Clinical trial NCT05670392: Laser and High Intensity Tesla Magnetic Stimulation (HITS) for Stress Urinary Incontinence (SUI)
Official title: The Advantage of Combined Non-ablative Erbium Yttrium Aluminum Garnet Laser and High Intensity Tesla Magnetic Stimulation for Treatment of Female Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: SUI
Incontinence
Laser
High Intensity Tesla Magnetic Stimulation
Lead sponsor: Cork University Maternity Hospital
Sponsor class: OTHER
Collaborators: name: Fotona d.o.o.
First posted: 2023-01-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a two-arm parallel assignment, randomized control trial
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy of combined laser and HITS treatment for female stress urinary incontinence (SUI)

Detailed description: This study is a single-centre, two-arm randomized control trial study conducted according to Helsinki Declaration. Women with symptoms of stress urinary incontinence (SUI) (stress or mixed with stress incontinence as the predominant symptom) will be enrolled.

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.

Eligibility criteria: Inclusion Criteria:

1. Adult female, 18 years of age or older
2. Clinical diagnosis of stress or mixed urinary incontinence, with stress incontinence as the predominant symptom (SUI or MUI)

Exclusion Criteria:

1. Very severe urinary incontinence (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) ICIQ-UI )score at baseline \>18 or Pad test \> 50 gr)
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

Primary outcomes:
measure: Symptoms of stress urinary incontinence
timeFrame: measured at 3 and 6 months
measure: Adverse events
timeFrame: up to 6 month post procedure
Secondary outcomes:
measure: QUID - Questionnaire for Urinary Incontinence Diagnosis
timeFrame: measured at 3 and 6 months
measure: FSFI - The Female Sexual Function Index
timeFrame: measured at 3 and 6 months
measure: PGI-I - Patient Global Impression of Improvement
timeFrame: measured at 3 and 6 months
measure: One-hour pad test.
timeFrame: measured at 3 and 6 months
measure: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
timeFrame: measured at 3 and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Cork University Maternity Hospital
name: Barry O'Reilly, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.