Supplemental Evidence and Data Request on Nonsurgical Treatments for Urinary Incontinence in Adult Women: A Systematic Review Update, 34950-34952 [2017-15799]

Download as PDF 34950 Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Notices Board of Governors of the Federal Reserve System, July 24, 2017. Yao-Chin Chao, Assistant Secretary of the Board. [FR Doc. 2017–15871 Filed 7–26–17; 8:45 am] BILLING CODE 6210–01–P mstockstill on DSK30JT082PROD with NOTICES Notice of Proposals To Engage in or To Acquire Companies Engaged in Permissible Nonbanking Activities The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y, (12 CFR part 225) to engage de novo, or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies. Unless otherwise noted, these activities will be conducted throughout the United States. Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act. Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than August 11, 2017. A. Federal Reserve Bank of New York (Ivan Hurwitz, Vice President) 33 Liberty Street, New York, New York 10045–0001. Comments can also be sent electronically to Comments.applications@ny.frb.org: 1. China Merchants Group Limited, Hong Kong Special Administrative Region, the People’s Republic of China; to engage de novo in extending credit and servicing loans and the leasing of personal property through CIMC Leasing USA Inc., Oakbrook Terrace, Illinois, pursuant to sections 225.28(b)(1) and 225.28(b)(3) of Regulation Y. Board of Governors of the Federal Reserve System, July 24, 2017. Yao-Chin Chao, Assistant Secretary of the Board. BILLING CODE 6210–01–P VerDate Sep<11>2014 19:17 Jul 26, 2017 Jkt 241001 Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Nonsurgical Treatments for Urinary Incontinence in Adult Women: A Systematic Review Update FEDERAL RESERVE SYSTEM [FR Doc. 2017–15872 Filed 7–26–17; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for Supplemental Evidence and Data Submissions. AGENCY: The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Nonsurgical Treatments for Urinary Incontinence in Adult Women: A Systematic Review Update, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. DATES: Submission Deadline on or before August 28, 2017. ADDRESSES: Email submissions: SEADS@epcsrc.org. Print submissions: Mailing Address: Portland VA Research Foundation, Scientific Resource Center, ATTN: Scientific Information Packet Coordinator, P.O. 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: Ryan McKenna, Telephone: 503–220– 8262 ext. 51723 or Email: SEADS@epcsrc.org. SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Nonsurgical Treatments for Urinary Incontinence in Adult Women: A Systematic Review Update. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). The EPC 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 SUMMARY: PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 literature by requesting information from the public (e.g., details of studies conducted). We are looking for studies that report on Nonsurgical Treatments for Urinary Incontinence in Adult Women: A Systematic Review Update, including those that describe adverse events. The entire research protocol, including the key questions, is also available online at: https://effective healthcare.ahrq.gov/index.cfm/searchfor-guides-reviews-and-reports/ ?pageaction=display product&productid=2479. This is to notify the public that the EPC Program would find the following information on Nonsurgical Treatments for Urinary Incontinence in Adult Women: A Systematic Review Update helpful: D A list of completed studies that your organization has sponsored for this indication. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number. D For completed studies that do not have results on ClinicalTrials.gov, please provide 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. D A list of ongoing studies that your organization 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. D Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this indication and an index outlining the relevant information in each submitted file. Your contribution will be very beneficial to the EPC Program. Materials submitted must be publicly available or able to 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 EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter. E:\FR\FM\27JYN1.SGM 27JYN1 Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Notices The draft of this review will be posted on AHRQ’s EPC 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, please sign up for the email list at: https:// www.effectivehealthcare.ahrq.gov/ index.cfm/join-the-email-list1/. The systematic review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions. The Key Questions mstockstill on DSK30JT082PROD with NOTICES Key Question (KQ) 1 What are the benefits and harms of nonpharmacological treatments of UI in women, and how do they compare with each other? I. How do nonpharmacological treatments affect UI, UI severity and frequency, and quality of life when compared with no active treatment? II. What are the