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

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

Genuine Stress Incontinence

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.

Altis tape

TVTO

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

Primary outcome measure will be the objective urinary continence rate at 12 months as it is assessed with cough stress test during urodynamics.

Associate Professor Obstetrics and Gynecology

Secondary outcome measure will be the subjective continence rate as it is assessed with the use of the PGI-I questionnaire.

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.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the Participation Requirements?