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Combined Non-ablative Er:YAG Laser and Magnetic Stimulation for Treatment of Female Urinary Incontinence

NCT06559423 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-08-19

No results posted yet for this study

Summary

This single-arm pilot study aims to investigate the efficacy and safety of a combined non-ablative Erbium:Yttrium-Aluminium-Garnet (Er:YAG) laser and High Intensity Tesla magnetic Stimulation (HITS) treatment for female urinary incontinence. The study involves 25 women diagnosed with mild to moderate stress or mixed urinary incontinence. Participants will receive three vaginal Er:YAG laser treatments and six HITS sessions. The primary objective is to improve symptoms of urinary incontinence, as measured by changes in scores on two questionnaires compared to baseline. Secondary objectives include improvement in sexual function, durability of improvement in urinary incontinence symptoms at 3- and 6- month follow-up, patient-reported improvement, and discomfort during treatment.

Conditions

Interventions

DEVICE

non-ablative Er:YAG laser and high intensity Tesla magnetic stimulation (HITS)

Patients will initially undergo three monthly intravaginal treatments with the Er:YAG laser. Six weeks after the final laser treatment, patients will receive six sessions of magnetic stimulation. During these sessions, patients will sit on a specialized chair that generates a therapeutic magnetic field.

Sponsors & Collaborators

  • Fotona d.o.o.

    collaborator INDUSTRY

  • Zdravstveni Zavod Štrumbelj

    lead OTHER

Principal Investigators

  • Tadeja Štrumbelj, MD · Zdravstveni Zavod Štrumbelj

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-04-23
Primary Completion
2022-10-21
Completion
2022-10-21

Countries

  • Slovenia

Study Locations

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Entities

Diseases

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 NCT06559423 on ClinicalTrials.gov