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

Aretaieio Hospital

Status: Unknown

Conditions: Genuine Stress Incontinence

Treatments: Procedure: Altis tape; Procedure: TVTO

Study type: Interventional

Funder types: Other

Identifiers

NCT03515109

0001

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 25 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

group A

Active Comparator group

Description:

Altis tape surgical placement

Treatment:

Procedure: Altis tape

group B

Placebo Comparator group

Description:

TVT transobturator tape placement

Treatment:

Procedure: TVTO