Prospective Study of Altis System With the TVTO Procedure for the Management of Stress Urinary Incontinence in Women
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|ClinicalTrials.gov Identifier: NCT03515109|
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : May 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Genuine Stress Incontinence||Procedure: Altis tape Procedure: TVTO||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||prospective randomised|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||they will not be aware of the procedure they are going to perform or have.|
|Official Title:||Prospective Randomized Trial of Altis Minisling With the TVTO Transobturator Tape Procedure for the Management of Genuine Stress Urinaty Incontinence in Women|
|Actual Study Start Date :||November 25, 2017|
|Actual Primary Completion Date :||March 25, 2018|
|Estimated Study Completion Date :||November 25, 2018|
Active Comparator: group A
Altis tape surgical placement
Procedure: Altis tape
placement of Altis tape through transobturator foramen bilaterally under epidural anesthesia
Placebo Comparator: group B
TVT transobturator tape placement
placement of TVTO tape through transobturator foarmen bilaterally under epidural anesthesia
- the objective urinary continence rate at 12 months [ Time Frame: 1 year ]Primary outcome measure will be the objective urinary continence rate at 12 months as it is assessed with cough stress test during urodynamics.
- Subjective urinary continence rate at 12 months follow up [ Time Frame: 1year ]Secondary outcome measure will be the subjective continence rate as it is assessed with the use of the PGI-I questionnaire.
- Preoperative and postoperative assessment of sexual function [ Time Frame: 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515109
|Contact: PANAGIOTIS VAKAS||2107473204||P_BAKAS@YAHOO.COM|
|Contact: Emmanouil papadakis, Drfirstname.lastname@example.org|
|Aretaieio University Hospital||Recruiting|
|Athens, Attiki, Greece, 11528|
|Contact: PANAGIOTIS VAKAS 2107473204 P_BAKAS@YAHOO.COM|
|Principal Investigator:||PANAGIOTIS VAKAS||aretaieio university hospital|