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

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

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

Study Overview

• Status: Unknown
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Fotona Dynamis Er:YAG Laser System; Device: Fotona Dynamis Er:YAG Laser System with sham handpience

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hagen, Germany
    • Lutheran Hospital Hagen-Haspe
• Greece
  • Athens, Greece
    • University of Athens, Alexandra Hospital
• Ireland
  • Cork, Ireland
    • Cork Womens Clinic
• Slovenia
  • Ljubljana, Slovenia
    • University Clinical Centre
• Switzerland
  • Bern, Switzerland
    • Inselspital Bern, University Hospital
  • Frauenfeld, Switzerland
    • Cantonal Hospital Frauenfeld
• United Kingdom
  • Basingstoke, United Kingdom
    • Basingstoke and North Hampshire Hospital
  • Birmingham, United Kingdom
    • Birmingham Women's Hospital NHS Foundation Trust
  • London, United Kingdom
    • King's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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:

1. Pre-existing bladder pathology including prior radiation treatment
2. Pregnancy
3. BMI>35
4. Radical pelvic surgery or previous incontinence surgery
5. Urinary tract infection or other active infections of urinary tract or bladder
6. Endometriosis
7. Any form of pelvic organ prolapse greater than stage 2, according to POP-Q
8. Diagnosis of urge incontinence
9. Diagnosis of collagen disorders e.g. benign joint hypermobility / Elhers-Danlos / Marfans etc.
10. Incomplete bladder emptying
11. Vesicovaginal fistula
12. Fecal incontinence
13. Unwillingness or inability to complete follow-up schedule
14. Unwillingness or inability to give Informed Consent
15. Failure to comply with diary requirements during extended baseline period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Cork University Hospital
• Collaborators: Fotona d.o.o.
• Investigators: Principal Investigator: Barry O'Reilly, Professor, University College Cork

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 11, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: FOTONA-Incontilase

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No