Stress Urinary IncontinenceNCT05255289
Efficacy/Safety of Midurethral Sling
A study testing Urodynamic investigations before and after a trans-obturator tape protocol., Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) and Urodynamic investigations before and after a mini Arc protocol. in people with Stress Urinary Incontinence, run by Mackay Medical College at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 100 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Urodynamic investigations before and after a trans-obturator tape protocol., Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) and Urodynamic investigations before and after a mini Arc protocol.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Mar 2021to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of stress urinary incontience
- Have urodynamic investigations before and after operation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology
New Taipei City
Hui-Hsuan Lau, PhD, +886 975-835928, huihsuan1220@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Urodynamic investigations before and after a trans-obturator tape protocol., Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O), Urodynamic investigations before and after a mini Arc protocol., Urodynamic investigations before and after an i-STOP mini adjustable sling protocol., Urodynamic investigations before and after an Solyx sling protocol.
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urodynamic investigations before and after a trans-obturator tape protocol.Procedure or surgery
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)Procedure or surgery
Urodynamic investigations (stated above.)
Urodynamic investigations before and after a mini Arc protocol.Procedure or surgery
Urodynamic investigations (stated above)
Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.Procedure or surgery
Urodynamic investigations (stated above)
Urodynamic investigations before and after an Solyx sling protocol.Procedure or surgery
Urodynamic investigations (stated above.)
| Study group | Role | What they receive |
|---|---|---|
| Before TOT | Experimental | Data obtained before the operation Receives: Procedure: Urodynamic investigations before and after a trans-obturator tape protocol. |
| After TOT | Experimental | Data obtained after the operation Receives: Procedure: Urodynamic investigations before and after a trans-obturator tape protocol. |
| Before TVT-O | Experimental | Data obtained before the operation. Receives: Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) |
| After TVT-O | Experimental | Data obtained after the operation. Receives: Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) |
| Aged patient (>50 y/o) before TVT-O | Experimental | Data obtained before the operation. Receives: Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) |
| Aged patient (>50 y/o) after TVT-O | Experimental | Data obtained after the operation. Receives: Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) |
| Young patients (<50 y/o) before TVT-O | Experimental | Data obtained before the operation. Receives: Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) |
| Young patients (<50 y/o) after TVT-O | Experimental | Data obtained after the operation. Receives: Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) |
| Menopausal patient before TVT-O | Experimental | Data obtained before the operation. Receives: Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) |
| Menopausal patient after TVT-O | Experimental | Data obtained after the operation. Receives: Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) |
| Pre-menopausal patient before TVT-O | Experimental | Data obtained before the operation. Receives: Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) |
| Pre-menopausal patients after TVT-O | Experimental | Data obtained after the operation. Receives: Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) |
| Before i-STOP | Experimental | Data obtained before the operation. Receives: Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. |
| After i-STOP | Experimental | Data obtained after the operation. Receives: Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. |
| Aged patient before i-STOP | Experimental | Data obtained before the operation. Receives: Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. |
| Aged patient after i-STOP | Experimental | Data obtained after the operation. Receives: Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. |
| Young patient before i-STOP | Experimental | Data obtained before the operation. Receives: Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. |
| Young patient after i-STOP | Experimental | Data obtained after the operation. Receives: Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. |
| Menopausal patient before i-STOP | Experimental | Data obtained before the operation. Receives: Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. |
| Menopausal patient after i-STOP | Experimental | Data obtained after the operation. Receives: Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. |
| Pre-menopausal patient before i-STOP | Experimental | Data obtained before the operation. Receives: Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. |
| Pre-menopausal patient after i-STOP | Experimental | Data obtained after the operation. Receives: Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. |
| Before mini Arc | Experimental | Data obtained before the operation. Receives: Procedure: Urodynamic investigations before and after a mini Arc protocol. |
| After mini Arc | Experimental | Data obtained after the operation. Receives: Procedure: Urodynamic investigations before and after a mini Arc protocol. |
| Age patient before mini Arc | Experimental | Data obtained before the operation. Receives: Procedure: Urodynamic investigations before and after a mini Arc protocol. |
| Age patient after mini Arc | Experimental | Data obtained after the operation. Receives: Procedure: Urodynamic investigations before and after a mini Arc protocol. |
| Young before mini Arc | Experimental | Data obtained before the operation. Receives: Procedure: Urodynamic investigations before and after a mini Arc protocol. |
| Young patient after mini Arc | Experimental | Data obtained after the operation. Receives: Procedure: Urodynamic investigations before and after a mini Arc protocol. |
| Menopausal patient before mini Arc | Experimental | Data obtained before the operation. Receives: Procedure: Urodynamic investigations before and after a mini Arc protocol. |
| Menopausal patient after mini Arc | Experimental | Data obtained after the operation. Receives: Procedure: Urodynamic investigations before and after a mini Arc protocol. |
| Pre-menopausal before mini Arc | Experimental | Data obtained before the operation. Receives: Procedure: Urodynamic investigations before and after a mini Arc protocol. |
| Pre-menopausal patient after mini Arc | Experimental | Data obtained after the operation. Receives: Procedure: Urodynamic investigations before and after a mini Arc protocol. |
| Before Solyx sling | Experimental | Data obtained before the operation Receives: Procedure: Urodynamic investigations before and after an Solyx sling protocol. |
| After Solyx sling | Experimental | Data obtained before the operation Receives: Procedure: Urodynamic investigations before and after an Solyx sling protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure-volume study
urine leakage.
