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

Primary Purpose

Stress Urinary Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lyrette
Sponsored by
Verathon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Stress Urinary Incontinence, Incontinence, SUI, Renessa

Eligibility Criteria

35 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Tri Valley Urology Medical Group
  • Center for Bladder Control
  • Women's Health Institute of Illinois
  • Female Pelvic Medicine and Urogynecology
  • Dial Research, Tennessee Women's Care
  • Eastern Virginia Medical School

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Lyrette

Arm Description

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.

Outcomes

Primary Outcome Measures

Primary Safety Endpoint will be assessed by the incidence of device related Serious Adverse Event's during the procedure and 30 days following treatment.
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.
The primary effectiveness endpoint will be the proportion of "dry" patients at the 12 month follow-up.

Secondary Outcome Measures

Secondary Safety Endpoint will be the evaluation of Adverse Events through all follow-up visits
The secondary safety endpoints will be the evaluation of Adverse Events through all follow-up visits.
IQOL Score
An increase in overall IQOL score from baseline to 36 months.
Pad Weight
A 50% reduction in the amount of urine leaked during a 1-hour pad weight test
Cough Test Results
A negative cough test

Full Information

First Posted
October 13, 2011
Last Updated
December 8, 2014
Sponsor
Verathon
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1. Study Identification

Unique Protocol Identification Number
NCT01455779
Brief Title
Lyrette: Renewing Continence Objective and Subjective Efficacy Study
Acronym
ROSE
Official Title
Lyrette: Renewing Continence Objective and Subjective Efficacy Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Verathon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Stress Urinary Incontinence, Incontinence, SUI, Renessa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lyrette
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
Lyrette
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Safety Endpoint will be assessed by the incidence of device related Serious Adverse Event's during the procedure and 30 days following treatment.
Description
Safety will be assessed by the incidence of device related Serious Adverse Events's during the procedure and 30 days following treatment.
Time Frame
30 days
Title
Primary Effectiveness Endpoint will be the proportion of "dry" patients at the 12 month follow-up.
Description
The primary effectiveness endpoint will be the proportion of "dry" patients at the 12 month follow-up.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Secondary Safety Endpoint will be the evaluation of Adverse Events through all follow-up visits
Description
The secondary safety endpoints will be the evaluation of Adverse Events through all follow-up visits.
Time Frame
36 months
Title
IQOL Score
Description
An increase in overall IQOL score from baseline to 36 months.
Time Frame
36 months from baseline
Title
Pad Weight
Description
A 50% reduction in the amount of urine leaked during a 1-hour pad weight test
Time Frame
12 months
Title
Cough Test Results
Description
A negative cough test
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Tri Valley Urology Medical Group
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Center for Bladder Control
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60004
Country
United States
Facility Name
Women's Health Institute of Illinois
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Female Pelvic Medicine and Urogynecology
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Dial Research, Tennessee Women's Care
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

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