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Efficacy/Safety of Midurethral Sling

M

Mackay Medical College

Status

Enrolling

Conditions

Stress Urinary Incontinence

Treatments

Procedure: Urodynamic investigations before and after a trans-obturator tape protocol.
Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Procedure: Urodynamic investigations before and after a mini Arc protocol.
Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Procedure: Urodynamic investigations before and after an Solyx sling protocol.

Study type

Interventional

Funder types

Other

Identifiers

NCT05255289
20MMHIS410e

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

Female

Ages

30 to 100 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

200 participants in 34 patient groups

Before TOT
Experimental group
Description:
Data obtained before the operation
Treatment:
Procedure: Urodynamic investigations before and after a trans-obturator tape protocol.
After TOT
Experimental group
Description:
Data obtained after the operation
Treatment:
Procedure: Urodynamic investigations before and after a trans-obturator tape protocol.
Before TVT-O
Experimental group
Description:
Data obtained before the operation.
Treatment:
Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
After TVT-O
Experimental group
Description:
Data obtained after the operation.
Treatment:
Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Aged patient (>50 y/o) before TVT-O
Experimental group
Description:
Data obtained before the operation.
Treatment:
Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Aged patient (>50 y/o) after TVT-O
Experimental group
Description:
Data obtained after the operation.
Treatment:
Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Young patients (<50 y/o) before TVT-O
Experimental group
Description:
Data obtained before the operation.
Treatment:
Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Young patients (<50 y/o) after TVT-O
Experimental group
Description:
Data obtained after the operation.
Treatment:
Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Menopausal patient before TVT-O
Experimental group
Description:
Data obtained before the operation.
Treatment:
Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Menopausal patient after TVT-O
Experimental group
Description:
Data obtained after the operation.
Treatment:
Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Pre-menopausal patient before TVT-O
Experimental group
Description:
Data obtained before the operation.
Treatment:
Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Pre-menopausal patients after TVT-O
Experimental group
Description:
Data obtained after the operation.
Treatment:
Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Before i-STOP
Experimental group
Description:
Data obtained before the operation.
Treatment:
Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
After i-STOP
Experimental group
Description:
Data obtained after the operation.
Treatment:
Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Aged patient before i-STOP
Experimental group
Description:
Data obtained before the operation.
Treatment:
Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Aged patient after i-STOP
Experimental group
Description:
Data obtained after the operation.
Treatment:
Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Young patient before i-STOP
Experimental group
Description:
Data obtained before the operation.
Treatment:
Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Young patient after i-STOP
Experimental group
Description:
Data obtained after the operation.
Treatment:
Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Menopausal patient before i-STOP
Experimental group
Description:
Data obtained before the operation.
Treatment:
Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Menopausal patient after i-STOP
Experimental group
Description:
Data obtained after the operation.
Treatment:
Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Pre-menopausal patient before i-STOP
Experimental group
Description:
Data obtained before the operation.
Treatment:
Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Pre-menopausal patient after i-STOP
Experimental group
Description:
Data obtained after the operation.
Treatment:
Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Before mini Arc
Experimental group
Description:
Data obtained before the operation.
Treatment:
Procedure: Urodynamic investigations before and after a mini Arc protocol.
After mini Arc
Experimental group
Description:
Data obtained after the operation.
Treatment:
Procedure: Urodynamic investigations before and after a mini Arc protocol.
Age patient before mini Arc
Experimental group
Description:
Data obtained before the operation.
Treatment:
Procedure: Urodynamic investigations before and after a mini Arc protocol.
Age patient after mini Arc
Experimental group
Description:
Data obtained after the operation.
Treatment:
Procedure: Urodynamic investigations before and after a mini Arc protocol.
Young before mini Arc
Experimental group
Description:
Data obtained before the operation.
Treatment:
Procedure: Urodynamic investigations before and after a mini Arc protocol.
Young patient after mini Arc
Experimental group
Description:
Data obtained after the operation.
Treatment:
Procedure: Urodynamic investigations before and after a mini Arc protocol.
Menopausal patient before mini Arc
Experimental group
Description:
Data obtained before the operation.
Treatment:
Procedure: Urodynamic investigations before and after a mini Arc protocol.
Menopausal patient after mini Arc
Experimental group
Description:
Data obtained after the operation.
Treatment:
Procedure: Urodynamic investigations before and after a mini Arc protocol.
Pre-menopausal before mini Arc
Experimental group
Description:
Data obtained before the operation.
Treatment:
Procedure: Urodynamic investigations before and after a mini Arc protocol.
Pre-menopausal patient after mini Arc
Experimental group
Description:
Data obtained after the operation.
Treatment:
Procedure: Urodynamic investigations before and after a mini Arc protocol.
Before Solyx sling
Experimental group
Description:
Data obtained before the operation
Treatment:
Procedure: Urodynamic investigations before and after an Solyx sling protocol.
After Solyx sling
Experimental group
Description:
Data obtained before the operation
Treatment:
Procedure: Urodynamic investigations before and after an Solyx sling protocol.

Trial contacts and locations

1

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Central trial contact

Hui-Hsuan Lau, M.D.

Data sourced from clinicaltrials.gov

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