The Efficacy and Safety of Fotona Smooth® Device for the Treatment of Stress Urinary Incontinence
- Conditions
- Stress Urinary Incontinence
- Registration Number
- NCT03098992
- Lead Sponsor
- Cork University Hospital
- Brief 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
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 135
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety: Incidence and severity of device related Adverse Events 6 months post-treatment Incidence and severity of device related Adverse Events (i.e., infections, edema, superficial burns, increased vaginal discharge, de novo urge incontinence).
Efficacy: Reduction in 1-hour pad weight between active and sham groups 6 months post-treatment Reduction in 1-hour pad weight at 6 months post-treatment in active group vs the sham treated group at 6 months post treatment
- Secondary Outcome Measures
Name Time Method Change in mean PISQ-12 test scores from baseline to 6 and 12 months post-treatment. Change in mean PISQ-12 test scores from baseline to 6 and 12 months post-treatment.
Durability of the effect 12 months post-treatment Reduction in 1hr pad test weight in the treated group at 12 month follow-up vs. pad weight in the same group at baseline
Change in King's Health Questionnaire (KHQ) from baseline to 6 and 12 months post-treatment. Change in mean KHQ from baseline to 6 and 12 months post-treatment
Subjective assessment of pain 6 months Patient reported assessment of pain during treatment
Improvement 6 and 12 months post-treatment Change in mean Cough Stress test score at 6 and 12 months post-treatment
Change in International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) score from baseline to 6 and 12 months post-treatment. Change in mean ICIQ-SF from baseline to 6 and 12 months post-treatment
Trial Locations
- Locations (9)
Cork Womens Clinic
🇮🇪Cork, Ireland
Cantonal Hospital Frauenfeld
🇨🇭Frauenfeld, Switzerland
Basingstoke and North Hampshire Hospital
🇬🇧Basingstoke, United Kingdom
Birmingham Women's Hospital NHS foundation trust
🇬🇧Birmingham, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
University Clinical Centre
🇸🇮Ljubljana, Slovenia
University of Athens, Alexandra Hospital
🇬🇷Athens, Greece
Lutheran Hospital Hagen-Haspe
🇩🇪Hagen, Germany
Inselspital Bern, University Hospital
🇨🇭Bern, Switzerland