Status:
COMPLETED
Combined Non-ablative Er:YAG Laser and Magnetic Stimulation for Treatment of Female Urinary Incontinence
Lead Sponsor:
Zdravstveni Zavod Štrumbelj
Collaborating Sponsors:
Fotona d.o.o.
Conditions:
Stress Urinary Incontinence
Urinary Incontinence
Eligibility:
FEMALE
18-80 years
Phase:
NA
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) t...
Detailed Description
The aim of this single-centre, single-arm pilot study is to investigate the combined effects of vaginal Er:YAG laser and HITS treatment on urinary incontinence (UI) in women. The study will involve 25...
Eligibility Criteria
Inclusion
- Adult female, 18 years of age or older
- Clinical diagnosis of stress or mixed urinary incontinence, with stress incontinence as the predominant symptom
Exclusion
- 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
Key Trial Info
Start Date :
April 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06559423
Start Date
April 23 2021
End Date
October 21 2022
Last Update
August 19 2024
Active Locations (1)
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1
Zdravstveni Zavod Štrumbelj
Ljubljana, Slovenia, 1000