Efficacy/Safety of Midurethral Sling
August 30, 2025 updated by: Chin-Tsung Shen, Mackay Medical College
Evaluation of Efficacy and Safety of Midurethral Slings in Women With Stress Incontinence
The trans-obturator tape (TOT), which exhibits a satisfactory cure rate and a relatively diminished invasiveness, has been increasingly accepted as a surgical treatment of stress urinary incontinence (SUI) patients.
Nevertheless, in contrast to the well-recognized therapeutic benefit of the enhanced resistance to the bladder continence during urine storage, if the voiding function of the bladder adapts to the TOT-enhanced outlet resistance has not been adequately investigated.
This study retrospectively assayed the voiding efficacy of each voiding cycle, to clarify if the thermodynamic efficacy of the bladder was modified in response to the TOT surgery.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
- Procedure: Urodynamic investigations before and after a trans-obturator tape protocol.
- Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
- Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
- Procedure: Urodynamic investigations before and after a mini Arc protocol.
- Procedure: Urodynamic investigations before and after an Solyx sling protocol.
Detailed Description
The urodynamic study included free uroflowmetry, postvoid residual, filling and voiding cystometry, and a urethral pressure profile. The filling cystometry and urethral pressure profile were performed with 37 degrees C normal saline similar to body temperature at an infusion rate of 80 ml/min. All patients received a pre- and a post-operative urodynamic evaluation, in which pre-operative evaluation was conducted 1-4 weeks before TOT procedure, and post-operative evaluation was done at 4-6 weeks follow-up.
Complete multichannel urodynamic studies including free uroflowmetry, filling and voiding cystometry, and urethral pressure profile was performed in each patient. The urodynamic parameters measured were the maximum flow rate (Qmax), voided volume, post-void residual volume (PVR), and detrusor pressure at Qmax (Pdet. Qmax). The filling cystometry and urethral pressure profile were performed with 37 degrees C normal saline at an infusion rate of 80 ml/min. All data were recorded and analyzed using a Medical Measurement Systems (MMS UD-200, Enschede, The Netherlands). All data in this study will be expressed as mean ± SEM. After checking the normality and variance of data, two-way ANOVAs were used to assess the difference in values among testing groups and time points; and post hoc Student-Newman-Keuls tests were used to compare the means of groups when there was a significant difference between groups. Significance was set at p<0.05.
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hui-Hsuan Lau, M.D.
- Phone Number: +886-975-835928
- Email: huihsuan1220@gmail.com
Study Locations
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-
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New Taipei City, Taiwan
- Recruiting
- Department of Obstetrics and Gynecology
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Contact:
- Hui-Hsuan Lau, PhD
- Phone Number: +886 975-835928
- Email: huihsuan1220@gmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Clinical diagnosis of stress urinary incontience
- Have urodynamic investigations before and after operation.
Exclusion Criteria:
- Exclusion criteria will be a history of (1) cardiovascular, (2) neurological, or (3) other medical (such as diabetes or inflammation) problems as well as (4) patients who received a concomitant surgical procedure.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Before TOT
Data obtained before the operation
|
Urodynamic investigations (The urodynamic study included free uroflowmetry, postvoid residual, filling and voiding cystometry, and a urethral pressure profile.
The filling cystometry and urethral pressure profile were performed with 37 degrees C normal saline similar to body temperature at an infusion rate of 80 ml/min.)
|
|
Experimental: After TOT
Data obtained after the operation
|
Urodynamic investigations (The urodynamic study included free uroflowmetry, postvoid residual, filling and voiding cystometry, and a urethral pressure profile.
The filling cystometry and urethral pressure profile were performed with 37 degrees C normal saline similar to body temperature at an infusion rate of 80 ml/min.)
|
|
Experimental: Before TVT-O
Data obtained before the operation.
|
Urodynamic investigations (stated above.)
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Experimental: After TVT-O
Data obtained after the operation.
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Urodynamic investigations (stated above.)
|
|
Experimental: Aged patient (>50 y/o) before TVT-O
Data obtained before the operation.
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Urodynamic investigations (stated above.)