Measured: within a voiding cycle (a cycle is about 30 to 60 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start8 Mar 2021
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin-Tsung Shen, Mackay Medical College
- Investigators
- Yi-Shing Leu, M.D., Study chair, Department of Ear, Nose, and Throat, MacKay Memorial Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255289
- Sponsor's protocol ID
- 20MMHIS410e
- Status last verified
- Aug 2025
- First submitted
- 12 Feb 2022
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For we uncertain if this might violate personal information laws in our country.
Publications
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.
PubMed 30106223Abrams 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.
PubMed 11857671Abrams 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.
PubMed 12559262Atis 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.
PubMed 19802500de 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.
PubMed 14644127Hsiao 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.
PubMed 33468403Huang 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.
PubMed 29673676Medina 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.
PubMed 26950893Schimpf 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.
PubMed 24487005Ulmsten 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.
PubMed 8798092Waltregny 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.
PubMed 17728052Lau 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.
PubMed 36061421
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Midurethral Slings in Women With Stress Incontinence
- ClinicalTrials.gov ID
- NCT05255289
- Acronym / sponsor ID
- 20MMHIS410e
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mackay Medical CollegeUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 24 Feb 2022 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 34
| Arm | Type | Receives |
|---|---|---|
| Before TOT | Experimental | Procedure: Urodynamic investigations before and after a trans-obturator tape protocol.Data obtained before the operation |
| After TOT | Experimental | Procedure: Urodynamic investigations before and after a trans-obturator tape protocol.Data obtained after the operation |
| Before TVT-O | Experimental | Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)Data obtained before the operation. |
| After TVT-O | Experimental | Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)Data obtained after the operation. |
| Aged patient (>50 y/o) before TVT-O | Experimental | Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)Data obtained before the operation. |
| Aged patient (>50 y/o) after TVT-O | Experimental | Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)Data obtained after the operation. |
| Young patients (<50 y/o) before TVT-O | Experimental | Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)Data obtained before the operation. |
| Young patients (<50 y/o) after TVT-O | Experimental | Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)Data obtained after the operation. |
| Menopausal patient before TVT-O | Experimental | Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)Data obtained before the operation. |
| Menopausal patient after TVT-O | Experimental | Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)Data obtained after the operation. |
| Pre-menopausal patient before TVT-O | Experimental | Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)Data obtained before the operation. |
| Pre-menopausal patients after TVT-O | Experimental | Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)Data obtained after the operation. |
| Before i-STOP | Experimental | Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.Data obtained before the operation. |
| After i-STOP | Experimental | Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.Data obtained after the operation. |
| Aged patient before i-STOP | Experimental | Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.Data obtained before the operation. |
| Aged patient after i-STOP | Experimental | Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.Data obtained after the operation. |
| Young patient before i-STOP | Experimental | Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.Data obtained before the operation. |
| Young patient after i-STOP | Experimental | Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.Data obtained after the operation. |
| Menopausal patient before i-STOP | Experimental | Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.Data obtained before the operation. |
| Menopausal patient after i-STOP | Experimental | Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.Data obtained after the operation. |
| Pre-menopausal patient before i-STOP | Experimental | Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.Data obtained before the operation. |
| Pre-menopausal patient after i-STOP | Experimental | Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.Data obtained after the operation. |
| Before mini Arc | Experimental | Procedure: Urodynamic investigations before and after a mini Arc protocol.Data obtained before the operation. |
| After mini Arc | Experimental | Procedure: Urodynamic investigations before and after a mini Arc protocol.Data obtained after the operation. |
| Age patient before mini Arc | Experimental | Procedure: Urodynamic investigations before and after a mini Arc protocol.Data obtained before the operation. |
| Age patient after mini Arc | Experimental | Procedure: Urodynamic investigations before and after a mini Arc protocol.Data obtained after the operation. |
