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

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.

Study Overview

• Status: Unknown
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Lyrette

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint will be assessed by the incidence of device related Serious Adverse Event's during the procedure and 30 days following treatment.	Safety will be assessed by the incidence of device related Serious Adverse Events's during the procedure and 30 days following treatment.	30 days
Primary Effectiveness Endpoint will be the proportion of "dry" patients at the 12 month follow-up.	The primary effectiveness endpoint will be the proportion of "dry" patients at the 12 month follow-up.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Safety Endpoint will be the evaluation of Adverse Events through all follow-up visits	The secondary safety endpoints will be the evaluation of Adverse Events through all follow-up visits.	36 months
IQOL Score	An increase in overall IQOL score from baseline to 36 months.	36 months from baseline
Pad Weight	A 50% reduction in the amount of urine leaked during a 1-hour pad weight test	12 months
Cough Test Results	A negative cough test	12 months

Collaborators and Investigators

• Sponsor: Verathon

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: October 13, 2011
• First Submitted That Met QC Criteria: October 18, 2011
• First Posted (Estimate): October 20, 2011

Study Record Updates

• Last Update Posted (Estimate): December 9, 2014
• Last Update Submitted That Met QC Criteria: December 8, 2014
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Incontinence; Stress Urinary Incontinence; SUI; Renessa
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: CP-3375

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No