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Experimental: Aged patient (>50 y/o) after TVT-O
Data obtained after the operation.
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Urodynamic investigations (stated above.)
|
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Experimental: Young patients (<50 y/o) before TVT-O
Data obtained before the operation.
|
Urodynamic investigations (stated above.)
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Experimental: Young patients (<50 y/o) after TVT-O
Data obtained after the operation.
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Urodynamic investigations (stated above.)
|
|
Experimental: Menopausal patient before TVT-O
Data obtained before the operation.
|
Urodynamic investigations (stated above.)
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Experimental: Menopausal patient after TVT-O
Data obtained after the operation.
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Urodynamic investigations (stated above.)
|
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Experimental: Pre-menopausal patient before TVT-O
Data obtained before the operation.
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Urodynamic investigations (stated above.)
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Experimental: Pre-menopausal patients after TVT-O
Data obtained after the operation.
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Urodynamic investigations (stated above.)
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|
Experimental: Before i-STOP
Data obtained before the operation.
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Urodynamic investigations (stated above)
|
|
Experimental: After i-STOP
Data obtained after the operation.
|
Urodynamic investigations (stated above)
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Experimental: Aged patient before i-STOP
Data obtained before the operation.
|
Urodynamic investigations (stated above)
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Experimental: Aged patient after i-STOP
Data obtained after the operation.
|
Urodynamic investigations (stated above)
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Experimental: Young patient before i-STOP
Data obtained before the operation.
|
Urodynamic investigations (stated above)
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Experimental: Young patient after i-STOP
Data obtained after the operation.
|
Urodynamic investigations (stated above)
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Experimental: Menopausal patient before i-STOP
Data obtained before the operation.
|
Urodynamic investigations (stated above)
|
|
Experimental: Menopausal patient after i-STOP
Data obtained after the operation.
|
Urodynamic investigations (stated above)
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Experimental: Pre-menopausal patient before i-STOP
Data obtained before the operation.
|
Urodynamic investigations (stated above)
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Experimental: Pre-menopausal patient after i-STOP
Data obtained after the operation.
|
Urodynamic investigations (stated above)
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|
Experimental: Before mini Arc
Data obtained before the operation.
|
Urodynamic investigations (stated above)
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Experimental: After mini Arc
Data obtained after the operation.
|
Urodynamic investigations (stated above)
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Experimental: Age patient before mini Arc
Data obtained before the operation.
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Urodynamic investigations (stated above)
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Experimental: Age patient after mini Arc
Data obtained after the operation.
|
Urodynamic investigations (stated above)
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Experimental: Young before mini Arc
Data obtained before the operation.
|
Urodynamic investigations (stated above)
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Experimental: Young patient after mini Arc
Data obtained after the operation.
|
Urodynamic investigations (stated above)
|
|
Experimental: Menopausal patient before mini Arc
Data obtained before the operation.
|
Urodynamic investigations (stated above)
|
|
Experimental: Menopausal patient after mini Arc
Data obtained after the operation.
|
Urodynamic investigations (stated above)
|
|
Experimental: Pre-menopausal before mini Arc
Data obtained before the operation.
|
Urodynamic investigations (stated above)
|
|
Experimental: Pre-menopausal patient after mini Arc
Data obtained after the operation.
|
Urodynamic investigations (stated above)
|
|
Experimental: Before Solyx sling
Data obtained before the operation
|
Urodynamic investigations (stated above.)
|
|
Experimental: After Solyx sling
Data obtained before the operation
|
Urodynamic investigations (stated above.)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure-volume study
Time Frame: within a voiding cycle (a cycle is about 30 to 60 minutes)
|
urine leakage.
|
within a voiding cycle (a cycle is about 30 to 60 minutes)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Yi-Shing Leu, M.D., Department of Ear, Nose, and Throat, MacKay Memorial Hospital, Taipei, Taiwan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
- Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7(2):81-5; discussion 85-6. doi: 10.1007/BF01902378.
