Lyrette: Renewing Continence Objective and Subjective Efficacy Study

Stress Urinary Incontinence Clinical Trial

— ROSE  

Official title:

Lyrette: Renewing Continence Objective and Subjective Efficacy Study

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01455779
• Other study ID #: CP-3375
• Status: Unknown status
• Phase: N/A
• First received: October 13, 2011
• Last updated: December 8, 2014
• Start date: September 2011
• Est. completion date: July 2015

Study information

• Verified date: November 2013
• Source: Verathon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 54
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Bladder Control	Arlington Heights	Illinois
United States	Female Pelvic Medicine and Urogynecology	Grand Rapids	Michigan
United States	Tri Valley Urology Medical Group	Murrieta	California
United States	Dial Research, Tennessee Women's Care	Nashville	Tennessee
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	Women's Health Institute of Illinois	Oak Lawn	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Verathon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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
Secondary	IQOL Score	An increase in overall IQOL score from baseline to 36 months.	36 months from baseline
Secondary	Pad Weight	A 50% reduction in the amount of urine leaked during a 1-hour pad weight test	12 months
Secondary	Cough Test Results	A negative cough test	12 months