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Lyrette: Renewing Continence Objective and Subjective Efficacy Study (ROSE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Verathon
ClinicalTrials.gov Identifier:
NCT01455779
First received: October 13, 2011
Last updated: November 20, 2013
Last verified: November 2013

October 13, 2011
November 20, 2013
September 2011
July 2015   (final data collection date for primary outcome 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. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Safety will be assessed by the incidence of device related Serious Adverse Events's during the procedure and 30 days following treatment.
  • Primary Effectiveness Endpoint will be the proportion of "dry" patients at the 12 month follow-up. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The primary effectiveness endpoint will be the proportion of "dry" patients at the 12 month follow-up.
Same as current
Complete list of historical versions of study NCT01455779 on ClinicalTrials.gov Archive Site
  • Secondary Safety Endpoint will be the evaluation of Adverse Events through all follow-up visits [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    The secondary safety endpoints will be the evaluation of Adverse Events through all follow-up visits.
  • IQOL Score [ Time Frame: 36 months from baseline ] [ Designated as safety issue: No ]
    An increase in overall IQOL score from baseline to 36 months.
  • Pad Weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    A 50% reduction in the amount of urine leaked during a 1-hour pad weight test
  • Cough Test Results [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    A negative cough test
  • Secondary Safety Endpoint will be the evaluation of Adverse Events through all follow-up visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The secondary safety endpoints will be the evaluation of Adverse Events through all follow-up visits.
  • IQOL Score [ Time Frame: 12 months from baseline ] [ Designated as safety issue: No ]
    An increase in overall IQOL score from baseline to 12 months.
  • Pad Weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    A 50% reduction in the amount of urine leaked during a 1-hour pad weight test
  • Cough Test Results [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    A negative cough test
Not Provided
Not Provided
 
Lyrette: Renewing Continence Objective and Subjective Efficacy Study
Lyrette: Renewing Continence Objective and Subjective Efficacy Study

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stress Urinary Incontinence
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.

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.

Intervention: Device: Lyrette
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
54
July 2015
July 2015   (final data collection date for primary outcome measure)

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
Female
35 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01455779
CP-3375
No
Verathon
Verathon
Not Provided
Not Provided
Verathon
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP