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NCT Number: NCT05255289

Efficacy/Safety of Midurethral Sling

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.

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Key information

Age range

30 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology

New Taipei City, Taiwan

Location status: Recruiting

Location contact

Hui-Hsuan Lau, PhD

CONTACT

[email protected]

+886 975-835928

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Urodynamic investigations before and after a trans-obturator tape protocol.

Procedure

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

Urodynamic investigations (stated above.)

Urodynamic investigations before and after a mini Arc protocol.

Procedure

Urodynamic investigations (stated above)

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

Procedure

Urodynamic investigations (stated above)

Urodynamic investigations before and after an Solyx sling protocol.

Procedure

Urodynamic investigations (stated above.)

Primary outcomes

  1. Pressure-volume study

    Time frame: within a voiding cycle (a cycle is about 30 to 60 minutes)

    urine leakage.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui-Hsuan Lau, M.D.

CONTACT

[email protected]

+886-975-835928

Sponsors and collaborators

Lead sponsor

Mackay Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2022
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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