[Federal Register Volume 78, Number 128 (Wednesday, July 3, 2013)]
[Notices]
[Pages 40149-40150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-15729]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Chronic Urinary Retention (CUR) 
Treatment

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for scientific information submissions.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public on medical 
devices to treat chronic urinary retention. Scientific information is 
being solicited to inform our review of chronic urinary retention (CUR) 
treatment, which is currently being conducted by the Evidence-based 
Practice Centers for the AHRQ Effective Health Care Program. Access to 
published and unpublished pertinent scientific information on medical 
devices to treat chronic urinary retention will improve the quality of 
this review. AHRQ is conducting this comparative effectiveness review 
pursuant to Section 1013 of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003, Public Law 108-173, and 
Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).

DATES: Submission Deadline on or before August 2, 2013.

ADDRESSES: Online submissions: http://effectivehealthcare.AHRQ.gov/index.cfm/submit-scientific-information-packets/. Please select the 
study for which you are submitting information from the list to upload 
your documents.
    Email submissions: src.org">SIPS@epc-src.org.
    Print submissions: Mailing Address: Portland VA Research 
Foundation, Scientific Resource Center, ATTN: Scientific Information 
Packet Coordinator, PO Box 69539, Portland, OR 97239.
    Shipping Address (FedEx, UPS, etc.): Portland VA Research 
Foundation, Scientific Resource Center, ATTN: Scientific Information 
Packet Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D 
71, Portland, OR 97239.

FOR FURTHER INFORMATION CONTACT: Robin Paynter, Research Librarian, 
Telephone: 503-220-8262 ext. 58652 or Email: src.org">SIPS@epc-src.org.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Effective Health Care (EHC) Program 
Evidence-based Practice Centers to complete a review of the evidence 
for chronic urinary retention (CUR) treatment.
    The EHC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on chronic urinary retention treatment, including those 
that describe adverse events, as specified in the key questions 
detailed below. The entire research protocol, including the key 
questions, is also available online at: http://www.effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1539.
    This notice is to notify the public that the EHC program would find 
the following information on medical devices to treat chronic urinary 
retention helpful:
     A list of completed studies your company has sponsored for 
this indication. In the list, indicate whether results are available on 
ClinicalTrials.gov along with the ClinicalTrials.gov trial number.
     For completed studies that do not have results on 
ClinicalTrials.gov, a summary, including the following elements: Study 
number, study period, design, methodology, indication and diagnosis, 
proper use instructions, inclusion and exclusion criteria, primary and 
secondary outcomes, baseline characteristics, number of patients 
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, 
effectiveness/efficacy, and safety results.
     A list of ongoing studies your company has sponsored for 
this indication. In the list, please provide the ClinicalTrials.gov 
trial number or, if the trial is not registered, the protocol for the 
study including a study number, the study period, design, methodology, 
indication and diagnosis, proper use instructions, inclusion and 
exclusion criteria, and primary and secondary outcomes.
     Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your company for this 
indication and an index outlining the relevant information in each 
submitted file.
    Your contribution is very beneficial to the Program. The contents 
of all will be made available to the public upon request. Materials 
submitted must be publicly available or can be made public. Materials 
that are considered confidential; marketing materials; study types not 
included in the review; or information on indications not included in 
the review cannot be used by the Effective Health Care Program. This is 
a voluntary request for information, and all costs for complying with 
this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EHC program Web 
site and available for public comment for a period of 4 weeks. If you 
would like to be notified when the draft is posted,

[[Page 40150]]

please sign up for the email list at: http://effectivehealthcare.AHRQ.gov/index.cfm/join-the-email-list1/.

Key Questions

    KQ 1: What is the effectiveness and comparative effectiveness of 
treatments for CUR in adults:
     With male-specific etiologies?
     With female-specific etiologies?
     With non-sex-specific etiologies?
    KQ 1a: What patient or condition characteristics (e.g., age, 
severity, etc.) modify the effectiveness of treatment?
    KQ 2: What are the harms and comparative harms of treatments for 
CUR in adults:
     With male-specific etiologies?
     With female-specific etiologies?
     With non-sex-specific etiologies?
    KQ 2a: What patient or condition characteristics (e.g., age, 
severity, etc.) modify the harms of treatment?

    Dated: June 21, 2013.
Carolyn M. Clancy,
AHRQ, Director.
[FR Doc. 2013-15729 Filed 7-2-13; 8:45 am]
BILLING CODE 4160-90-M