Laser and High Intensity Tesla Magnetic Stimulation (HITS) for Stress Urinary Incontinence (SUI)
NCT ID: NCT05670392
Last Updated: 2023-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2023-02-01
2025-01-31
Brief Summary
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Detailed Description
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The efficacy and safety of combined treatment with non-ablative intravaginal Er:YAG laser procedure and high intensity Tesla magnetic stimulation will be compared to the treatment of non-ablative intravaginal Er:YAG laser alone.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: laser and HITS treatment
Laser and magnetic chair Treatment
laser and High intensity Tesla magnetic stimulation
Three (3) non-ablative Er:YAG laser treatments will be applied at monthly intervals followed by Eight (8) HITS therapies) Patients will receive two (2) HITS treatments per week for four (4) weeks(.
Arm 2: laser (without HITS treatment)
Laser treatment
laser (without HITS treatment)
Three (3) non-ablative Er:YAG laser treatments will be applied at monthly intervals as described above.
Interventions
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laser and High intensity Tesla magnetic stimulation
Three (3) non-ablative Er:YAG laser treatments will be applied at monthly intervals followed by Eight (8) HITS therapies) Patients will receive two (2) HITS treatments per week for four (4) weeks(.
laser (without HITS treatment)
Three (3) non-ablative Er:YAG laser treatments will be applied at monthly intervals as described above.
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of stress or mixed urinary incontinence, with stress incontinence as the predominant symptom (SUI or MUI)
Exclusion Criteria
2. Pregnancy
3. BMI\>35
4. Acute urinary tract infections (UTIs)
5. 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)
6. Active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infection
7. Prolapse grade 2 or higher
8. History of radiotherapy for cervical or uterine cancer
9. Medical condition that may interfere with participants' compliance to the protocol
10. Medical condition for which the HITS and laser therapy are contraindicated
11. Previous laser or HITS treatment for SUI
18 Years
FEMALE
Yes
Sponsors
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Fotona d.o.o.
INDUSTRY
Cork University Maternity Hospital
OTHER
Responsible Party
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Barry O'Reilly
Head of Urogynecology department
Principal Investigators
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Barry O'Reilly, Prof.
Role: PRINCIPAL_INVESTIGATOR
Cork University Maternity Hospital
Central Contacts
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References
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Kuszka A, Gamper M, Walser C, Kociszewski J, Viereck V. Erbium:YAG laser treatment of female stress urinary incontinence: midterm data. Int Urogynecol J. 2020 Sep;31(9):1859-1866. doi: 10.1007/s00192-019-04148-9. Epub 2019 Dec 11.
Chandi DD, Groenendijk PM, Venema PL. Functional extracorporeal magnetic stimulation as a treatment for female urinary incontinence: 'the chair'. BJU Int. 2004 Mar;93(4):539-42. doi: 10.1111/j.1464-410x.2003.04659.x.
Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005654. doi: 10.1002/14651858.CD005654.pub4.
He Q, Xiao K, Peng L, Lai J, Li H, Luo D, Wang K. An Effective Meta-analysis of Magnetic Stimulation Therapy for Urinary Incontinence. Sci Rep. 2019 Jun 24;9(1):9077. doi: 10.1038/s41598-019-45330-9.
Other Identifiers
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LASERHITS
Identifier Type: -
Identifier Source: org_study_id
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