Study Results
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Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2021-03-08
2026-03-31
Brief Summary
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Trans-obturator Mid-urethral Sling and the Single-incision Sling in Women With Stress Urinary Incontinence
NCT02506309
A Comparison of the Retropubic (TVT) With the Transobturator Sling Operation in the Treatment of Female Stress Urinary Incontinence or Stress Dominated Mixed Urinary Incontinence
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Mesh-Free Versus Mesh-Based Surgery for Female Stress Urinary Incontinence: A Prospective Comparison of Pubo-Urethral Ligament Plication and Transobturator Tape
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Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence
NCT02263534
Randomised Controlled Trial Comparing Tension-Free Vaginal Tape (TVT), Pelvicol & Autologous Slings for Stress Urinary Incontinence(SUI)
NCT01057550
Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Before TOT
Data obtained before the operation
Urodynamic investigations before and after a trans-obturator tape protocol.
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.)
After TOT
Data obtained after the operation
Urodynamic investigations before and after a trans-obturator tape protocol.
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.)
Before TVT-O
Data obtained before the operation.
Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Urodynamic investigations (stated above.)
After TVT-O
Data obtained after the operation.
Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Urodynamic investigations (stated above.)
Aged patient (>50 y/o) before TVT-O
Data obtained before the operation.
Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Urodynamic investigations (stated above.)
Aged patient (>50 y/o) after TVT-O
Data obtained after the operation.
Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Urodynamic investigations (stated above.)
Young patients (<50 y/o) before TVT-O
Data obtained before the operation.
Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Urodynamic investigations (stated above.)
Young patients (<50 y/o) after TVT-O
Data obtained after the operation.
Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Urodynamic investigations (stated above.)
Menopausal patient before TVT-O
Data obtained before the operation.
Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Urodynamic investigations (stated above.)
Menopausal patient after TVT-O
Data obtained after the operation.
Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Urodynamic investigations (stated above.)
Pre-menopausal patient before TVT-O
Data obtained before the operation.
Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Urodynamic investigations (stated above.)
Pre-menopausal patients after TVT-O
Data obtained after the operation.
Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Urodynamic investigations (stated above.)
Before i-STOP
Data obtained before the operation.
Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Urodynamic investigations (stated above)
After i-STOP
Data obtained after the operation.
Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Urodynamic investigations (stated above)
Aged patient before i-STOP
Data obtained before the operation.
Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Urodynamic investigations (stated above)
Aged patient after i-STOP
Data obtained after the operation.
Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Urodynamic investigations (stated above)
Young patient before i-STOP
Data obtained before the operation.
Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Urodynamic investigations (stated above)
Young patient after i-STOP
Data obtained after the operation.
Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Urodynamic investigations (stated above)
Menopausal patient before i-STOP
Data obtained before the operation.
Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Urodynamic investigations (stated above)
Menopausal patient after i-STOP
Data obtained after the operation.
Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Urodynamic investigations (stated above)
Pre-menopausal patient before i-STOP
Data obtained before the operation.
Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Urodynamic investigations (stated above)
Pre-menopausal patient after i-STOP
Data obtained after the operation.
Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Urodynamic investigations (stated above)
Before mini Arc
Data obtained before the operation.
Urodynamic investigations before and after a mini Arc protocol.
Urodynamic investigations (stated above)
After mini Arc
Data obtained after the operation.
Urodynamic investigations before and after a mini Arc protocol.
Urodynamic investigations (stated above)
Age patient before mini Arc
Data obtained before the operation.
Urodynamic investigations before and after a mini Arc protocol.
Urodynamic investigations (stated above)
Age patient after mini Arc
Data obtained after the operation.
Urodynamic investigations before and after a mini Arc protocol.
Urodynamic investigations (stated above)
Young before mini Arc
Data obtained before the operation.
Urodynamic investigations before and after a mini Arc protocol.
Urodynamic investigations (stated above)
Young patient after mini Arc
Data obtained after the operation.
Urodynamic investigations before and after a mini Arc protocol.
Urodynamic investigations (stated above)
Menopausal patient before mini Arc
Data obtained before the operation.
Urodynamic investigations before and after a mini Arc protocol.
Urodynamic investigations (stated above)
Menopausal patient after mini Arc
Data obtained after the operation.
Urodynamic investigations before and after a mini Arc protocol.
Urodynamic investigations (stated above)
Pre-menopausal before mini Arc
Data obtained before the operation.
Urodynamic investigations before and after a mini Arc protocol.
Urodynamic investigations (stated above)
Pre-menopausal patient after mini Arc
Data obtained after the operation.
Urodynamic investigations before and after a mini Arc protocol.
Urodynamic investigations (stated above)
Before Solyx sling
Data obtained before the operation
Urodynamic investigations before and after an Solyx sling protocol.
Urodynamic investigations (stated above.)
After Solyx sling
Data obtained before the operation
Urodynamic investigations before and after an Solyx sling protocol.
Urodynamic investigations (stated above.)
Interventions
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Urodynamic investigations before and after a trans-obturator tape protocol.
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 before and after a tension-free vaginal tape-obturator (TVT-O)
Urodynamic investigations (stated above.)
Urodynamic investigations before and after a mini Arc protocol.
Urodynamic investigations (stated above)
Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Urodynamic investigations (stated above)
Urodynamic investigations before and after an Solyx sling protocol.
Urodynamic investigations (stated above.)
Eligibility Criteria
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Inclusion Criteria
* Have urodynamic investigations before and after operation.
30 Years
100 Years
FEMALE
No
Sponsors
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Mackay Medical College
OTHER
Responsible Party
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Chin-Tsung Shen
Head of administration
Principal Investigators
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Yi-Shing Leu, M.D.
Role: STUDY_CHAIR
Department of Ear, Nose, and Throat, MacKay Memorial Hospital, Taipei, Taiwan
Locations
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Department of Obstetrics and Gynecology
New Taipei City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Related Links
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Reported complications of tension-free vaginal tape procedures: A review
Other Identifiers
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20MMHIS410e
Identifier Type: -
Identifier Source: org_study_id
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