harms from nonpharmacological treatments when compared with no active treatment? III. What is the comparative effectiveness of nonpharmacological treatments when compared with each other? IV. What are the comparative harms from nonpharmacological treatments when compared with each other? V. Which patient characteristics, including age, type of UI, severity of UI, baseline diseases that affect UI, adherence to treatment recommendations, and comorbidities, modify the effects of nonpharmacological treatments on patient outcomes, including continence, quality of life, and harms? KQ 2 What are the benefits and harms of pharmacological treatments of UI in women, and how do they compare with each other? I. How do pharmacological treatments affect UI, UI severity and frequency, and quality of life when compared with no active treatment? II. What are the harms from pharmacological treatments when compared with no active treatment? III. What is the comparative effectiveness of pharmacological treatments when compared with each other? IV. What are the comparative harms from pharmacological treatments when compared with each other? V. Which patient characteristics, including age, type of UI, severity of VerDate Sep<11>2014 19:17 Jul 26, 2017 Jkt 241001 UI, baseline diseases that affect UI, adherence to treatment recommendations, and comorbidities, modify the effects of the pharmacological treatments on patient outcomes, including continence, quality of life, and harms? KQ 3 What are the comparative benefits and harms of nonpharmacological versus pharmacological treatments of UI in women? I. What is the comparative effectiveness of nonpharmacological treatments when compared with pharmacological treatments? II. What are the comparative harms of nonpharmacological treatments when compared with pharmacological treatments? III. Which patient characteristics, including age, type of UI, severity of UI, baseline diseases that affect UI, adherence to treatment recommendations, and comorbidities, modify the relative effectiveness of nonpharmacological and pharmacological treatments on patient outcomes, including continence, quality of life, and harms? KQ 4 What are the benefits and harms of combined nonpharmacological and pharmacological treatment of UI in women? I. How do combined nonpharmacological and pharmacological treatments affect UI, UI severity and frequency, and quality of life when compared with no active treatment? II. What are the harms from combined nonpharmacological and pharmacological treatments when compared with no active treatment? III. What is the comparative effectiveness of combined nonpharmacological and pharmacological treatments when compared with nonpharmacological treatment alone? IV. What is the comparative effectiveness of combined nonpharmacological and pharmacological treatments when compared with pharmacological treatment alone? V. What is the comparative effectiveness of combined nonpharmacological and pharmacological treatments when compared with other combined nonpharmacological and pharmacological treatments? PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 34951 VI. What are the comparative harms from combined nonpharmacological and pharmacological treatments when compared with nonpharmacological treatment alone, pharmacological treatment alone, or other combined treatments? VII. Which patient characteristics, including age, type of UI, severity of UI, baseline diseases that affect UI, adherence to treatment recommendations, and comorbidities, modify the effects of combined nonpharmacological and pharmacological treatments on patient outcomes, including continence, quality of life, and harms? PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings) Populations Inclusion Adult and elderly (as defined by authors) women with symptoms of UI (as defined by authors). Subpopulations I. Women athletes and those engaging in high-impact physical activities II. Older women (whether ‘‘elderly’’ or just older than a younger analyzed subgroup, as defined by authors) III. Women in the military or veterans IV. Racial and ethnic minorities Exclusion If >10% of study participants are children or adolescents, men, pregnant women, institutionalized or hospitalized participants, have UI caused by neurological disease or dual fecal and urinary incontinence. Intervention/Exposure Inclusion Nonpharmacological interventions: Health education about UI; behavioral therapy, including ‘‘lifestyle’’ interventions (e.g., dietary modifications, weight loss, fluid restriction), bladder training; biofeedback; pelvic floor muscle training and other physical therapy; vaginal cones/weights, bladder supports (e.g., Impressa®); therapeutic pessaries; electrical stimulation (e.g., posterior tibial nerve stimulation, sacral neuromodulation, intravaginal electrical stimulation); magnetic stimulation; urethral plugs and patches; urethral bulking, including transurethral or periurethral injections. Pharmacological interventions: Estrogen preparations (topical estrogen); antimuscarinics (e.g., oxybutynin