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Efficacy/Safety of Midurethral Sling

Evaluation of Efficacy and Safety of Midurethral Slings in Women With Stress Incontinence

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05255289
Enrollment
200
Registered
2022-02-24
Start date
2021-03-08
Completion date
2026-03-31
Last updated
2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

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.

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.

Interventions

PROCEDUREUrodynamic 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.)

PROCEDUREUrodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)

Urodynamic investigations (stated above.)

PROCEDUREUrodynamic investigations before and after a mini Arc protocol.

Urodynamic investigations (stated above)

PROCEDUREUrodynamic investigations before and after an i-STOP mini adjustable sling protocol.

Urodynamic investigations (stated above)

PROCEDUREUrodynamic investigations before and after an Solyx sling protocol.

Urodynamic investigations (stated above.)

Sponsors

Mackay Medical College
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of stress urinary incontience * Have urodynamic investigations before and after operation.

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Pressure-volume studywithin a voiding cycle (a cycle is about 30 to 60 minutes)urine leakage.

Countries

Taiwan

Contacts

Primary ContactHui-Hsuan Lau, M.D.
huihsuan1220@gmail.com+886-975-835928

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026