Is transurethral radiofrequency therapy, e.g.Renessa procedure, safe and effective, especially long term, for the treatment of stress urinary incontinence?

Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.: Is transurethral radiofrequency therapy, e.g.Renessa procedure, safe and effective, especially long term, for the treatment of stress urinary incontinence?
Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.): yes
If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:: Periurethral injection of bulking agents, sacral nerve stimulation (InterStim), percutaneous tibial nerve stimulation (PTNS).
What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.): Females of any age suffering from stress urinary incontinence.
Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.): Failure of conservative therapy, i.e. medication.
Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)
Describe any health-related risks, side effects, or harms that you are concerned about.: Long term efficacy.

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

AHRQ Priority Populations

Federal Health Care Program

Describe why this topic is important.
What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.): Developement of a coverage policy for Medicare patients.
Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.): yes
If yes, please explain:: Although there was generally enthusiasm regarding Renessa when it first became available, there is now significant concern regarding its long term effectiveness.

How will an answer to your research question be used or help inform decisions for you or your group?: WPS Medicare is working on a Local Coverage Determination (LCD).
Describe the timeframe in which an answer to your question is needed.: 6 months.
Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate): WPS Medicare is working on a Local Coverage Determination (LCD).

Are you making a suggestion as an individual or on behalf of an organization?: Organization

Please tell us how you heard about the Effective Health Care Program: Presentation at the CMS LCD Writers meeting, Elise Berliner

Effective Health Care Program