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

NCT06559423 | Completed

• 1 other identifier: Study Laser + HITS
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Stress Urinary Incontinence; Urinary Incontinence

Keywords

stress urinary incontinence; urinary incontinence; non-ablative erbium laser; magnetic stimulation; High Intensity Tesla magnetic Stimulation (HITS); combined therapy; Er:YAG laser

Outcome Measures

Primary Outcomes (2)

• Efficacy of the combined laser and HITS treatment

  Improvement of symptoms of stress and/or mixed urinary incontinence as measured by change in ICIQ-UI SF and QUID scores from the baseline.

  up to 6 months after treatment

• Safety of the combined laser and HITS treatment

  Incidence and severity of treatment-related Adverse Events

  up to 6 months after treatment

Secondary Outcomes (4)

• Improvement of sexual function

  up to 6 months after treatment

• Durability of the effect

  up to 6 months after treatment

• Patient reported assessment of improvement

  up to 6 months after treatment

• Patient reported assessment of discomfort during treatment

  up to 24 hours after each laser and HITS session

Study Arms (1)

Laser + HITS

EXPERIMENTAL

The treatment involved three consecutive Er:YAG laser sessions (TimeWalker® Intima Laser™, Fotona) followed by six HITS treatments (StarFormer® IntimaWave®, Fotona). The laser sessions were spaced one month apart, following the IncontiLase® protocol using the G-Runner robotic handpiece. The protocol included three steps: (i) intravaginal laser treatment of the anterior vaginal wall, (ii) treatment of the entire vaginal canal, and (iii) treatment of the vestibule and introitus. Each session lasted 20 minutes. Six weeks after the final laser treatment, patients received six HITS treatments, with two sessions per week. The HITS protocol involved increasing stimulation frequencies, each for 10 minutes, with the total session lasting 30 minutes.

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

Interventions

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

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.

Laser + HITS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult female, 18 years of age or older
• Clinical diagnosis of stress or mixed urinary incontinence, with stress incontinence as the predominant symptom

You may not qualify if:

• Very severe urinary incontinence (ICIQ-UI SF score at baseline \>18)
• Pregnancy
• BMI\>35
• Not willing to abstain from vaginal intercourse for one week following the laser-therapy
• Acute urinary tract infections (UTIs)
• History of a genital fistula, a thin recto-vaginal septum as determined by the investigator or history of a fourth-degree laceration during screening physical exam (e.g., perineal body)
• Active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infection
• Prolapse grade 2 or higher
• History of radiotherapy for cervical or uterine cancer
• Medical condition that may interfere with participants' compliance to the protocol
• Medical condition for which the HITS and laser therapy are contraindicated
• Previous laser or HITS treatment for UI

Sponsors & Collaborators

• Zdravstveni Zavod Štrumbelj: lead
• Fotona d.o.o.: collaborator

Study Sites (1)

Zdravstveni Zavod Štrumbelj

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tadeja Štrumbelj, MD

  Zdravstveni Zavod Štrumbelj

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 19, 2024
• Study Start: April 23, 2021
• Primary Completion: October 21, 2022
• Study Completion: October 21, 2022
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)