Laser and High Intensity Tesla Magnetic Stimulation (HITS) for Stress Urinary Incontinence (SUI)

Study Overview
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Brief Summary
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To investigate the efficacy of combined laser and HITS treatment for female stress urinary incontinence (SUI)

Detailed Description
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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.

Official Title
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The Advantage of Combined Non-ablative Erbium Yttrium Aluminum Garnet Laser and High Intensity Tesla Magnetic Stimulation for Treatment of Female Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: laser and High intensity Tesla magnetic stimulation
* Device: laser (without HITS treatment)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult female, 18 years of age or older Clinical diagnosis of stress or mixed urinary incontinence, with stress incontinence as the predominant symptom (SUI or MUI) Exclusion Criteria: 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) Pregnancy BMI>35 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 SUI

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a two-arm parallel assignment, randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1: laser and HITS treatment<br>Laser and magnetic chair Treatment | Device: laser and High intensity Tesla magnetic stimulation<br>* 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(.<br>|
| Other: Arm 2: laser (without HITS treatment)<br>Laser treatment | Device: laser (without HITS treatment)<br>* Three (3) non-ablative Er:YAG laser treatments will be applied at monthly intervals as described above.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of stress urinary incontinence | Change of symptoms of stress and/or mixed urinary incontinence as measured by change in one hour pad test (gr/h) results at the end of treatment period from the baseline results. | measured at 3 and 6 months | 
| Adverse events | The number and severity of treatment-related Adverse Events. | up to 6 month post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QUID - Questionnaire for Urinary Incontinence Diagnosis | The Questionnaire for Urinary Incontinence Diagnosis (QUID) identifies the presence and frequency of stress and urge incontinence symptoms. Three items focus on stress incontinence symptoms and three on urge incontinence symptoms. Each item includes 6 frequency-based response options, ranging from none of the time to all of the time, which are scored from 0 to 5 points. Scores are calculated in an additive fashion, resulting in separate Stress and Urge scores, each ranging from 0 to 15 points. | measured at 3 and 6 months | 
| FSFI - The Female Sexual Function Index | FSFI - The Female Sexual Function Index is a generalized questionnaire utilized to assess sexual function in women in a general population. It has been validated on clinically diagnosed samples of women with female sexual arousal disorder, female orgasmic disorder, and hypoactive sexual desire disorder. Scoring is between 2 (low sexual function)-36 (high sexual function). | measured at 3 and 6 months | 
| PGI-I - Patient Global Impression of Improvement | The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians. 1-7: Very much better- 1, Much better -2, A little better-3, No change-4, A little worse-5, Much worse-6, Very much worse-7. | measured at 3 and 6 months | 
| One-hour pad test. | he testing protocol has been standardized by International Continence Society (ICS-pad test): the test is started by putting one pre-weighted pad without patient voiding, patient drinks 500 ml of sodium-free liquid in <15 min- then sits or rests, patient walks for 30 min, including climbing one flight of stairs (up and down), patient performs the following activities: standing up from sitting (10x), coughing vigorously (10x), running on the spot for 1 min, bending to pick up an object from the floor (5x), and washing hands in running water for 1min (this activity program may be modified according to the patient's physical fitness), the total amount of urine leaked is determined by weighing the pad. If a moderately full bladder cannot be maintained through the hour (if the patient must void), the test has to be started again. | measured at 3 and 6 months | 
| International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) | The ICIQ-UI Short Form is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world. This short and simple questionnaire is also of use to general practitioners and clinicians in both primary and secondary care institutions to screen for incontinence, to obtain a brief yet comprehensive summary of the level, impact and perceived cause of symptoms of incontinence and to facilitate patient-clinician discussions. Scoring is between 0 to 21 (worse symptoms ) | measured at 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SUI, Incontinence, Laser, High Intensity Tesla Magnetic Stimulation