- Abrams P, Andersson KE, Apostolidis A, Birder L, Bliss D, Brubaker L, Cardozo L, Castro-Diaz D, O'Connell PR, Cottenden A, Cotterill N, de Ridder D, Dmochowski R, Dumoulin C, Fader M, Fry C, Goldman H, Hanno P, Homma Y, Khullar V, Maher C, Milsom I, Newman D, Nijman RJM, Rademakers K, Robinson D, Rosier P, Rovner E, Salvatore S, Takeda M, Wagg A, Wagner T, Wein A; members of the committees. 6th International Consultation on Incontinence. Recommendations of the International Scientific Committee: EVALUATION AND TREATMENT OF URINARY INCONTINENCE, PELVIC ORGAN PROLAPSE AND FAECAL INCONTINENCE. Neurourol Urodyn. 2018 Sep;37(7):2271-2272. doi: 10.1002/nau.23551. Epub 2018 Aug 14. No abstract available.
- Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
- de Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol. 2003 Dec;44(6):724-30. doi: 10.1016/j.eururo.2003.09.003.
- Atis G, Arisan S, Ozagari A, Caskurlu T, Dalkilinc A, Ergenekon E. Tissue reaction of the rat urinary bladder to synthetic mesh materials. ScientificWorldJournal. 2009 Oct 2;9:1046-51. doi: 10.1100/tsw.2009.120.
- Hsiao SM, Kuo HC. Predictors of further anti-incontinence interventions or transvaginal urethrolysis after a pubovaginal sling procedure in women with and without neurologic disorders. J Formos Med Assoc. 2021 Jul;120(7):1464-1477. doi: 10.1016/j.jfma.2020.12.029. Epub 2021 Jan 16.
- Huang WC, Lau HH, Su TH. Did surgical failure and complications affect incontinence-related quality of life in women after transobturator sling procedure? Taiwan J Obstet Gynecol. 2018 Apr;57(2):295-299. doi: 10.1016/j.tjog.2018.02.020.
- Medina CA, Costantini E, Petri E, Mourad S, Singla A, Rodriguez-Colorado S, Ortiz OC, Doumouchtsis SK. Evaluation and surgery for stress urinary incontinence: A FIGO working group report. Neurourol Urodyn. 2017 Feb;36(2):518-528. doi: 10.1002/nau.22960. Epub 2016 Mar 7.
- Schimpf MO, Rahn DD, Wheeler TL, Patel M, White AB, Orejuela FJ, El-Nashar SA, Margulies RU, Gleason JL, Aschkenazi SO, Mamik MM, Ward RM, Balk EM, Sung VW; Society of Gynecologic Surgeons Systematic Review Group. Sling surgery for stress urinary incontinence in women: a systematic review and metaanalysis. Am J Obstet Gynecol. 2014 Jul;211(1):71.e1-71.e27. doi: 10.1016/j.ajog.2014.01.030. Epub 2014 Jan 30.
- Waltregny D, Gaspar Y, Reul O, Hamida W, Bonnet P, de Leval J. TVT-O for the treatment of female stress urinary incontinence: results of a prospective study after a 3-year minimum follow-up. Eur Urol. 2008 Feb;53(2):401-8. doi: 10.1016/j.eururo.2007.08.021. Epub 2007 Aug 21.
- Lau HH, Lai CY, Peng HY, Hsieh MC, Su TH, Lee JJ, Lin TB. Modification of bladder thermodynamics in stress urinary incontinence patients submitted to trans-obturator tape: A retrospective study based on urodynamic assessment. Front Bioeng Biotechnol. 2022 Aug 19;10:912602. doi: 10.3389/fbioe.2022.912602. eCollection 2022.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 8, 2021
Primary Completion (Estimated)
March 1, 2026
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
February 12, 2022
First Submitted That Met QC Criteria
February 23, 2022
First Posted (Actual)
February 24, 2022
Study Record Updates
Last Update Posted (Estimated)
September 5, 2025
Last Update Submitted That Met QC Criteria
August 30, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Incontinence
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Incontinence, Stress
Other Study ID Numbers
- 20MMHIS410e
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
For we uncertain if this might violate personal information laws in our country.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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