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Lyrette: Renewing Continence Objective and Subjective Efficacy Study (ROSE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Verathon
ClinicalTrials.gov Identifier:
NCT01455779
First received: October 13, 2011
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to demonstrate the treatment efficacy of the Lyrette® System in women most likely to be treated in an office setting for the condition of stress urinary incontinence, secondary to urethral hypermobility.


Condition Intervention
Stress Urinary Incontinence
Device: Lyrette

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lyrette: Renewing Continence Objective and Subjective Efficacy Study

Resource links provided by NLM:


Further study details as provided by Verathon:

Primary Outcome Measures:
  • Primary Safety Endpoint will be assessed by the incidence of device related Serious Adverse Event's during the procedure and 30 days following treatment. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Safety will be assessed by the incidence of device related Serious Adverse Events's during the procedure and 30 days following treatment.

  • Primary Effectiveness Endpoint will be the proportion of "dry" patients at the 12 month follow-up. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The primary effectiveness endpoint will be the proportion of "dry" patients at the 12 month follow-up.


Secondary Outcome Measures:
  • Secondary Safety Endpoint will be the evaluation of Adverse Events through all follow-up visits [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    The secondary safety endpoints will be the evaluation of Adverse Events through all follow-up visits.

  • IQOL Score [ Time Frame: 36 months from baseline ] [ Designated as safety issue: No ]
    An increase in overall IQOL score from baseline to 36 months.

  • Pad Weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    A 50% reduction in the amount of urine leaked during a 1-hour pad weight test

  • Cough Test Results [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    A negative cough test


Enrollment: 54
Study Start Date: September 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lyrette

The Verathon Transurethral RF System (Lyrette® System) is indicated for the treatment of female urinary stress incontinence (SUI) due to hypermobility in women who have failed conservative treatment and who are not candidates for surgical therapy.

The treatment is a 9 minute non-surgical procedure completed using local anesthesia during a single office visit. Women are discharged home with no incisions, dressings, or catheters immediately following treatment.

Device: Lyrette

The Verathon Transurethral RF System (Lyrette® System) is indicated for the treatment of female urinary stress incontinence (SUI) due to hypermobility in women who have failed conservative treatment and who are not candidates for surgical therapy.

The treatment is a 9 minute non-surgical procedure completed using local anesthesia during a single office visit. Women are discharged home with no incisions, dressings, or catheters immediately following treatment.


Detailed Description:

This is a prospective, open-label, single arm clinical study to evaluate the Lyrette System (formerly Renessa System) in a population likely to be treated in a physician's office.

  Eligibility

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 35 to 60 years
  • Female gender
  • Ability to complete all study requirements
  • Body Mass Index ≤ 35
  • Incontinence Quality of Life score (IQOL) ≥ 55
  • Leak Point Pressure (LPP) ≥ 90 cm H2O and
  • Maximal Urethral Closure Pressure (MUCP) ≥ 45 cm H2O
  • 3 to10 stress leaks recorded in the 3 day voiding diary
  • Clinical history of stress urinary incontinence for ≥ 12 months
  • Clinical diagnosis of stress urinary incontinence by study physician
  • Clinical diagnosis of mixed incontinence with predominant stress component.
  • Clinical diagnosis of bladder outlet hypermobility by a study physician
  • Has failed conservative therapy (Kegels, biofeedback) and/or has not received conservative therapy for a period of at least 3 months prior to enrollment in the study.
  • Medical Epidemiologic, and Social Aspects of Aging (MESA)stress symptom percentage score greater than urge symptom percentage score
  • Post-void residual ≤ 100 cc with Stage II or lower pelvic organ prolapsed
  • Urethral length ≥ 3 cm
  • Is not a current smoker
  • If subject has children, at least 1 year has elapsed after child birth and cessation of breastfeeding for at least 3 months, at enrollment.

Exclusion Criteria:

  • ASA III or IV classification
  • Current or planned pregnancy within the next 12 months
  • Clinical diagnosis of detrusor overactivity by urodynamic evaluation
  • Clinical diagnosis of mixed urinary incontinence with predominant urge component
  • Clinical diagnosis of primary urge urinary incontinence
  • Clinical diagnosis of gravitational loss
  • Stage III, IV Pelvic Organ Prolapse
  • Less than 2 grams of urine leakage during 1 hour stress pad test
  • Previous surgery, RF micro-remodeling, or injection of bulking agents specifically for the treatment of urinary incontinence
  • Current incontinence treatment with electrical stimulation, biofeedback, and/or medications
  • Previous urethral and/or bladder surgery (excluding diagnostic endoscope)
  • Current urinary tract infection
  • History of chronic urinary tract infections
  • History of recurrent pyelonephritis
  • History of interstitial cystitis
  • History of upper or lower urinary tract neoplasm
  • History of upper or lower anatomic urinary tract abnormality or disorder
  • History of acute or chronic renal failure
  • Coagulopathy
  • Immunosuppression (pathological or medication induced)
  • Collagen vascular disease (scleroderma, etc.)
  • Presence of a pacemaker, AICD, or other electrical health maintenance device, bladder neuro-modulation device.
  • History of COPD or other obstructive pulmonary disease
  • Life expectancy < 12 months
  • Knowingly will be relocating out of practice area within 12 months of initiation of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455779

Locations
United States, California
Tri Valley Urology Medical Group
Murrieta, California, United States, 92562
United States, Illinois
Center for Bladder Control
Arlington Heights, Illinois, United States, 60004
Women's Health Institute of Illinois
Oak Lawn, Illinois, United States, 60453
United States, Michigan
Female Pelvic Medicine and Urogynecology
Grand Rapids, Michigan, United States, 49503
United States, Tennessee
Dial Research, Tennessee Women's Care
Nashville, Tennessee, United States, 37203
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Verathon
  More Information

No publications provided

Responsible Party: Verathon
ClinicalTrials.gov Identifier: NCT01455779     History of Changes
Other Study ID Numbers: CP-3375
Study First Received: October 13, 2011
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Verathon:
Stress Urinary Incontinence
Incontinence
SUI
Renessa

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

ClinicalTrials.gov processed this record on November 24, 2014