Laser Treatment for Stress Incontinence
Research type
Research Study
Full title
Prospective, Randomised, Controlled Clinical Trial Designed to Confirm the Efficacy and Safety of the Fotona Smooth(R) Device to Treat Female Stress Urinary Incontinence
IRAS ID
190876
Contact name
Christian Phillips
Contact email
Sponsor organisation
FOTONA d.o.o.
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Stress urinary incontinence (SUI) is an involuntary loss of urine during coughing/ exertion. It is caused by injury to the pelvic floor muscles or the collagen (fascia) underlying the bladder and urethra. One emerging approach to treat SUI is laser therapy. Laser therapy has been proven to be successful in treating disorders affected by collagen damage. The Er-Yag laser by Fotona is a non-ablative laser therapy that promotes collagen synthesis in the tissues around the bladder outlet. It has been used in numerous post marketing studies in almost 1000 patients. These have already demonstrated an excellent safety record along with an improvement in the connective tissue of the endopelvic fascia as well as improvement in SUI symptoms in women with SUI.
The primary objective of this study is to confirm in a randomised controlled trial the effectiveness and safety of the FotonaSmooth® device in the treatment of SUI in 120 women.
This study is a prospective, randomized, patient blinded study comparing Erbium Yag laser therapy versus a sham control in women with proven SUI that has not responded to pelvic floor exercises.
The two treatment arms will be enrolled on a 2:1 ratio. The active arm receive Er:YAG Laser ; the control arm is a sham treatment. 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.
Each subject will receive two treatments with 30 days between the first and second treatments. The primary endpoints of this study are:
Efficacy: Reduction in 1-hour pad weight at 6 months post-treatment in active group vs the sham treated group at 6 months post treatment.
Safety: Incidence and severity of device related Adverse Events.
120 subjects will be enrolled from European sites to ultimately attain 104 evaluable subjects.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
16/EM/0099
Date of REC Opinion
6 Apr 2016
REC opinion
Further Information Favourable Opinion