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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03098992
• Other study ID #: FOTONA-Incontilase
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2019
• Source: Cork University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 135
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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
• Fotona Dynamis Er:YAG Laser System with sham handpience
Sham treatment with a sham handpiece and parameter presentations masked

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Cork University Hospital	Fotona d.o.o.

Countries where clinical trial is conducted

Germany,  Greece,  Ireland,  Slovenia,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Improvement	Change in mean Cough Stress test score at 6 and 12 months post-treatment	6 and 12 months post-treatment
Secondary	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.
Secondary	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.
Secondary	Subjective assessment of pain	Patient reported assessment of pain during treatment	6 months
Secondary	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.