V. Tape functionality: sonographic tape characteristics and outcome after TVT incontinence surgery. Neurourol Urodyn. 2008;27(6):485-90. doi: 10.1002/nau.20556.
PubMed 18288705Rahn DD, Marinis SI, Schaffer JI, Corton MM. Anatomical path of the tension-free vaginal tape: reassessing current teachings. Am J Obstet Gynecol. 2006 Dec;195(6):1809-13. doi: 10.1016/j.ajog.2006.07.009.
PubMed 17132484McGuire EJ, Lytton B. Pubovaginal sling procedure for stress incontinence. 1978. J Urol. 2002 Feb;167(2 Pt 2):1120-3; discussion 1124. doi: 10.1016/s0022-5347(02)80355-x. No abstract available.
PubMed 11905885Barber MD, Chen Z, Lukacz E, Markland A, Wai C, Brubaker L, Nygaard I, Weidner A, Janz NK, Spino C. Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Neurourol Urodyn. 2011 Apr;30(4):541-6. doi: 10.1002/nau.20934. Epub 2011 Feb 22.
PubMed 21344495
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precise Transvaginal Tape Placement Trial
- ClinicalTrials.gov ID
- NCT02101489
- Acronym / sponsor ID
- 206041
- Conditions
- Stress Urinary Incontinence, Urinary Incontinence
- Keywords
- TVT, Stress urinary incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 2 Apr 2014 (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.
This purpose of this study is to study is to see if intra-operative urethral length measurement with the Foley catheter will improve the placement of a synthetic sling in the mid-urethra.
Detailed description
This study will assess the effect of intraoperative measurement of the urethral length with the Foley catheter in optimization of sling placement in the mid female urethra. Of note, the Foley catheter is well-tolerated, placed routinely during surgery to drain the bladder and has no complications associated with it. Women who have chosen to undergo trans-vaginal tape sling (TVT) for stress urinary incontinence will be asked to enroll in this randomized trial by the study team during their clinic visit. Randomization will be performed by the FPMRS study nurse coordinator after a woman has given her informed consent and meets the study criteria. Twenty women will be randomized to undergo measurement of the urethral length by marking the Foley catheter at the urethral meatus when it is placed at the start of the surgical case. When the catheter is removed, the length from the end of the Foley balloon to the marking at the urethra will be measured as urethral length, the mid urethral point will then be determined by dividing the urethral length be two where the incision of sling placement will be made and twenty women will have our usual pre-operative assessment (which does not include intraoperative measurement of the urethral length with the Foley catheter) for the treatment of symptomatic stress urinary incontinence All women participating in the study will receive an intra-operative 3-D trans-vaginal ultrasound (BK Flex Focus ultrasound with the 8838 transvaginal probe). The image will be stored and reviewed for; urethral length, urethral sphincter complex length and width. All women in the study will have an ultrasound at the end of their surgical procedure and a follow-up ultrasound at 2 weeks post operatively to assess for sling migration. Of note, transvaginal ultrasound is well-tolerated and has no complications associated with it. All ultrasound measurements will be done by a four qualified surgeons, Dr. Elizabeth Mueller Dr. Ahmed Akl, Dr. Tanaka Dune, and Dr. Susanne Taege who have been trained on ultrasound measurements. In addition, women will complete questionnaires assessing their pelvic floor symptoms pre-operatively and at 2 week following surgery. Instruments used will be the Pelvic Floor Disorders Inventory (PFDI), Medical Epidemiologic and Social Aging (MESA) and the Patient Global Impression of Improvement (PGII) [11, 12].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraop Foley catheter measurement | Active comparator | Other: Foley Catheter20 women will have intraoperative Foley catheter measurement of the urethral length |
| Without intraop Foley cath measurement | No intervention | –20 women without intraoperative Foley catheter measurement of the urethral length |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Candidates for TVT
- >=18 years of age to participate
Key exclusion criteria (4 listed)
- Inability to give informed consent
- Previous SUI(stress urinary incontinence) treatment including TVT, Burch or urethral bulking agents
- Previous bladder, urethral malignancies or vaginal/pelvic radiation treatment.
- Pregnant women cannot participate
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 |
|---|---|---|
| Foley Catheter20 with intraoperative Foley catheter measurement of the urethral length and 20 without | Other | Intraop Foley catheter measurement |
Primary outcome
If using a Foley catheter is a reliable way to measure the urethral length before placing the tension free vaginal tape in the mid-urethra.
