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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098992
Recruitment Status : Active, not recruiting
First Posted : April 4, 2017
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Fotona d.o.o.
Information provided by (Responsible Party):
Barry O'Reilly, Cork University Hospital

Tracking Information
First Submitted Date  ICMJE March 20, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
  • 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
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
  • 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
  • Improvement [ Time Frame: 6 and 12 months post-treatment ]
    Change in mean Cough Stress test score at 6 and 12 months post-treatment
  • 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
  • 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.
  • Subjective assessment of pain [ Time Frame: 6 months ]
    Patient reported assessment of pain during treatment
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of Fotona Smooth® Device for the Treatment of Stress Urinary Incontinence
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Stress Urinary Incontinence
Intervention  ICMJE
  • 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
  • Device: Fotona Dynamis Er:YAG Laser System with sham handpience
    Sham treatment with a sham handpiece and parameter presentations masked
Study Arms  ICMJE
  • Active Comparator: Fotona Dynamis Er:YAG Laser System
    Active treatment with Fotona Dynamis Er:YAG Laser System
    Intervention: Device: Fotona Dynamis Er:YAG Laser System
  • Sham Comparator: Fotona Dynamis Er:YAG Laser System with Sham handpience
    Sham treatment with a sham handpiece and parameter presentations masked
    Intervention: Device: Fotona Dynamis Er:YAG Laser System with sham handpience
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 11, 2019)
135
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2017)
120
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Greece,   Ireland,   Slovenia,   Switzerland,   United Kingdom
Removed Location Countries Portugal
 
Administrative Information
NCT Number  ICMJE NCT03098992
Other Study ID Numbers  ICMJE FOTONA-Incontilase
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Barry O'Reilly, Cork University Hospital
Study Sponsor  ICMJE Cork University Hospital
Collaborators  ICMJE Fotona d.o.o.
Investigators  ICMJE
Principal Investigator: Barry O'Reilly, Professor University College Cork
PRS Account Cork University Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP