NCT03515109

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Aretaieio Hospital · Academic / Other
• Sex: Female
• Age: 25 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Genuine Stress Incontinence

Interventions

Type	Name	Description
PROCEDURE	Altis tape	placement of Altis tape through transobturator foramen bilaterally under epidural anesthesia
PROCEDURE	TVTO	placement of TVTO tape through transobturator foarmen bilaterally under epidural anesthesia

Timeline

• Start date: 2017-11-25
• Primary completion: 2018-03-25
• Completion: 2018-11-25
• First posted: 2018-05-03
• Last updated: 2018-05-03

Locations

1 site across 1 country: Greece

Regulatory

• FDA-regulated device study