Time frame: 2 weeks
measurement of the urethral length by marking the Foley catheter at the urethral meatus when it is placed at the start of the surgical case. When the catheter is removed, the length from the end of the Foley balloon to the marking at the urethra will be measured as urethral length, the mid urethral point will then be determined by dividing the urethral length be two where the incision of sling placement will be made.
3 secondary outcomes
Comparing urethral length measurement with the Foley catheter and 3D ultrasound.
Time frame: 2 weeks
Location change of mid-urethral slings from the time of surgery to 2 weeks after surgery.
Time frame: 2 weeks
Stratify the data based on patient race, BMI, prolapse and age
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 1 Mar 2017.
- Background: PubMed 21944223Aigmueller T, Trutnovsky G, Tamussino K, Kargl J, Wittmann A, Surtov M, Kern P, Frudinger A, Riss P, Bjelic-Radisic V. Ten-year follow-up after the tension-free vaginal tape procedure. Am J Obstet Gynecol. 2011 Nov;205(5):496.e1-5. doi: 10.1016/j.ajog.2011.07.010. Epub 2011 Jul 20.
- Background: PubMed 20069417Olsson I, Abrahamsson AK, Kroon UB. Long-term efficacy of the tension-free vaginal tape procedure for the treatment of urinary incontinence: a retrospective follow-up 11.5 years post-operatively. Int Urogynecol J. 2010 Jun;21(6):679-83. doi: 10.1007/s00192-009-1083-7. Epub 2010 Jan 13.
- Background: PubMed 18535753Nilsson CG, Palva K, Rezapour M, Falconer C. Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1043-7. doi: 10.1007/s00192-008-0666-z. Epub 2008 Jun 6.
- Background: PubMed 23563892Nilsson CG, Palva K, Aarnio R, Morcos E, Falconer C. Seventeen years' follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence. Int Urogynecol J. 2013 Aug;24(8):1265-9. doi: 10.1007/s00192-013-2090-2. Epub 2013 Apr 6.
- Background: PubMed 17132481Bjelic-Radisic V, Dorfer M, Greimel E, Frudinger A, Tamussino K, Winter R. Quality of life and continence 1 year after the tension-free vaginal tape operation. Am J Obstet Gynecol. 2006 Dec;195(6):1784-8. doi: 10.1016/j.ajog.2006.07.014.
- Background: PubMed 18288705Kociszewski J, Rautenberg O, Perucchini D, Eberhard J, Geissbuhler V, Hilgers R, Viereck V. Tape functionality: sonographic tape characteristics and outcome after TVT incontinence surgery. Neurourol Urodyn. 2008;27(6):485-90. doi: 10.1002/nau.20556.
- Background: PubMed 17132484Rahn DD, Marinis SI, Schaffer JI, Corton MM. Anatomical path of the tension-free vaginal tape: reassessing current teachings. Am J Obstet Gynecol. 2006 Dec;195(6):1809-13. doi: 10.1016/j.ajog.2006.07.009.
- Background: PubMed 11905885McGuire EJ, Lytton B. Pubovaginal sling procedure for stress incontinence. 1978. J Urol. 2002 Feb;167(2 Pt 2):1120-3; discussion 1124. doi: 10.1016/s0022-5347(02)80355-x. No abstract available.
- Background: PubMed 21344495Barber MD, Chen Z, Lukacz E, Markland A, Wai C, Brubaker L, Nygaard I, Weidner A, Janz NK, Spino C. Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Neurourol Urodyn. 2011 Apr;30(4):541-6. doi: 10.1002/nau.20934. Epub 2011 Feb 22.
- Individual participant dataSharing planned: Undecided
Related trials for Stress Urinary Incontinence
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Recruiting
Comparing the Effect of Two Types of Pelvic Floor Muscle Stimulation Devices to Improve Symptoms of Urinary Incontinence in Women.
Urinary Incontinence, Mixed Urinary Incontinence
Active, not recruiting
A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
Stress Urinary Incontinence (SUI)
Recruiting
Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy
Urinary Incontinence , Stress, Prostatectomy
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.
Elizabeth R Mueller, M.D. principal investigator
Loyola University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foley Catheter in people with Stress Urinary Incontinence and Urinary Incontinence, run by Loyola University 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 4 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 1 Mar 2017. 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?
If using a Foley catheter is a reliable way to measure the urethral length before placing the tension free vaginal tape in the mid-urethra. (time frame: 2 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 NCT02101489, which also lists 9 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 1 Mar 2017.