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Intraurethral/Intravaginal 2940 Nm Erbium Laser Treatment for Stress Urinary Incontinence

NCT03676894 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-03-13

No results posted yet for this study

Summary

Primary objective is to assess the tolerability and safety of the intraurethral 2940nm Er:YAG laser technique in combination with intravaginal 2940nm Er:YAG laser method for the treatment of stress urinary incontinence.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Sham Fotona SP Dynamis

Female patients with SUI will be treated with non-ablative Er:YAG laser with Fotona SP Dynamis with sham handpiece.

DEVICE

Intravaginal Fotona SP Dynamis

Female patients with SUI will be treated intravaginaly with non-ablative Er:YAG laser with Fotona SP Dynamis

DEVICE

Intraurethral Fotona SP Dynamis

Female patients with SUI will be treated intraurethraly with non-ablative Er:YAG laser with Fotona SP Dynamis

Sponsors & Collaborators

  • Fotona d.o.o.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-04
Primary Completion
2022-11-28
Completion
2023-05-23

Countries

  • Canada

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 NCT03676894 on ClinicalTrials.gov