Clinical trial NCT03098992: The Efficacy and Safety of Fotona Smooth® Device for the Treatment of Stress Urinary Incontinence
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Cork University Hospital
Sponsor class: OTHER
Collaborators: name: Fotona d.o.o.
First posted: 2017-04-04
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy: Reduction in 1-hour pad weight between active and sham groups
timeFrame: 6 months post-treatment
measure: Safety: Incidence and severity of device related Adverse Events
timeFrame: 6 months post-treatment
Secondary outcomes:
measure: Durability of the effect
timeFrame: 12 months post-treatment
measure: Improvement
timeFrame: 6 and 12 months post-treatment
measure: Change in King's Health Questionnaire (KHQ)
timeFrame: from baseline to 6 and 12 months post-treatment.
measure: Change in mean PISQ-12 test scores
timeFrame: from baseline to 6 and 12 months post-treatment.
measure: Subjective assessment of pain
timeFrame: 6 months
measure: Change in International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) score
timeFrame: from baseline to 6 and 12 months post-treatment.
Other outcomes:
Locations:
city: Hagen
country: Germany
facility: Lutheran Hospital Hagen-Haspe
city: Athens
country: Greece
facility: University of Athens, Alexandra Hospital
city: Cork
country: Ireland
facility: Cork Womens Clinic
city: Ljubljana
country: Slovenia
facility: University Clinical Centre
city: Bern
country: Switzerland
facility: Inselspital Bern, University Hospital
city: Frauenfeld
country: Switzerland
facility: Cantonal Hospital Frauenfeld
city: Basingstoke
country: United Kingdom
facility: Basingstoke and North Hampshire Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Women's Hospital NHS foundation trust
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: University College Cork
name: Barry O'Reilly, Professor
role: PRINCIPAL_INVESTIGATOR
References: