Renessa Objective and Subjective Efficacy Study (ROSE)

This study is currently recruiting participants.

Verified November 2012 by Novasys Medical, Inc.

Sponsor:

Information provided by (Responsible Party):

Novasys Medical, Inc.

ClinicalTrials.gov Identifier:

NCT01455779

First received: October 13, 2011

Last updated: November 16, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 13, 2011
Last Updated Date	November 16, 2012
Start Date ^ICMJE	September 2011
Estimated Primary Completion Date	March 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 18, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01455779 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 18, 2011)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Renessa Objective and Subjective Efficacy Study
Official Title ^ICMJE	Renessa Objective and Subjective Efficacy Study
Brief Summary	The purpose of this study is to demonstrate the treatment efficacy of the Renessa® 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 Renessa System in a population likely to be treated in a physician's office.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Stress Urinary Incontinence
Intervention ^ICMJE	Device: RENESSA The Novasys Transurethral RF System (Renessa® 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 Arm (s)	Renessa The Novasys Transurethral RF System (Renessa® 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: RENESSA
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	120
Estimated Completion Date	March 2014
Estimated Primary Completion Date	March 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	35 Years to 60 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01455779
Other Study ID Numbers ^ICMJE	CP-3375
Has Data Monitoring Committee	No
Responsible Party	Novasys Medical, Inc.
Study Sponsor ^ICMJE	Novasys Medical, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Novasys Medical, Inc.
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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