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Long-term Effectiveness of Non-ablative Er: YAG Laser for Treatment of Stress Urinary Incontinence (SUI)

NCT04348994 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2020-04-17

No results posted yet for this study

Summary

Study is designed to assess the long-term clinical effects and safety profile of non-ablative Er:YAG (IncontiLase®) laser treatment, the durability of the results and the optimal treatment regimen for mild-to-severe stages of genuine female stress urinary incontinence (SUI).

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Non-ablative thermal-only Er:YAG laser therapy

Each patient will receive 3 sessions of Er:YAG laser treatment for SUI (IncontiLase®). Single-session treatments will be offered to patients after 18, 24 and 30 months following the initial three sessions.

Sponsors & Collaborators

  • Fotona d.o.o.

    collaborator INDUSTRY

  • Adrian Gaspar

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-01
Primary Completion
2018-09-01
Completion
2018-12-31

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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 NCT04348994 on ClinicalTrials.gov