Lyrette: Renewing Continence Objective and Subjective Efficacy Study

NCT01455779 | Unknown

• 1 other identifier: CP-3375
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 6

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.

Conditions

Stress Urinary Incontinence

Keywords

Stress Urinary Incontinence; Incontinence; SUI; Renessa

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months

Secondary Outcomes (4)

• Secondary Safety Endpoint will be the evaluation of Adverse Events through all follow-up visits

  36 months

• IQOL Score

  36 months from baseline

• Pad Weight

  12 months

• Cough Test Results

  12 months

Study Arms (1)

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.

Device: Lyrette

Interventions

Lyrette DEVICE

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

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Verathon: lead

Study Sites (6)

Tri Valley Urology Medical Group

Murrieta, California, 92562, United States

Location

Center for Bladder Control

Arlington Heights, Illinois, 60004, United States

Location

Women's Health Institute of Illinois

Oak Lawn, Illinois, 60453, United States

Location

Female Pelvic Medicine and Urogynecology

Grand Rapids, Michigan, 49503, United States

Location

Dial Research, Tennessee Women's Care

Nashville, Tennessee, 37203, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 20, 2011
• Study Start: September 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 9, 2014

Record last verified: 2013-11

Locations

US (6)