Stress Urinary IncontinenceROSENCT01455779
Lyrette: Renewing Continence Objective and Subjective Efficacy Study
A study testing Lyrette in people with Stress Urinary Incontinence, run by Verathon at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Lyrette
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2011to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Center for Bladder Control
Arlington Heights, Illinois, 60004
Female Pelvic Medicine and Urogynecology
Grand Rapids, Michigan, 49503
Tri Valley Urology Medical Group
Murrieta, California, 92562
Dial Research, Tennessee Women's Care
Nashville, Tennessee, 37203
Eastern Virginia Medical School
Norfolk, Virginia, 23507
Women's Health Institute of Illinois
Oak Lawn, Illinois, 60453
About this 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.
Read the 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Lyrette
- Keywords
- Stress Urinary Incontinence, Incontinence, SUI, Renessa
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LyretteDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Lyrette | Other | 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. Receives: Device: Lyrette |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
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.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 36 months
IQOL Score
An increase in overall IQOL score from baseline to 36 months.
Measured: 36 months from baseline
Pad Weight
A 50% reduction in the amount of urine leaked during a 1-hour pad weight test
Measured: 12 months
Cough Test Results
A negative cough test
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verathon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455779
- Sponsor's protocol ID
- CP-3375
- Acronym
- ROSE
- Status last verified
- Nov 2013
- First submitted
- 13 Oct 2011
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lyrette: Renewing Continence Objective and Subjective Efficacy Study
- ClinicalTrials.gov ID
- NCT01455779
- Acronym / sponsor ID
- ROSE / CP-3375
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress Urinary Incontinence, Incontinence, SUI, Renessa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (actual)
- Lead sponsor
- VerathonIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lyrette | Other | Device: LyretteThe 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. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Age 35 to 60 years
- Female gender
- Ability to complete all study requirements
- Body Mass Index ≤ 35
- Incontinence Quality of Life score (IQOL) ≥ 55
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LyretteThe 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. | Device | Lyrette |
Primary outcome
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
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
The primary effectiveness endpoint will be the proportion of "dry" patients at the 12 month follow-up.
4 secondary outcomes
Secondary Safety Endpoint will be the evaluation of Adverse Events through all follow-up visits
Time frame: 36 months
IQOL Score
Time frame: 36 months from baseline
Pad Weight
Time frame: 12 months
Cough Test Results
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lyrette in people with Stress Urinary Incontinence, run by Verathon at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2014.