| Young before mini Arc | Experimental | Procedure: Urodynamic investigations before and after a mini Arc protocol.Data obtained before the operation. |
| Young patient after mini Arc | Experimental | Procedure: Urodynamic investigations before and after a mini Arc protocol.Data obtained after the operation. |
| Menopausal patient before mini Arc | Experimental | Procedure: Urodynamic investigations before and after a mini Arc protocol.Data obtained before the operation. |
| Menopausal patient after mini Arc | Experimental | Procedure: Urodynamic investigations before and after a mini Arc protocol.Data obtained after the operation. |
| Pre-menopausal before mini Arc | Experimental | Procedure: Urodynamic investigations before and after a mini Arc protocol.Data obtained before the operation. |
| Pre-menopausal patient after mini Arc | Experimental | Procedure: Urodynamic investigations before and after a mini Arc protocol.Data obtained after the operation. |
| Before Solyx sling | Experimental | Procedure: Urodynamic investigations before and after an Solyx sling protocol.Data obtained before the operation |
| After Solyx sling | Experimental | Procedure: Urodynamic investigations before and after an Solyx sling protocol.Data obtained before the operation |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of stress urinary incontience
- Have urodynamic investigations before and after operation.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| 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.) | Procedure or surgery | After TOT, Before TOT |
| Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)Urodynamic investigations (stated above.) | Procedure or surgery | After TVT-O, Aged patient (>50 y/o) after TVT-O, Aged patient (>50 y/o) before TVT-O, Before TVT-O, Menopausal patient after TVT-O, Menopausal patient before TVT-O, Pre-menopausal patient before TVT-O, Pre-menopausal patients after TVT-O, Young patients (<50 y/o) after TVT-O, Young patients (<50 y/o) before TVT-O |
| Urodynamic investigations before and after a mini Arc protocol.Urodynamic investigations (stated above) | Procedure or surgery | After mini Arc, Age patient after mini Arc, Age patient before mini Arc, Before mini Arc, Menopausal patient after mini Arc, Menopausal patient before mini Arc, Pre-menopausal before mini Arc, Pre-menopausal patient after mini Arc, Young before mini Arc, Young patient after mini Arc |
| Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.Urodynamic investigations (stated above) | Procedure or surgery | After i-STOP, Aged patient after i-STOP, Aged patient before i-STOP, Before i-STOP, Menopausal patient after i-STOP, Menopausal patient before i-STOP, Pre-menopausal patient after i-STOP, Pre-menopausal patient before i-STOP, Young patient after i-STOP, Young patient before i-STOP |
| Urodynamic investigations before and after an Solyx sling protocol.Urodynamic investigations (stated above.) | Procedure or surgery | After Solyx sling, Before Solyx sling |
Primary outcome
Pressure-volume study
Time frame: within a voiding cycle (a cycle is about 30 to 60 minutes)
urine leakage.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Background: PubMed 30106223Abrams 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.
- Background: PubMed 11857671Abrams 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.
- Background: PubMed 12559262Abrams 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.
- Background: PubMed 19802500Atis 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.
- Background: PubMed 14644127de 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.
- Background: PubMed 33468403Hsiao 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.
- Background: PubMed 29673676Huang 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.
- Background: PubMed 26950893Medina 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.
- Background: PubMed 24487005Schimpf 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.
- Background: PubMed 8798092Ulmsten 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.
- Background: PubMed 17728052Waltregny 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.
- Derived from this study: PubMed 36061421Lau 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.
- Reported complications of tension-free vaginal tape procedures: A reviewLink provided by the sponsor.
- Individual participant dataSharing planned: No. For we uncertain if this might violate personal information laws in our country.
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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.
Yi-Shing Leu, M.D. study chair
Department of Ear, Nose, and Throat, MacKay Memorial Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urodynamic investigations before and after a trans-obturator tape protocol., Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) and Urodynamic investigations before and after a mini Arc protocol. in people with Stress Urinary Incontinence, run by Mackay Medical College at 1 site in Taiwan.
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 1 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: looking for participants now, as of the sponsor's last update on 5 Sep 2025. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui-Hsuan Lau, M.D. (+886-975-835928, huihsuan1220@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure-volume study (time frame: within a voiding cycle (a cycle is about 30 to 60 minutes)). 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 NCT05255289, which also lists 12 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 5 Sep 2025.