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

NCT03098992 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2019-06-12

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Fotona d.o.o.

    collaborator INDUSTRY

  • Cork University Hospital

    lead OTHER

Principal Investigators

  • Barry O'Reilly, Professor · University College Cork

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2019-12-31
Completion
2020-06-30

Countries

  • Germany
  • Greece
  • Ireland
  • Slovenia
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03098992 on ClinicalTrials.gov