[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.

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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 Access to published and unpublished 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