Efficacy/Safety of Midurethral Sling
Evaluation of Efficacy and Safety of Midurethral Slings in Women With Stress Incontinence
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 8, 2021
CompletedFirst Submitted
Initial submission to the registry
February 12, 2022
CompletedFirst Posted
Study publicly available on registry
February 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedSeptember 5, 2025
August 1, 2025
5 years
February 12, 2022
August 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Pressure-volume study
urine leakage.
within a voiding cycle (a cycle is about 30 to 60 minutes)
Study Arms (34)
Before TOT
EXPERIMENTALData obtained before the operation
After TOT
EXPERIMENTALData obtained after the operation
Before TVT-O
EXPERIMENTALData obtained before the operation.
After TVT-O
EXPERIMENTALData obtained after the operation.
Aged patient (>50 y/o) before TVT-O
EXPERIMENTALData obtained before the operation.
Aged patient (>50 y/o) after TVT-O
EXPERIMENTALData obtained after the operation.
Young patients (<50 y/o) before TVT-O
EXPERIMENTALData obtained before the operation.
Young patients (<50 y/o) after TVT-O
EXPERIMENTALData obtained after the operation.
Menopausal patient before TVT-O
EXPERIMENTALData obtained before the operation.
Menopausal patient after TVT-O
EXPERIMENTALData obtained after the operation.
Pre-menopausal patient before TVT-O
EXPERIMENTALData obtained before the operation.
Pre-menopausal patients after TVT-O
EXPERIMENTALData obtained after the operation.
Before i-STOP
EXPERIMENTALData obtained before the operation.
After i-STOP
EXPERIMENTALData obtained after the operation.
Aged patient before i-STOP
EXPERIMENTALData obtained before the operation.
Aged patient after i-STOP
EXPERIMENTALData obtained after the operation.
Young patient before i-STOP
EXPERIMENTALData obtained before the operation.
Young patient after i-STOP
EXPERIMENTALData obtained after the operation.
Menopausal patient before i-STOP
EXPERIMENTALData obtained before the operation.
Menopausal patient after i-STOP
EXPERIMENTALData obtained after the operation.
Pre-menopausal patient before i-STOP
EXPERIMENTALData obtained before the operation.
Pre-menopausal patient after i-STOP
EXPERIMENTALData obtained after the operation.
Before mini Arc
EXPERIMENTALData obtained before the operation.
After mini Arc
EXPERIMENTALData obtained after the operation.
Age patient before mini Arc
EXPERIMENTALData obtained before the operation.
Age patient after mini Arc
EXPERIMENTALData obtained after the operation.
Young before mini Arc
EXPERIMENTALData obtained before the operation.
Young patient after mini Arc
EXPERIMENTALData obtained after the operation.
Menopausal patient before mini Arc
EXPERIMENTALData obtained before the operation.
Menopausal patient after mini Arc
EXPERIMENTALData obtained after the operation.
Pre-menopausal before mini Arc
EXPERIMENTALData obtained before the operation.
Pre-menopausal patient after mini Arc
EXPERIMENTALData obtained after the operation.
Before Solyx sling
EXPERIMENTALData obtained before the operation
After Solyx sling
EXPERIMENTALData obtained before the operation
Interventions
Urodynamic investigations (stated above.)
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.)
Urodynamic investigations (stated above)
Urodynamic investigations (stated above)
Urodynamic investigations (stated above.)
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of stress urinary incontience
- Have urodynamic investigations before and after operation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics and Gynecology
New Taipei City, Taiwan
Related Publications (12)
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.
PMID: 30106223BACKGROUNDAbrams 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.
PMID: 11857671BACKGROUNDAbrams 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.
PMID: 12559262BACKGROUNDAtis 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.
PMID: 19802500BACKGROUNDde 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.
PMID: 14644127BACKGROUNDHsiao 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.
PMID: 33468403BACKGROUNDHuang 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.
PMID: 29673676BACKGROUNDMedina 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.
PMID: 26950893BACKGROUNDSchimpf 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.
PMID: 24487005BACKGROUNDUlmsten 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.
PMID: 8798092BACKGROUNDWaltregny 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.
PMID: 17728052BACKGROUNDLau 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.
PMID: 36061421DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yi-Shing Leu, M.D.
Department of Ear, Nose, and Throat, MacKay Memorial Hospital, Taipei, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of administration
Study Record Dates
First Submitted
February 12, 2022
First Posted
February 24, 2022
Study Start
March 8, 2021
Primary Completion
March 1, 2026
Study Completion
March 1, 2026
Last Updated
September 5, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
For we uncertain if this might violate personal information laws in our country.