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IUL Study A Randomized Sham - Controlled Clinical Study

NCT04707690 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-01-18

No results posted yet for this study

Summary

Primary aim of the study is to compare the impact of SUI on the VAS (visual analogue scale) 3 months after laser therapy versus sham laser therapy.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Intraurethral laser therapy

The laser will be applied according to the manufacturer's protocol. This includes a 2 step laser treatment using 2 different modes at 2 timepoints. The treatment takes about 15 minutes time.

DEVICE

Intraurethral SHAM laser therapy

The laser will be applied according to the manufacturer's protocol. This includes a 2 step laser treatment using 2 different modes at 2 timepoints. The treatment takes about 15 minutes time.

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-01-08
Primary Completion
2025-01-01
Completion
2025-01-01

Countries

  • Austria

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 NCT04707690 on ClinicalTrials.gov