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

NCT ID: NCT03098992

Last Updated: 2019-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2020-06-30

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fotona Dynamis Er:YAG Laser System

Active treatment with Fotona Dynamis Er:YAG Laser System

Group Type: ACTIVE_COMPARATOR

Fotona Dynamis Er:YAG Laser System

Intervention Type: DEVICE

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

Group Type: SHAM_COMPARATOR

Fotona Dynamis Er:YAG Laser System with sham handpience

Intervention Type: DEVICE

Sham treatment with a sham handpiece and parameter presentations masked

Interventions

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

Intervention Type: DEVICE

Fotona Dynamis Er:YAG Laser System with sham handpience

Sham treatment with a sham handpiece and parameter presentations masked

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fotona d.o.o.

INDUSTRY

Sponsor Role: collaborator

Cork University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Barry O'Reilly

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barry O'Reilly, Professor

Role: PRINCIPAL_INVESTIGATOR

University College Cork

Locations

Lutheran Hospital Hagen-Haspe

Hagen, , Germany

University of Athens, Alexandra Hospital

Athens, , Greece

Cork Womens Clinic

Cork, , Ireland

University Clinical Centre

Ljubljana, , Slovenia

Inselspital Bern, University Hospital

Bern, , Switzerland

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

Countries

Germany; Greece; Ireland; Slovenia; Switzerland; United Kingdom

References

Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.

Reference Type: DERIVED

PMID: 40709601 (View on PubMed)

Other Identifiers

FOTONA-Incontilase

Identifier Type: -

Identifier Source: org_study_id