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

NCT03515109 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-05-03

No results posted yet for this study

Summary

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

Conditions

  • Genuine Stress Incontinence

Interventions

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

Sponsors & Collaborators

  • Aretaieio Hospital

    lead OTHER

Principal Investigators

  • PANAGIOTIS VAKAS · aretaieio university hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-25
Primary Completion
2018-03-25
Completion
2018-11-25
FDA Device
Yes

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03515109 on ClinicalTrials.gov