E:\FR\FM\27JYN1.SGM 27JYN1 34952 Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Notices chloride, trospium chloride, darifenacin, solifenacin succinate, fesoterodine, tolterodine, propiverine); calcium channel blockers (e.g., nimodipine); botulinum toxin injections; TRPV1 antagonists (e.g., resiniferatoxin); antidepressants (e.g., tricyclics, SSRI, SNRI); beta-3 adenoreceptor agonists (e.g., mirabegron). Combinations of eligible nonpharmacological and pharmacological interventions. Exclusion Interventions not available in the United States and surgical treatments. Comparator Inclusion Other eligible nonpharmacological interventions, other eligible pharmacological interventions, other eligible combination interventions, no active treatment or placebo. Exclusion Noneligible interventions, including surgery. Outcomes mstockstill on DSK30JT082PROD with NOTICES Inclusion Measures of UI: Pad tests and other measures of leakage volumes; incontinence counts/frequency (e.g., by diary), including urgency UI counts/ frequency and stress UI counts/ frequency; physical examination (e.g., cough stress test); complete remission, improvement (partial remission), worsening, no change; subjective bladder control; patient satisfaction with intervention; need to use protection. Quality of life and related questionnaires: Generic, validated; UIspecific, validated. Other patient-centered outcomes, based on the findings of the contextual question (what defines a successful outcome). Adverse events. Exclusion Bladder and pelvic tests that do not measure UI specifically or are used for diagnostic purposes (e.g., urodynamic testing, pelvic muscle strength); urination measures that do not measure UI specifically (e.g., total voids [that include nonincontinence voids], catheterization, postvoid residuals, urinary retention, perceived micturition difficulty). Timing Inclusion Minimum 4 weeks follow up (since the start of treatment). VerDate Sep<11>2014 19:17 Jul 26, 2017 Jkt 241001 Exclusion Exclusion Unable to read or translate. None. Settings Sharon B. Arnold, Deputy Director. Inclusion [FR Doc. 2017–15799 Filed 7–26–17; 8:45 am] Interventions provided in primary care or specialized clinic or equivalent by any healthcare provider; participants are community-dwelling. Exclusion Surgical, institutionalized, or inhospital settings. Country setting. Inclusion Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request Agency for Healthcare Research and Quality, HHS. ACTION: Notice. Exclusion None. This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ‘‘The AHRQ Safety Program for Improving Antibiotic Use.’’ This proposed information collection was previously published in the Federal Register on May 5, 2017, and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment. DATES: Comments on this notice must be received by August 28, 2017. ADDRESSES: Written comments should be submitted to: AHRQ’s OMB Desk Officer by fax at (202) 395–6974 (attention: AHRQ’s desk officer) or by email at OIRA_submission@ omb.eop.gov (attention: AHRQ’s desk officer). SUMMARY: Study Designs Inclusion For effectiveness outcomes: Randomized controlled trials (RCTs), with no minimum sample size, including pooled individual patient data from RCTs; nonrandomized comparative studies that used strategies to reduce bias (e.g., adjustment, stratification, matching, or propensity scores), N≥50 women per group (N≥100 women total). For harms outcomes: RCTs, with no minimum sample size; nonrandomized longitudinal comparative studies (regardless of strategies to reduce bias), including registries or large databases, N≥50 women per group (N≥100 women total); single arm longitudinal studies, including registries, large databases, and large case series N≥100 women; casecontrol studies (where cases are selected based on presence of harm), N≥50 female cases and ≥50 female controls (N≥100 women total). All outcomes: Published, peerreviewed articles or unpublished data from the Food and Drug Administration (FDA) or from the Web site ClinicalTrials.gov. Exclusion For effectiveness outcomes: Single group, case-control, and case report/ series studies; nonrandomized comparative studies with only crude or unadjusted data. Publication language. Inclusion Any. Frm 00030 DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Any geographic area. PO 00000 BILLING CODE 4160–90–P Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427–1477, or by email at doris.lefkowitz@AHRQ.hhs.gov. SUPPLEMENTARY INFORMATION: Proposed Project In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501–3521, AHRQ invites the public to comment on this proposed information collection. Antibiotics can have serious adverse effects including Clostridium difficile infections, organ dysfunction, allergic reactions, and the development of antibiotic resistance on both a patient level and population level. This project will assist acute care, long-term care and ambulatory care settings across the United States in adopting and implementing antibiotic stewardship E:\FR\FM\27JYN1.SGM 27JYN1

Agencies

[Federal Register Volume 82, Number 143 (Thursday, July 27, 2017)]
[Notices]
[Pages 34950-34952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15799]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Nonsurgical Treatments 
for Urinary Incontinence in Adult Women: A Systematic Review Update

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

ACTION: Request for Supplemental Evidence and Data Submissions.

-----------------------------------------------------------------------

SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review of Nonsurgical 
Treatments for Urinary Incontinence in Adult Women: A Systematic Review 
Update, which is currently being conducted by the AHRQ's Evidence-based 
Practice Centers (EPC) Program. Access to published and unpublished 
pertinent scientific information will improve the quality of this 
review.

DATES: Submission Deadline on or before August 28, 2017.

ADDRESSES: 
    Email submissions: src.org">SEADS@epc-src.org.
    Print submissions: Mailing Address: Portland VA Research 
Foundation, Scientific Resource Center, ATTN: Scientific Information 
Packet Coordinator, P.O. 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: Ryan McKenna, Telephone: 503-220-8262 
ext. 51723 or Email: src.org">SEADS@epc-src.org.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Nonsurgical Treatments 
for Urinary Incontinence in Adult Women: A Systematic Review Update. 
AHRQ is conducting this systematic review pursuant to Section 902(a) of 
the Public Health Service Act, 42 U.S.C. 299a(a).
    The EPC 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 Nonsurgical Treatments for Urinary Incontinence in Adult 
Women: A Systematic Review Update, including those that describe 
adverse events. The entire research protocol, including the key 
questions, is also available online at: https://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=2479.
    This is to notify the public that the EPC Program would find the 
following information on Nonsurgical Treatments for Urinary 
Incontinence in Adult Women: A Systematic Review Update helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, please provide 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.
    [ssquf] A list of ongoing studies that your organization 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.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution will be very beneficial to the EPC Program. 
Materials submitted must be publicly available or able to 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 EPC 
Program. This is a voluntary request for information, and all costs for 
complying with this request must be borne by the submitter.

[[Page 34951]]

    The draft of this review will be posted on AHRQ's EPC 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, please sign up for 
the email list at: https://www.effectivehealthcare.ahrq.gov/index.cfm/join-the-email-list1/.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions.

The Key Questions

Key Question (KQ) 1

    What are the benefits and harms of nonpharmacological treatments of 
UI in women, and how do they compare with each other?

I. How do nonpharmacological treatments affect UI, UI severity and 
frequency, and quality of life when compared with no active treatment?
II. What are the harms from nonpharmacological treatments when compared 
with no active treatment?
III. What is the comparative effectiveness of nonpharmacological 
treatments when compared with each other?
IV. What are the comparative harms from nonpharmacological treatments 
when compared with each other?
V. Which patient characteristics, including age, type of UI, severity 
of UI, baseline diseases that affect UI, adherence to treatment 
recommendations, and comorbidities, modify the effects of 
nonpharmacological treatments on patient outcomes, including 
continence, quality of life, and harms?

KQ 2

    What are the benefits and harms of pharmacological treatments of UI 
in women, and how do they compare with each other?

I. How do pharmacological treatments affect UI, UI severity and 
frequency, and quality of life when compared with no active treatment?
II. What are the harms from pharmacological treatments when compared 
with no active treatment?
III. What is the comparative effectiveness of pharmacological 
treatments when compared with each other?
IV. What are the comparative harms from pharmacological treatments when 
compared with each other?
V. Which patient characteristics, including age, type of UI, severity 
of UI, baseline diseases that affect UI, adherence to treatment 
recommendations, and comorbidities, modify the effects of the 
pharmacological treatments on patient outcomes, including continence, 
quality of life, and harms?

KQ 3

    What are the comparative benefits and harms of nonpharmacological 
versus pharmacological treatments of UI in women?

I. What is the comparative effectiveness of nonpharmacological 
treatments when compared with pharmacological treatments?
II. What are the comparative harms of nonpharmacological treatments 
when compared with pharmacological treatments?
III. Which patient characteristics, including age, type of UI, severity 
of UI, baseline diseases that affect UI, adherence to treatment 
recommendations, and comorbidities, modify the relative effectiveness 
of nonpharmacological and pharmacological treatments on patient 
outcomes, including continence, quality of life, and harms?

KQ 4

    What are the benefits and harms of combined nonpharmacological and 
pharmacological treatment of UI in women?

I. How do combined nonpharmacological and pharmacological treatments 
affect UI, UI severity and frequency, and quality of life when compared 
with no active treatment?
II. What are the harms from combined nonpharmacological and 
pharmacological treatments when compared with no active treatment?
III. What is the comparative effectiveness of combined 
nonpharmacological and pharmacological treatments when compared with 
nonpharmacological treatment alone?
IV. What is the comparative effectiveness of combined 
nonpharmacological and pharmacological treatments when compared with 
pharmacological treatment alone?
V. What is the comparative effectiveness of combined nonpharmacological 
and pharmacological treatments when compared with other combined 
nonpharmacological and pharmacological treatments?
VI. What are the comparative harms from combined nonpharmacological and 
pharmacological treatments when compared with nonpharmacological 
treatment alone, pharmacological treatment alone, or other combined 
treatments?
VII. Which patient characteristics, including age, type of UI, severity 
of UI, baseline diseases that affect UI, adherence to treatment 
recommendations, and comorbidities, modify the effects of combined 
nonpharmacological and pharmacological treatments on patient outcomes, 
including continence, quality of life, and harms?

PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, 
Settings)

Populations

Inclusion
    Adult and elderly (as defined by authors) women with symptoms of UI 
(as defined by authors).

