Lyrette: Renewing Continence Objective and Subjective Efficacy Study
NCT ID: NCT01455779
Last Updated: 2014-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
54 participants
INTERVENTIONAL
2011-09-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
60 Years
FEMALE
Yes
Sponsors
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Verathon
INDUSTRY
Responsible Party
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Locations
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Tri Valley Urology Medical Group
Murrieta, California, United States
Center for Bladder Control
Arlington Heights, Illinois, United States
Women's Health Institute of Illinois
Oak Lawn, Illinois, United States
Female Pelvic Medicine and Urogynecology
Grand Rapids, Michigan, United States
Dial Research, Tennessee Women's Care
Nashville, Tennessee, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Countries
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Other Identifiers
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CP-3375
Identifier Type: -
Identifier Source: org_study_id