Efficacy/Safety of Midurethral Sling
- Conditions
- Stress Urinary Incontinence
- Interventions
- Procedure: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.Procedure: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)Procedure: Urodynamic investigations before and after a mini Arc protocol.Procedure: Urodynamic investigations before and after a trans-obturator tape protocol.
- Registration Number
- NCT05255289
- Lead Sponsor
- Mackay Medical College
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- Clinical diagnosis of stress urinary incontience
- Have urodynamic investigations before and after operation.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Before i-STOP Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. Data obtained before the operation. After TVT-O 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 Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) Data obtained before the operation. Pre-menopausal patient before TVT-O Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) Data obtained before the operation. Pre-menopausal patient after i-STOP Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. Data obtained after the operation. Age patient before mini Arc Urodynamic investigations before and after a mini Arc protocol. Data obtained before the operation. Young patients (<50 y/o) before TVT-O Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) Data obtained before the operation. After TOT Urodynamic investigations before and after a trans-obturator tape protocol. Data obtained after the operation Before TVT-O Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) Data obtained before the operation. Menopausal patient after TVT-O Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) Data obtained after the operation. Young patients (<50 y/o) after TVT-O Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) Data obtained after the operation. After i-STOP Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. Data obtained after the operation. Aged patient (>50 y/o) after TVT-O Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) Data obtained after the operation. Aged patient after i-STOP Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. Data obtained after the operation. Menopausal patient before i-STOP Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. Data obtained before the operation. Pre-menopausal patient before i-STOP Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. Data obtained before the operation. Menopausal patient before TVT-O Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) Data obtained before the operation. Pre-menopausal before mini Arc Urodynamic investigations before and after a mini Arc protocol. Data obtained before the operation. Pre-menopausal patients after TVT-O Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) Data obtained after the operation. Aged patient before i-STOP Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. Data obtained before the operation. Menopausal patient before mini Arc Urodynamic investigations before and after a mini Arc protocol. Data obtained before the operation. Before TOT Urodynamic investigations before and after a trans-obturator tape protocol. Data obtained before the operation Before mini Arc Urodynamic investigations before and after a mini Arc protocol. Data obtained before the operation. Young patient before i-STOP Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. Data obtained before the operation. After mini Arc Urodynamic investigations before and after a mini Arc protocol. Data obtained after the operation. Young patient after mini Arc Urodynamic investigations before and after a mini Arc protocol. Data obtained after the operation. Young patient after i-STOP Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. Data obtained after the operation. Menopausal patient after i-STOP Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. Data obtained after the operation. Age patient after mini Arc Urodynamic investigations before and after a mini Arc protocol. Data obtained after the operation. Young before mini Arc Urodynamic investigations before and after a mini Arc protocol. Data obtained before the operation. Menopausal patient after mini Arc Urodynamic investigations before and after a mini Arc protocol. Data obtained after the operation. Pre-menopausal patient after mini Arc Urodynamic investigations before and after a mini Arc protocol. Data obtained after the operation.
- Primary Outcome Measures
Name Time Method Pressure-volume study within a voiding cycle (a cycle is about 30 to 60 minutes) urine leakage.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Obstetrics and Gynecology
🇨🇳New Taipei City, Taiwan