Subpopulations

I. Women athletes and those engaging in high-impact physical activities
II. Older women (whether ``elderly'' or just older than a younger 
analyzed subgroup, as defined by authors)
III. Women in the military or veterans
IV. Racial and ethnic minorities
Exclusion
    If >10% of study participants are children or adolescents, men, 
pregnant women, institutionalized or hospitalized participants, have UI 
caused by neurological disease or dual fecal and urinary incontinence.

Intervention/Exposure

Inclusion
    Nonpharmacological interventions: Health education about UI; 
behavioral therapy, including ``lifestyle'' interventions (e.g., 
dietary modifications, weight loss, fluid restriction), bladder 
training; biofeedback; pelvic floor muscle training and other physical 
therapy; vaginal cones/weights, bladder supports (e.g., 
Impressa[supreg]); therapeutic pessaries; electrical stimulation (e.g., 
posterior tibial nerve stimulation, sacral neuromodulation, 
intravaginal electrical stimulation); magnetic stimulation; urethral 
plugs and patches; urethral bulking, including transurethral or 
periurethral injections.
    Pharmacological interventions: Estrogen preparations (topical 
estrogen); antimuscarinics (e.g., oxybutynin

[[Page 34952]]

chloride, trospium chloride, darifenacin, solifenacin succinate, 
fesoterodine, tolterodine, propiverine); calcium channel blockers 
(e.g., nimodipine); botulinum toxin injections; TRPV1 antagonists 
(e.g., resiniferatoxin); antidepressants (e.g., tricyclics, SSRI, 
SNRI); beta-3 adeno-receptor agonists (e.g., mirabegron).
    Combinations of eligible nonpharmacological and pharmacological 
interventions.
Exclusion
    Interventions not available in the United States and surgical 
treatments.

Comparator

Inclusion
    Other eligible nonpharmacological interventions, other eligible 
pharmacological interventions, other eligible combination 
interventions, no active treatment or placebo.
Exclusion
    Noneligible interventions, including surgery.

Outcomes

Inclusion
    Measures of UI: Pad tests and other measures of leakage volumes; 
incontinence counts/frequency (e.g., by diary), including urgency UI 
counts/frequency and stress UI counts/frequency; physical examination 
(e.g., cough stress test); complete remission, improvement (partial 
remission), worsening, no change; subjective bladder control; patient 
satisfaction with intervention; need to use protection.
    Quality of life and related questionnaires: Generic, validated; UI-
specific, validated.
    Other patient-centered outcomes, based on the findings of the 
contextual question (what defines a successful outcome).
    Adverse events.
Exclusion
    Bladder and pelvic tests that do not measure UI specifically or are 
used for diagnostic purposes (e.g., urodynamic testing, pelvic muscle 
strength); urination measures that do not measure UI specifically 
(e.g., total voids [that include nonincontinence voids], 
catheterization, postvoid residuals, urinary retention, perceived 
micturition difficulty).

Timing

Inclusion
    Minimum 4 weeks follow up (since the start of treatment).
Exclusion
    None.

Settings

Inclusion
    Interventions provided in primary care or specialized clinic or 
equivalent by any healthcare provider; participants are community-
dwelling.
Exclusion
    Surgical, institutionalized, or in-hospital settings.
    Country setting.
Inclusion
    Any geographic area.
Exclusion
    None.

Study Designs

Inclusion
    For effectiveness outcomes: Randomized controlled trials (RCTs), 
with no minimum sample size, including pooled individual patient data 
from RCTs; nonrandomized comparative studies that used strategies to 
reduce bias (e.g., adjustment, stratification, matching, or propensity 
scores), N>=50 women per group (N>=100 women total).
    For harms outcomes: RCTs, with no minimum sample size; 
nonrandomized longitudinal comparative studies (regardless of 
strategies to reduce bias), including registries or large databases, 
N>=50 women per group (N>=100 women total); single arm longitudinal 
studies, including registries, large databases, and large case series 
N>=100 women; case-control studies (where cases are selected based on 
presence of harm), N>=50 female cases and >=50 female controls (N>=100 
women total).
    All outcomes: Published, peer-reviewed articles or unpublished data 
from the Food and Drug Administration (FDA) or from the Web site 
ClinicalTrials.gov.
Exclusion
    For effectiveness outcomes: Single group, case-control, and case 
report/series studies; nonrandomized comparative studies with only 
crude or unadjusted data.
    Publication language.
Inclusion
    Any.
Exclusion
    Unable to read or translate.

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017-15799 Filed 7-26-17; 8:45 am]
BILLING CODE 4160-90-P