Prospective Study of Altis System With the TVTO Procedure for the Management of Stress Urinary Incontinence in Women

Study Overview
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Brief Summary
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Prospective randomized comparison of minisling (altis) with the TVTO procedure for the management of women with genuine stress urinary incontinence.

Detailed Description
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Prospective randomized study double blinded. Two group of patients consisting group A of 40 patients being operated with altis minisling and group B with 40 patients operated with TVTO procedure. All patients will be operated with epidural anesthesia. The patients participating in the study will meet the following requirements. a. Having genuine stress urinary incontinence proven by urodynamics, b. be willing to be operated and participate in the study. Exclusion criteria wil be the following: a.History of previous irradiation in the lower genital tract, b. BMI more than 30kg/m2, c.previous anti-incontinence surgery, previous vaginal surgery, e. having MUCP< 20 cm H2O or Valsava leak point pressure less than than 60 cm H2O. Patients will be allocated in each operation by an automatic system using a computer software. Primary outcome measure will be the objective cure rate at 6 months as it is assessed with cough stress test during urodynamics. Secondary outcome measures will be the subjective cure rate, improvement and failure rate, the incidence of complications such as obstruction, voiding difficulties, hemorrhage etc. Patients will be asked to complete preoperatively and postoperatively the ICIQ-FLUTS, patient satisfaction questionnaire and the female sexual function index.postoperatively the patients will complete the PGI-I questionnaire.

Official Title
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Prospective Randomized Trial of Altis Minisling With the TVTO Transobturator Tape Procedure for the Management of Genuine Stress Urinaty Incontinence in Women

Conditions
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Genuine Stress Incontinence

Intervention / Treatment
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* Procedure: Altis tape
* Procedure: TVTO


Participation Criteria
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Eligibility Criteria
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Inclusin Criteria: Having genuine stress urinary incontinence proven by urodynamics be willing to be operated and participate in the study. Exclusion Criteria: History of previous irradiation in the lower genital tract BMI more than 30kg/m2 previous anti-incontinence surgery, previous vaginal surgery having MUCP< 30 cm H2O or Valsava leak point pressure less than than 60 cm H2O Mixed urinary incontinence.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomised
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A<br>Altis tape surgical placement | Procedure: Altis tape<br>* placement of Altis tape through transobturator foramen bilaterally under epidural anesthesia<br>|
| Placebo Comparator: group B<br>TVT transobturator tape placement | Procedure: TVTO<br>* placement of TVTO tape through transobturator foarmen bilaterally under epidural anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the objective urinary continence rate at 12 months | Primary outcome measure will be the objective urinary continence rate at 12 months as it is assessed with cough stress test during urodynamics. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective urinary continence rate at 12 months follow up | Secondary outcome measure will be the subjective continence rate as it is assessed with the use of the PGI-I questionnaire. | 1year | 
| Preoperative and postoperative assessment of sexual function | Patients will be asked to complete preoperatively and postoperatively the female sexual function index. Minimum score 2.0 and maximum score 36.0. Higher values represent a better outcome. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress incontinence, female, altis, transobturator tape, minisling