Efficacy/Safety of Midurethral Sling

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Procedure: Urodynamic investigations before and after a trans-obturator tape 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 an i-STOP mini adjustable sling protocol.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure-volume study | urine leakage. | within a voiding cycle (a cycle is about 30 to 60 minutes) |