The Efficacy and Safety of Fotona Smooth® Device for the Treatment of Stress Urinary Incontinence

Study Overview
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Brief Summary
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There are many existing treatments of female stress urinary incontinence such as the use of adult absorbent pads and diapers, behavioral training, including bladder training, pelvic muscle exercises, biofeedback, urethral plugs, intravaginal prosthesis, electrical stimulation, periurethral injections, and reconstructive surgery. However, there is still a lack of effective minimally invasive treatment options that are independent of patient compliance. One emerging approach of minimally invasive SUI therapy is pelvic floor reinforcement using laser therapy. The primary objective of this post-marketing study is to confirm the effectiveness and safety of the FotonaSmooth® device in the treatment of stress urinary incontinence (SUI) in a large number of females using objective and subjective methods. Patients with stress incontinence will be assigned to two groups, an active group, where the Fotona Dynamis Er:YAG Laser System will be used, and a sham group where a very low laser setting will be used, and parameter presentations will be masked. Participants will be adult females, 18 years old and older with clinical and urodynamic diagnosis of Stress Urinary Incontinence,who have had no significant improvement in urinary incontinence from at least one previous conservative treatment, such as behavioral measures, pelvic floor muscle training or the use of absorbent pads

Detailed Description
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Prospective, randomized, 2-treatment, sham-controlled, single (patient only) blinded, study design using convenience sampling to enroll subjects as they present and are found to be eligible per the inclusion/exclusion criteria. This multicenter clinical trial utilizes a randomized assignment allocation schedule stratified by clinical site. Allocation rule pertains to the ratio of subjects in each treatment arm. Sampling rules pertain to the number of subjects in each active treatment arm. Two treatment arms enrolled on a 2:1 ratio: Active arm is the Fotona Dynamis Er:YAG Laser System and the control arm is a sham treatment with a very low laser setting and parameter presentations masked. The active arm subjects will be followed out to 12 months post-treatment. The sham arm subjects will be followed out to 6 months and then offered the active treatment.

Official Title
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Post-market, Prospective, Randomised, Sham-controlled Clinical Trial Designed to Confirm the Efficacy and Safety of the Fotona Smooth® Device to Treat Female Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Fotona Dynamis Er:YAG Laser System
* Device: Fotona Dynamis Er:YAG Laser System with sham handpience


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Female, 18 years of age or older, Clinical and UDS diagnosis of Stress Urinary Incontinence, No significant improvement in urinary incontinence from at least one previous conservative treatments, such as behavioral measures, pelvic floor muscle training or the use of absorbent pads Exclusion Criteria: Pre-existing bladder pathology including prior radiation treatment Pregnancy BMI>35 Radical pelvic surgery or previous incontinence surgery Urinary tract infection or other active infections of urinary tract or bladder Endometriosis Any form of pelvic organ prolapse greater than stage 2, according to POP-Q Diagnosis of urge incontinence Diagnosis of collagen disorders e.g. benign joint hypermobility / Elhers-Danlos / Marfans etc. Incomplete bladder emptying Vesicovaginal fistula Fecal incontinence Unwillingness or inability to complete follow-up schedule Unwillingness or inability to give Informed Consent Failure to comply with diary requirements during extended baseline period

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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No

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fotona Dynamis Er:YAG Laser System<br>Active treatment with Fotona Dynamis Er:YAG Laser System | Device: Fotona Dynamis Er:YAG Laser System<br>* Treatment of urodynamic proven stress urinary incontinence using the Fotona Dynamis Er:YAG Laser System in the active arm<br>|
| Sham Comparator: Fotona Dynamis Er:YAG Laser System with Sham handpience<br>Sham treatment with a sham handpiece and parameter presentations masked | Device: Fotona Dynamis Er:YAG Laser System with sham handpience<br>* Sham treatment with a sham handpiece and parameter presentations masked<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Reduction in 1-hour pad weight between active and sham groups | Reduction in 1-hour pad weight at 6 months post-treatment in active group vs the sham treated group at 6 months post treatment | 6 months post-treatment | 
| Safety: Incidence and severity of device related Adverse Events | Incidence and severity of device related Adverse Events (i.e., infections, edema, superficial burns, increased vaginal discharge, de novo urge incontinence). | 6 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Durability of the effect | Reduction in 1hr pad test weight in the treated group at 12 month follow-up vs. pad weight in the same group at baseline | 12 months post-treatment | 
| Improvement | Change in mean Cough Stress test score at 6 and 12 months post-treatment | 6 and 12 months post-treatment | 
| Change in King's Health Questionnaire (KHQ) | Change in mean KHQ from baseline to 6 and 12 months post-treatment | from baseline to 6 and 12 months post-treatment. | 
| Change in mean PISQ-12 test scores | Change in mean PISQ-12 test scores from baseline to 6 and 12 months post-treatment. | from baseline to 6 and 12 months post-treatment. | 
| Subjective assessment of pain | Patient reported assessment of pain during treatment | 6 months | 
| Change in International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) score | Change in mean ICIQ-SF from baseline to 6 and 12 months post-treatment | from baseline to 6 and 12 months post-treatment. |