Clinical trial NCT01455779: Lyrette: Renewing Continence Objective and Subjective Efficacy Study
Official title: Lyrette: Renewing Continence Objective and Subjective Efficacy Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Stress Urinary Incontinence
Incontinence
SUI
Renessa
Lead sponsor: Verathon
Sponsor class: INDUSTRY
First posted: 2011-10-20
Enrollment: 54
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Primary Safety Endpoint will be assessed by the incidence of device related Serious Adverse Event's during the procedure and 30 days following treatment.
timeFrame: 30 days
measure: Primary Effectiveness Endpoint will be the proportion of "dry" patients at the 12 month follow-up.
timeFrame: 12 months
Secondary outcomes:
measure: Secondary Safety Endpoint will be the evaluation of Adverse Events through all follow-up visits
timeFrame: 36 months
measure: IQOL Score
timeFrame: 36 months from baseline
measure: Pad Weight
timeFrame: 12 months
measure: Cough Test Results
timeFrame: 12 months
Other outcomes:
Locations:
city: Murrieta
country: United States
facility: Tri Valley Urology Medical Group
state: California
city: Arlington Heights
country: United States
facility: Center for Bladder Control
state: Illinois
city: Oak Lawn
country: United States
facility: Women's Health Institute of Illinois
state: Illinois
city: Grand Rapids
country: United States
facility: Female Pelvic Medicine and Urogynecology
state: Michigan
city: Nashville
country: United States
facility: Dial Research, Tennessee Women's Care
state: Tennessee
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
References: