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Search / Trial NCT03515109

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

Launched by ARETAIEIO HOSPITAL · Apr 22, 2018

Trial Information

Current as of May 03, 2025

Unknown status

Keywords

Stress Incontinence Female Altis Transobturator Tape Minisling

ClinConnect Summary

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.previou...

Gender

FEMALE

Eligibility 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.

About Aretaieio Hospital

Aretaieio Hospital is a leading healthcare institution dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a commitment to excellence in patient care and a focus on evidence-based practices, the hospital collaborates with multidisciplinary teams to conduct rigorous studies across various therapeutic areas. Aretaieio Hospital prioritizes patient safety and ethical standards, ensuring that all clinical trials adhere to regulatory guidelines while fostering an environment of scientific inquiry and collaboration. Through these efforts, the hospital aims to contribute significantly to the body of medical knowledge and enhance treatment options for patients.

Locations

Athens, Attiki, Greece

Patients applied

0 patients applied

Trial Officials

PANAGIOTIS VAKAS

Principal Investigator

aretaieio university hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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