Lyrette: Renewing Continence Objective and Subjective Efficacy Study
This trial is active, not recruiting.
|Condition||stress urinary incontinence|
|Start date||September 2011|
|End date||July 2015|
|Trial size||54 participants|
|Trial identifier||NCT01455779, CP-3375|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Murrieta, CA||Tri Valley Urology Medical Group||no longer recruiting|
|Arlington Heights, IL||Center for Bladder Control||no longer recruiting|
|Oak Lawn, IL||Women's Health Institute of Illinois||no longer recruiting|
|Grand Rapids, MI||Female Pelvic Medicine and Urogynecology||no longer recruiting|
|Nashville, TN||Dial Research, Tennessee Women's Care||no longer recruiting|
|Norfolk, VA||Eastern Virginia Medical School||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
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
Primary Effectiveness Endpoint will be the proportion of "dry" patients at the 12 month follow-up.
time frame: 12 months
Secondary Safety Endpoint will be the evaluation of Adverse Events through all follow-up visits
time frame: 36 months
time frame: 36 months from baseline
time frame: 12 months
Cough Test Results
time frame: 12 months
Female participants from 35 years up to 60 years old.
- 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.
- 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
- 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
|Official title||Lyrette: Renewing Continence Objective and Subjective Efficacy Study|
|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.|
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