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Efficacy/Safety of Midurethral Sling

NCT05255289 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-09-05

No results posted yet for this study

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.

Conditions

  • Stress Urinary Incontinence

Interventions

PROCEDURE

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

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

Urodynamic investigations (stated above.)

PROCEDURE

Urodynamic investigations before and after a mini Arc protocol.

Urodynamic investigations (stated above)

PROCEDURE

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

Urodynamic investigations (stated above)

PROCEDURE

Urodynamic investigations before and after an Solyx sling protocol.

Urodynamic investigations (stated above.)

Sponsors & Collaborators

  • Mackay Medical College

    lead OTHER

Principal Investigators

  • Yi-Shing Leu, M.D. · Department of Ear, Nose, and Throat, MacKay Memorial Hospital, Taipei, Taiwan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-08
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05255289 on ClinicalTrials.gov