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

NCT03098992 | Unknown

• 1 other identifier: FOTONA-Incontilase
• Study Type: interventional
• Target: 135
• Locations: 6 countries
• Sites: 9

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

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Durability of the effect

  12 months post-treatment

• Improvement

  6 and 12 months post-treatment

• Change in King's Health Questionnaire (KHQ)

  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.

• Subjective assessment of pain

  6 months

Study Arms (2)

Fotona Dynamis Er:YAG Laser System

ACTIVE COMPARATOR

Active treatment with Fotona Dynamis Er:YAG Laser System

Device: Fotona Dynamis Er:YAG Laser System

Fotona Dynamis Er:YAG Laser System with Sham handpience

SHAM COMPARATOR

Sham treatment with a sham handpiece and parameter presentations masked

Device: Fotona Dynamis Er:YAG Laser System with sham handpience

Interventions

Fotona Dynamis Er:YAG Laser System 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

Fotona Dynamis Er:YAG Laser System with sham handpience DEVICE

Sham treatment with a sham handpiece and parameter presentations masked

Fotona Dynamis Er:YAG Laser System with Sham handpience

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cork University Hospital: lead
• Fotona d.o.o.: collaborator

Study Sites (9)

Lutheran Hospital Hagen-Haspe

Hagen, Germany

Location

University of Athens, Alexandra Hospital

Athens, Greece

Location

Cork Womens Clinic

Cork, Ireland

Location

University Clinical Centre

Ljubljana, Slovenia

Location

Inselspital Bern, University Hospital

Bern, Switzerland

Location

Cantonal Hospital Frauenfeld

Frauenfeld, Switzerland

Location

Basingstoke and North Hampshire Hospital

Basingstoke, United Kingdom

Location

Birmingham Women's Hospital NHS foundation trust

Birmingham, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40709601 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barry O'Reilly, Professor

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: April 4, 2017
• Study Start: June 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2020
• Last Updated: June 12, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); CH (2); GB (3); SL (1); DE (1); IE (1)