Status:
UNKNOWN
Lyrette: Renewing Continence Objective and Subjective Efficacy Study
Lead Sponsor:
Verathon
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
35-60 years
Phase:
NA
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, seco...
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
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01455779
Start Date
September 1 2011
End Date
July 1 2015
Last Update
December 9 2014
Active Locations (6)
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1
Tri Valley Urology Medical Group
Murrieta, California, United States, 92562
2
Center for Bladder Control
Arlington Heights, Illinois, United States, 60004
3
Women's Health Institute of Illinois
Oak Lawn, Illinois, United States, 60453
4
Female Pelvic Medicine and Urogynecology
Grand Rapids, Michigan, United States, 49503