Health TrialsbyHealthPanel

Efficacy/Safety of Midurethral Sling

ConditionStress Urinary Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-100
SponsorMackay Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of stress urinary incontience

Have urodynamic investigations before and after operation.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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/Surgery

    Urodynamic investigations (stated above.)

  • Urodynamic investigations before and after a mini Arc protocol.

    Procedure/Surgery

    Urodynamic investigations (stated above)

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

    Procedure/Surgery

    Urodynamic investigations (stated above)

  • Urodynamic investigations before and after an Solyx sling protocol.

    Procedure/Surgery

    Urodynamic investigations (stated above.)

Treatment groups

200 Participants
are divided into 34 treatment groups

34

Treatment groups

See each treatment group below.

Group A: Before TOTExperimental treatment 1 intervention
Group B: After TOTExperimental treatment 1 intervention
Group C: Before TVT-OExperimental treatment 1 intervention
Group D: After TVT-OExperimental treatment 1 intervention
Group E: Aged patient (>50 y/o) before TVT-OExperimental treatment 1 intervention
Group F: Aged patient (>50 y/o) after TVT-OExperimental treatment 1 intervention
Group G: Young patients (<50 y/o) before TVT-OExperimental treatment 1 intervention
Group H: Young patients (<50 y/o) after TVT-OExperimental treatment 1 intervention
Group I: Menopausal patient before TVT-OExperimental treatment 1 intervention
Group J: Menopausal patient after TVT-OExperimental treatment 1 intervention
Group K: Pre-menopausal patient before TVT-OExperimental treatment 1 intervention
Group L: Pre-menopausal patients after TVT-OExperimental treatment 1 intervention
Group M: Before i-STOPExperimental treatment 1 intervention
Group N: After i-STOPExperimental treatment 1 intervention
Group O: Aged patient before i-STOPExperimental treatment 1 intervention
Group P: Aged patient after i-STOPExperimental treatment 1 intervention
Group Q: Young patient before i-STOPExperimental treatment 1 intervention
Group R: Young patient after i-STOPExperimental treatment 1 intervention
Group S: Menopausal patient before i-STOPExperimental treatment 1 intervention
Group T: Menopausal patient after i-STOPExperimental treatment 1 intervention
Group U: Pre-menopausal patient before i-STOPExperimental treatment 1 intervention
Group V: Pre-menopausal patient after i-STOPExperimental treatment 1 intervention
Group W: Before mini ArcExperimental treatment 1 intervention
Group X: After mini ArcExperimental treatment 1 intervention
Group Y: Age patient before mini ArcExperimental treatment 1 intervention
Group Z: Age patient after mini ArcExperimental treatment 1 intervention
Group [: Young before mini ArcExperimental treatment 1 intervention
Group \: Young patient after mini ArcExperimental treatment 1 intervention
Group ]: Menopausal patient before mini ArcExperimental treatment 1 intervention
Group ^: Menopausal patient after mini ArcExperimental treatment 1 intervention
Group _: Pre-menopausal before mini ArcExperimental treatment 1 intervention
Group `: Pre-menopausal patient after mini ArcExperimental treatment 1 intervention
Group a: Before Solyx slingExperimental treatment 1 intervention
Group b: After Solyx slingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pressure-volume study

urine leakage.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mackay Medical College

Lead sponsor

Source ClinicalTrials.gov
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