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

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ClinicalTrials.gov Identifier: NCT03098992
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
FOTONA, D.O.O
Information provided by (Responsible Party):
Barry O'Reilly, 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


Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Device: Fotona Dynamis Er:YAG Laser System Device: Fotona Dynamis Er:YAG Laser System with sham handpience Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Fotona Dynamis Er:YAG Laser System
Active treatment with Fotona Dynamis Er:YAG Laser System
Device: 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

Sham Comparator: Fotona Dynamis Er:YAG Laser System with Sham handpience
Sham treatment with a sham handpiece and parameter presentations masked
Device: Fotona Dynamis Er:YAG Laser System with sham handpience
Sham treatment with a sham handpiece and parameter presentations masked




Primary Outcome Measures :
  1. Efficacy: Reduction in 1-hour pad weight between active and sham groups [ Time Frame: 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

  2. Safety: Incidence and severity of device related Adverse Events [ Time Frame: 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).


Secondary Outcome Measures :
  1. Durability of the effect [ Time Frame: 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

  2. Improvement [ Time Frame: 6 and 12 months post-treatment ]
    Change in mean Cough Stress test score at 6 and 12 months post-treatment

  3. Change in King's Health Questionnaire (KHQ) [ Time Frame: from baseline to 6 and 12 months post-treatment. ]
    Change in mean KHQ from baseline to 6 and 12 months post-treatment

  4. Change in mean PISQ-12 test scores [ Time Frame: 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.

  5. Subjective assessment of pain [ Time Frame: 6 months ]
    Patient reported assessment of pain during treatment

  6. Change in International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) score [ Time Frame: from baseline to 6 and 12 months post-treatment. ]
    Change in mean ICIQ-SF from baseline to 6 and 12 months post-treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098992


Contacts
Contact: Mateja Bozic mateja.bozic@fotona.com
Contact: Fadi Salameh +353838598814 salameh.fadi@gmail.com

Locations
Germany
Lutheran Hospital Hagen-Haspe Not yet recruiting
Hagen, Germany
Contact: Andrzej Kuszka, MD         
Greece
University of Athens Alexandra Hospital Recruiting
Athens, Greece
Contact: Stavros Athanasiou, MD         
Ireland
Cork Womens Clinic Recruiting
Cork, Ireland
Contact: Fadi Salameh       salameh.fadi@gmail.com   
Portugal
Hospital S. João Not yet recruiting
Porto, Portugal
Contact: Teresa Mascarenhas, MD         
Slovenia
University Clinical Centre Not yet recruiting
Ljubljana, Slovenia
Contact: Adolf Lukanovič, MD         
Switzerland
Inselspital Bern, University Hospital Not yet recruiting
Bern, Switzerland
Contact: Annette Kuhn, MD         
Cantonal Hospital Frauenfeld Recruiting
Frauenfeld, Switzerland
Contact: Volker Viereck, MD         
United Kingdom
Basingstoke and North Hampshire Hospital Recruiting
Basingstoke, United Kingdom
Contact: Christian Phillips, MD         
Birmingham Women's Hospital NHS foundation trust Not yet recruiting
Birmingham, United Kingdom
Contact: Philip Toozs Hobson         
King's College Hospital Not yet recruiting
London, United Kingdom
Contact: Angela Rantell         
St Mary's Hospital Not yet recruiting
London, United Kingdom
Contact: Vik Khullar, MD         
Sponsors and Collaborators
Cork University Hospital
FOTONA, D.O.O
Investigators
Principal Investigator: Barry O'Reilly, Professor University College Cork

Responsible Party: Barry O'Reilly, Professor, Cork University Hospital
ClinicalTrials.gov Identifier: NCT03098992     History of Changes
Other Study ID Numbers: FOTONA-Incontilase
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders