URINARY INCONTINENCE TREATMENT NETWORK:  CONTINENCE TREATMENT CENTERS

Release Date:  October 12, 2000

RFA:  DK-01-018 (Limited competition, see RFA-DK-06-501)

National Institute of Diabetes and Digestive and Kidney Diseases
 
Letter of Intent Receipt Date:  December 7, 2000
Application Receipt Date:       December 28, 2000

PURPOSE
 
The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of 
the National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK) has a substantial and longstanding interest in research on 
bladder and urinary continence disorders.  Surgery, behavioral and 
medical therapies are the most common interventions for urinary 
incontinence, but their long-term outcomes have not been rigorously and 
systematically evaluated.  The NIDDK, in collaboration with the 
National Institute of Child Health and Human Development (NICHD), 
recently initiated the Urinary Incontinence Treatment Network (UITN).  
The primary goal of the UITN is to assess the long-term outcomes of the 
most commonly applied treatments for women with the diagnoses of stress 
and mixed urinary incontinence.  The UITN, a multi-center consortium of 
investigators, is supported by cooperative agreements and includes four 
vanguard Continence Treatment Centers (CTCs) and a single 
Biostatistical Coordinating Center(BCC).  These CTCs and the BCC have 
developed a protocol for implementation.  The purpose of this 
solicitation is to add up to four CTCs to the UITN to increase the 
number of patients enrolled and to enhance the ethnic and racial 
diversity of the study population. 

HEALTHY PEOPLE 2010
 
The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of “Healthy People 2010”, a 
PHS-led national activity for setting priority areas.  This 
RFA,”Urinary Incontinence Treatment Network-Continence Treatment 
Center”,is related to one or more of the priority areas.  Potential 
applicants may obtain a copy of “Healthy People 2010” at 
http://www.health.gov/healthypeople/.
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic, for-profit and non-profit 
institutions, public and private organizations, such as universities, 
colleges, hospitals, units of State and local government, and eligible 
agencies of the Federal government.  Foreign institutions are not 
eligible to apply.  Racial/ethnic minorities, women, and persons with 
disabilities are encouraged to apply as Principal Investigators.  

MECHANISM OF SUPPORT
 
The administrative and funding instrument to be used for these awards 
will be the cooperative agreement (U01).  The cooperative agreement is 
an assistance mechanism in which substantial NIDDK scientific and 
programmatic involvement is anticipated during the performance of the 
activity.  Under the cooperative agreement, the NIDDK"s purpose is to 
support and encourage the recipient"s activities by working jointly 
with the awardees in a partnership role, but not to assume direction, 
prime responsibility, or dominance.  Details of the responsibilities, 
relationships, and governance of a study funded under a cooperative 
agreement are described under the section entitled "Terms and 
Conditions of Award."
 
The total project period for applications submitted in response to this 
RFA must not exceed four years.  The anticipated award date is July 1, 
2001.  At this time, the NIDDK has not determined whether or how this 
solicitation will be continued beyond the present RFA.
 
FUNDS AVAILABLE
 
The NIDDK plans to make four awards.  Approximately $1,000,000 total 
cost (direct plus facilities and administrative costs) is expected to 
be available per year under this RFA.  It is anticipated that the award 
for each CTC will be about $250,000 total cost per year. 
 
The number of awards to be made is dependent on the receipt of a 
sufficient number of applications of high scientific merit and 
availability of funds.  Although this program is provided for in the 
financial plans of the NIDDK, awards pursuant to this RFA are 
contingent upon the availability of funds and the receipt of a 
sufficient number of applications of outstanding scientific and 
technical merit.
 
RESEARCH OBJECTIVES
 
A. Background

Urinary incontinence is a complex condition that affects females and 
males of all ages.  However, the prevalence of urinary incontinence is 
significantly higher in women than in men.  The factors influencing a 
patient’s decision to seek care are not well-described and the criteria 
by which the clinician selects therapy are not uniform.  Diagnostic 
criteria that delineate the various categories and subcategories of 
urinary incontinence are neither well defined nor utilized by many 
physicians.  In addition, factors that may predict a successful outcome 
of treatment have not been examined systematically.  There are numerous 
options available for the treatment of urinary incontinence, including 
surgery, pharmaceuticals, behavioral modification, and prostheses.  
Combinations of these therapies are frequently utilized.  Much of the 
literature pertaining to surgical intervention suggests that there is 
marked improvement for continence during the immediate and short-term 
post-operative period.  There are, however, very few well-designed 
observational studies that document the outcomes of invasive 
interventions over a longer period of follow-up.  The clinical studies 
reported to date suffer from a number of methodological shortcomings, 
including short follow-up, inadequate sample size (and thus low 
statistical power), uncertain diagnostic criteria for patient 
selection, inadequate measurement of quality of life, uncertainty about 
the relevance of reported clinical and patient-related outcomes, 
absence of documentation of post-operative complications, and high 
rates of patients lost to follow-up (thus introducing possible bias 
into results).

Despite the frequent use of surgery for urinary incontinence, there is 
no consensus on which procedure(s) offers the optimal long-term 
improvement and greatest patient satisfaction.   No rigorously 
conducted long-term studies have been performed to date that evaluate 
the most commonly performed surgical procedures utilizing accepted 
outcome measures.  In addition, although the use of pharmacological 
therapy and behavioral interventions prior to and post-surgery for 
urinary incontinence is common, these adjunctive interventions have not 
been evaluated in a standardized fashion.  Therefore, a well-designed 
prospective cohort study which assesses surgical, pharmacological, and 
behavioral approaches to the management of urinary incontinence is 
needed to provide both physicians and patients with the information 
necessary to make well-informed decisions about the best treatment 
options.  Recently, the NIDDK in collaboration with the NICHD and 
successful applicants (four CTCs and a BCC) from a prior RFA began 
protocol development for a prospective cohort study of surgical 
procedures for urinary incontinence.  It is anticipated that the 
awardees under this RFA will follow the protocol developed by this 
vanguard group of investigators. 

B.  Research Goals and Scope of the Activity
 
The purpose of this RFA is to solicit applications from investigators 
to serve as Continence Treatment Centers as members of the Urinary 
Incontinence Treatment Network to participate in a four-year 
prospective cohort study of women who have undergone different surgical 
procedures for urinary incontinence.  Information will also be 
collected in a standardized manner on the use of pharmacological and 
behavioral therapy in addition to surgery.  The study will be conducted 
collaboratively, using standardized entry criteria, uniform measures of 
outcome, validated instruments to assess quality of life and sexual 
function and other important patient-reported outcomes, over a four-
year period.  The investigators of the CTCs will also participate in 
data analysis, making presentations at scientific meetings, and writing 
manuscripts for publication in peer-reviewed journals.  It is 
anticipated that the personnel requirements of a CTC will include 
expertise in urology, urogynecology and behavioral therapy as related 
to the treatment of urinary incontinence in women.  

Applicants are encouraged to develop collaboration with other 
investigators as subcontractors to establish satellite centers in order 
to increase the available pool of eligible patients with the primary 
goal of enhancing racial and ethnic diversity of the population.

Phases Of Study For Budget Considerations

The study will be conducted in two phases with the activities described 
below.  This information is provided to assist applicants in developing 
an accurate budget.

Phase I (Months 1-42).  Recruitment of the full study cohort, 
collection of baseline and follow-up data on surgical, pharmacological, 
and behavioral treatments and interim data analysis.

During the first 12 months of this Phase, recruitment of patients to be 
enrolled in the cohort study will be carried out.  It is anticipated 
that the follow-up of patients will be completed in month 42.  Interim 
data analysis and reporting of selected findings will occur throughout 
this Phase.

Phase II (Months 43-48).  Final data analysis, reporting of results, 
and close-out of Continence Treatment Centers.

Study Components
 
Continence Treatment Center:  A Continence Treatment Center is an 
institution that is actively involved in the recruitment, evaluation, 
treatment, and follow-up of study participants.  It should consist of 
an interdisciplinary team of clinical investigators and persons 
experienced in behavioral therapy the appropriate support personnel, 
such as a research coordinator, data entry and clerical staff.  It is 
preferred that the clinical investigators at a CTC include both a 
urologist and a urogynecologist with demonstrated training and 
experience in the diagnosis and surgical treatment of female urinary 
incontinence.  Similar expertise is expected of each satellite center 
established under subcontracts from the CTC.  It is assumed that either 
a urologist or a urogynecologist will serve as the principal 
investigator of a CTC.  Other clinicians with similar training and 
experience may also be included as co-investigators.

It is not expected that each CTC will have expertise available to them 
for all of the currently utilized surgical procedures for urinary 
incontinence, nor is it required that CTCs alter their current clinical 
practice patterns to participate in this study.  It is expected, 
however, that each CTC will have experience with behavioral therapy and 
pharmacological treatment.  In addition, applicants are encouraged to 
complement their own clinical site surgical expertise and patient 
enrollment potential by establishing collaborations with other 
investigators who treat large numbers of women with urinary 
incontinence as previously described.  The primary focus of 
establishing satellite sites should be to enhance recruitment of racial 
and ethnic minority women.  CTC investigators must be capable of 
recruiting and retaining a sufficient number of women for the proposed 
cohort study.  CTCs should document the available target population 
from which study participants can be recruited.  This documentation 
should include, in tabular form, the number of female urinary 
incontinence patients for each five-year age range and by 
race/ethnicity. The investigators must also include in their 
description of their target population, the sources of referral of 
their patients, and the percentage who are prior treatment failures and 
the percentage of women who have undergone an initial surgical 
procedure for urinary incontinence. Realistic estimates of the rate of 
participation of women who have undergone surgery for urinary 
incontinence and are willing to join the study and be followed at the 
CTC must be provided.  The investigators should list and document 
strategies and techniques that have been found to be effective in 
patient recruitment for other clinical studies. The Principal 
Investigator and co-investigators should document previous experience 
in collaborative clinical investigation because they will be required 
to submit protocol-specified data to the BCC expeditiously and to 
collaborate with an already established Urinary Incontinence Treatment 
Network.  CTCs must work in concert with the BCC and must be willing to 
submit to data audits and other data quality control procedures as 
established by the study protocol. 

Steering and Planning Committee
 
The primary governing body of the study will be the Steering and 
Planning Committee comprised of each of the principal investigators of 
the CTCs and the BCC, the Chairperson of the Steering and Planning 
Committee, and the NIDDK Project Scientists (described in detail under 
Terms and Conditions).  The Steering and Planning Committee will, in 
addition to developing the study protocol (the vanguard CTCs and the 
BCC only), propose interim and final data analysis plans, and, along 
with their staff at the CTCs, recruit, perform surgery, provide 
pharmacological and behavioral therapy and provide follow-up for study 
participants.  The members of the Steering and Planning Committee will 
serve as chairs of the various subcommittees of the UITN.

Executive Committee

An Executive Committee, including the Chairperson of the Steering and 
Planning Committee, the Principal Investigator of the BCC, NIDDK 
Project Scientists, and when necessary, Chairpersons of the various 
subcommittees of the Steering and Planning Committee, will be 
established.  The purpose of this committee is to handle problems that 
arise during the interim of regularly scheduled Steering and Planning 
Committee meetings.
 
External Advisors
 
An independent group of experts in urology, urogynecology, 
biostatistics, clinical trials, behavioral medicine, nursing, and 
ethics who are not otherwise involved in the study will be recruited by 
the NIDDK to review periodically the progress of the study (described 
in detail under Terms and Conditions). 
 
Project Scientists
 
The NIDDK will identify two Project Scientists for the study.  The 
Project Scientists will assist the Steering and Planning Committee and 
external advisors in carrying out the study (described in detail under 
Terms and Conditions).  

TERMS AND CONDITIONS OF AWARD
 
The following terms and conditions will be incorporated into the award 
statement and provided to each Principal Investigator as well as to the 
institutional officials at the time of the award.  These terms are in 
addition to, not in lieu of, otherwise applicable Office of Management 
and Budget (OMB) administrative guidelines, HHS Grant Administration 
Regulations at 45 CFR Part 74 and 92, and other HHS, and NIH Grants 
Administration policy statements.
 
The participating Clinical Treatment Centers will have primary 
responsibility for recruiting a sufficient number of patients (with a 
focus on recruiting racial and ethnic minority participants), 
maintaining high rates of follow-up and data collection, obtaining data 
of high quality, and interpreting, presenting, and publishing findings 
from the study.  It is expected that the Clinical Treatment Centers 
will carry out the protocol now being developed by the four vanguard 
CTCs and the BCC.
 
1)Awardees Rights and Responsibilities

Awardees will have substantial and lead responsibilities in all tasks 
and activities.  These include patient recruitment and follow-up, data 
collection, quality control, final data analysis and interpretation, 
and preparation of publications. The awardees agree to work 
cooperatively with the other CTCs and the BCC and agree to follow the 
common protocol and Manual of Operations developed by vanguard CTCs and 
the BCC.  The awardees agree also to transmit all study data to the BCC 
for combination and analysis.  Awardees will retain custody of and have 
primary rights to their data developed under these awards, subject to 
Government (e.g., NIDDK, NIH, or PHS) rights or access consistent with 
current HHS, and NIH policies.
 
2) NIDDK Staff Responsibilities

The NIDDK will name two Project Scientists from within the Division of 
Kidney, Urologic and Hematologic Diseases whose function will be to 
assist the Steering and Planning Committee in carrying out the study.  
One Project Scientist will have clinical expertise in urinary 
incontinence and the other will have experience in the development and 
conduct of multicenter clinical studies.  The Project Scientists will 
be entitled to one vote between them for all key study group 
subcommittees.  The Project Scientists will have substantial 
scientific-programmatic involvement in quality control, interim data 
analysis, safety monitoring, and final data analysis and 
interpretation, preparation of publications, and coordination and 
performance monitoring.  The dominant role and prime responsibility for 
these activities resides with the awardees for the project as a whole, 
although specific tasks and activities in carrying out the studies will 
be shared among the awardees and the NIDDK Project Scientists.
 
The NIDDK Project Scientists will have voting membership on the 
Steering and Planning Committee and, as determined by that committee, 
its subcommittees and will have one vote between them. One of the NIDDK 
Project Scientists will also serve as Executive Secretary of the 
external advisors.
 
The NIDDK reserves the right to terminate or curtail the study (or an 
individual award) in the event of difficulties in recruiting 
participants to the study, maintaining high rates of patient follow-up 
and data collection and in timely data transmission, achieving high 
levels of data quality, working with cooperatively or other major 
breaches of the protocol, or human subject ethical issues that may 
dictate a premature termination.
 
3) Collaborative Responsibilities

The administrative and funding instrument used for this program is the 
cooperative agreement (U01), an “assistance” mechanism (rather than an 
“acquisition” mechanism), in which substantial NIH scientific and/or 
programmatic involvement with the awardees is anticipated during the 
performance of the activity.  Under the cooperative agreement, the NIH 
purpose is to support and/or stimulate the recipient’s activity by 
involvement in and otherwise working jointly with the award recipient 
in a partner role, but it is not to assume direction, prime 
responsibility, or a dominant role in the activity.  Consistent with 
the cooperative agreement concept, the dominant role and prime 
responsibility for the planned activity reside with the awardees for 
the project as a whole, although specific tasks and activities in 
carrying out the activity will be shared among the awardees and NIDDK 
Project Scientists.

The Steering and Planning Committee, composed of each of the Principal 
Investigators of the CTCs, the Principal Investigator of the BCC, the 
NIDDK Project Scientists, and the Chairman of the Steering and Planning 
Committee, will be the main governing board of the study.  This 
committee will have the primary responsibility for developing the 
common protocol (note the study protocol will be developed by the 
vanguard CTCs and the BCC), facilitating the conduct of participant 
follow-up, monitoring completeness of data collection and timely 
transmission of data to the BCC, and reporting the study results.  It 
will also be responsible for establishing study policies in such areas 
as access to patient data, ancillary studies, publications and 
presentations, and performance standards.  Each member of the Steering 
and Planning Committee will have one vote (NIDDK Project Scientists 
will have one vote between them), and all major scientific decisions 
will be determined by a majority vote of the Steering and Planning 
Committee.  A Chairperson will be chosen from among the Steering and 
Planning Committee members (but not one of the NIDDK Project Scientist 
or Biostatistical Coordinating Center Principal Investigator), or 
alternatively, from among experts in the field of urinary incontinence 
who are not participating directly in the study.  The vanguard CTCs and 
the BCC have developed a study protocol for implementation by the 
additional CTCs to be funded under this RFA. Subcommittees will be 
established from among members of the full complement of CTCs and the 
BCC on topics such as ancillary studies, publications and 
presentations, quality control, recruitment, protocol adherence, among 
others.   An independent group of External Advisors, selected by the 
Director, NIDDK, will review periodically the progress of the study.  
This group will include experts in the relevant medical, 
epidemiological, statistical, behavioral medicine, nursing, and ethics 
fields who are not otherwise involved in the study.  The External 
Advisors will review the study protocol and evaluate results, monitor 
data quality, participant safety, and provide operational and policy 
advice to the Steering and Planning Committee and to the NIDDK 
regarding the status of the study.  One of the NIDDK Project Scientists 
will serve as Executive Secretary of the group.

An Executive Committee comprised of the Steering and Planning Committee 
Chairperson, the Principal Investigator of the BCC, and the NIDDK 
Project Scientists also will be convened to effect management decisions 
required between the Steering and Planning Committee meetings, as 
needed for efficient progress of the cohort study.  Each member of the 
Executive Committee will have one vote (the NIDDK Project Scientists 
are entitled to one vote between them).  The Executive Committee will 
report its actions to the Steering and Planning Committee on a regular 
basis.  Meetings of the Executive Committee will generally be by 
conference call.

4) Arbitration
 
Any disagreement that may arise on scientific/programmatic matters 
(within the scope of the award) between recipients and the NIDDK may be 
brought to arbitration.  An arbitration panel will be composed of three 
members, one selected by the Steering and Planning Committee (with the 
NIDDK member not voting) or by the individual awardee in the event of 
an individual disagreement, a second member selected by NIDDK, and the 
third member selected by the two prior selected members. This special 
arbitration procedure in no way affects the awardee"s right to appeal 
an adverse action that is otherwise appealable in accordance with the 
PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 
CFR Part 16.
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups 
and their sub-populations must be included in all NIH supported 
biomedical and behavioral research projects involving human subjects, 
unless a clear and compelling rationale and justification is provided 
that inclusion is inappropriate with respect to the health of the 
subjects or the purpose of the research.  This policy results from the 
NIH Revitalization Act of 1993 (Section 492B of Public Law 1003-43).  
All investigators proposing research involving human subjects should 
read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities 
as Subjects in Clinical Research" published in the NIH Guide for Grants 
and Contracts on August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: 
The revisions relate to NIH defined Phase III clinical trials and 
require:  a) all applications or proposals and/or protocols to provide 
a description of plans to conduct analyses, as appropriate, to address 
differences by sex/gender and/or racial/ethnic groups, including 
subgroups if applicable, and b) all investigators to report accrual, 
and to conduct and report analyses, as appropriate, by sex/gender 
and/or racial/ethnic group differences.

Because the prevalence of urinary incontinence in women is 
substantially greater than in men and because treatment of urinary 
incontinence is markedly different in men and women, participation in 
the prospective cohort study planned under this initiative will be 
restricted to women.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age 
of 21) must be included in all human subjects research, conducted or 
supported by the NIH, unless there are scientific and ethical reasons 
not to include them. 

However, the NIDDK has determined that the urinary incontinence cohort 
study proposed in this solicitation does not require inclusion of 
children since the surgical techniques utilized for adult women are not 
routinely used in the treatment of urinary incontinence among children, 
and the etiology of urinary incontinence in children (male and female) 
is substantially different from that in adult women so as to require a 
separate cohort study.  

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained 
within specified page limitations.  Unless otherwise specified in an 
NIH solicitation, Internet addresses (URLs) should not be used to 
provide information necessary to the review because reviewers are under 
no obligation to view the Internet sites.  Reviewers are cautioned that 
their anonymity may be compromised when they directly access an 
Internet site.

LETTER OF INTENT

Prospective applicants are asked to submit, by December 7, 2000, a 
letter of intent that includes a descriptive title of the proposed 
research, name, address, and telephone number of the Principal 
Investigator, identities of other key personnel and participating 
institutions, and number and title of the RFA in response to which the 
application may be submitted.  Although a letter of intent is not 
required, is not binding, and does not enter into the review of a 
subsequent application, the information that it contains allows the 
NIDDK staff to estimate the potential review workload and avoid 
conflict of interest in the review. The letter of intent is to be sent 
to:
 
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes, Digestive, and Kidney Diseases
6707 Democracy Boulevard
Room 653, MSC 5452
Bethesda, MD 20892-5452 (for express/courier service use 20817)
Telephone:  (301) 594-8885
FAX: (301) 480-3505

APPLICATION PROCEDURES
 
Applications must be submitted on the standard research grant 
application form PHS 398 (rev. 4/98).  Application kits are available 
at most institutional offices of sponsored research and may be obtained 
from the Division of Extramural Outreach and Information Resources, 
National Institutes of Health, 6701 Rockledge Drive, MSC 7910, 
Bethesda, MD 20892-7910, telephone (301) 435-0714, E-mail: 
GrantsInfo@nih.gov.
 
The RFA label in the form PHS 398 (rev. 4/98) must be affixed to the 
bottom of the face page.  Failure to use this label could result in 
delayed processing of the application such that it may not reach the 
review committee in time for review.  For purposes of identification 
and processing, item 2 of the face page of the application must be 
marked "YES" and the RFA number and the words "Urinary Incontinence 
Treatment Network-Continence Treatment Centers" must be typed in. 
 
The RFA label and line 2 of the application should both indicate the 
RFA number.  The RFA label must be affixed to the bottom of the face 
page.  Failure to use the label could result in delayed processing of 
the application such that it may not reach the review committee in time 
for review.

The sample RFA label available at:  
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been 
modified to allow for this change.  Please note this is in pdf format.

Submit a signed, typewritten original of the application, including the 
checklist, and three signed photocopies in one package to:
 
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (For express/courier service)
 
At the time of submission, two additional copies of the application 
must be sent to:
 
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes, Digestive, and Kidney Diseases
6707 Democracy Boulevard
Room 653, MSC 5452
Bethesda, MD 20892- 5452 (for express/courier service use 20817)

Applications must be received by December 28, 2000.  If an application 
is received after this date it will be returned to the applicant 
without review.  The Center for Scientific Review  (CSR) will not 
accept any application in response to this RFA that is essentially the 
same as one currently pending initial review, unless the applicant 
withdraws the pending application.  

Information for Prospective Applicants

1. Information on the Web

A website will be established to contain questions of general interest 
asked by prospective applicants and their answers.  Prospective 
applicants are encouraged to check this website frequently while 
preparing an application.  The website can be reached through the 
following URL:  http://www.niddk.nih.gov/fund/crfo/rfas.htm.

2. Information to be Included in Applications

Information on Patient Pool: Detailed information on the number, age, 
race, ethnicity of women who have undergone surgery for urinary 
incontinence during the past three years at the applicant institution 
and any proposed satellite sites should be provided.  Information on 
the number of cases of new versus repeat surgical procedures in this 
patient population must also be provided.

Characterization of Pharmacological and Behavioral Treatment Received 
by Target Patient Population: The type of pharmacological treatment and 
behavioral therapy utilized must be described, including the frequency 
of their use as adjunctive to or prior to surgery for urinary 
incontinence.
 
Previous Experience and Prior Participation in a Collaborative Program:  
To promote the development of a collaborative program among the 
awardees, the applicant should present evidence of prior experience in 
working cooperatively with other institutions serving to recruit 
patients into studies of urinary incontinence and similar multicenter 
clinical studies and follow them long-term.  

Institutional Support: There should be documentation of strong 
institutional support for the study, including adequate space in which 
to conduct clinic activities. An organizational structure for the study 
should be set forth in the application, delineating lines of authority, 
communication and responsibility for dealing with problems in all 
general areas as well as stated willingness to follow the commonly 
agreed upon protocol developed by the vanguard CTCs and the BCC.

Suggested Personnel Requirements: The staff of a CTC should include 
urologists and urogynecologists with documented expertise in the 
treatment of female urinary incontinence.  The CTC team is anticipated 
to include members who perform in roles similar to those cited below.  
Members may be full or part-time and may serve in more than one 
capacity, as appropriate. The application must describe the expertise 
of key scientific, technical and administrative personnel and include a 
mechanism for replacing key professional or technical personnel should 
the need arise.   The following suggested roles are intended to be 
illustrative, not prescriptive:

o Principal Investigator to provide overall scientific guidance.

o Physician(s)/clinicians with expertise in the surgical, 
pharmacological and behavioral management of patients with urinary 
incontinence.  

o Project Coordinator who can provide full-time attention to 
administration and management of the cohort study.

o Individual(s) for clerical and technical support, including data 
entry.

3. Budget Preparation by Year
 
Applicants must include an adequately justified year-by-year budget, 
reflecting the major changes in the proposed activities as the study 
progresses through its various phases.  Note that budgets are NOT to be 
prepared in modules.  

Phase I (Months 1-42): The budget should reflect the level of effort 
necessary to recruit the entire study cohort and perform baseline and 
follow-up studies.  Interim reports and manuscripts describing the 
findings of the study will also be prepared.  

Phase II (Months 43-48): The major activities of this phase are patient 
close-out, collaboration with the BCC on analysis of the data, and 
preparation of final reports and manuscripts.

The project will require meeting approximately every four months in the 
Washington, D.C. area for each year of the study.  The travel budget 
should be estimated based on travel for the Principal Investigator, a 
co-investigator and a Study Coordinator. Key personnel from satellite 
centers may also be included in the travel budget.

REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and for responsiveness by the NIDDK.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further 
consideration.

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by the NIDDK in accordance with the review 
criteria stated below. As part of the initial merit review, all 
applications will receive a written critique and may undergo a process 
in which only those applications deemed to have the highest scientific 
merit, generally the top half of the applications under review, will be 
discussed, assigned a priority score, and receive a second level review 
by the National Diabetes and Digestive and Kidney Diseases Advisory 
Council.

Review Criteria

Applicants are expected to address issues identified under “Information 
To Be Included In Application.”  In the written comments, reviewers 
will be asked to discuss the following aspects of the application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the goals of this solicitation.  Each of the 
criteria will be addressed and considered in assigning the overall 
score, weighting them as appropriate for each application.  Note that 
the application does not need to be strong in all categories to be 
judged likely to have major scientific impact and thus deserve a high 
priority score.

The design for the cohort study has been developed by the vanguard CTCs 
and the BCC.  Therefore, it is not necessary to provide a proposed 
design in the grant application.

Review Criteria for Continence Treatment Centers

o Significance:  The applicant must demonstrate an understanding of the 
need for conducting a prospective cohort study of different surgical 
procedures for urinary incontinence in women.    

o Recruitment Capabilities:  The major emphasis of this RFA is the 
ability to recruit a large number of women who are candidates for 
surgery for urinary incontinence and follow them prospectively post-
surgery.  Recruitment of racial and ethnic minority women should be 
described in detail.  The importance of complete follow-up of study 
participants and collection of high quality data should be considered.  
The use of behavioral and pharmacological treatment prior to or after 
surgery must be considered.  Procedures for the maintenance of the 
long-term participation of study subjects must be provided.  The number 
of surgical procedures for new and repeat procedures for urinary 
incontinence must be described for the past three years.

o Investigator:  This criterion will focus on the following questions: 
Is there documented evidence of the investigator"s training and 
experience relevant to the operation of a CTC for urinary incontinence 
studies?  Is there evidence of successful collaborative interactions 
with other investigators under a common protocol in multi-center study?

o Environment:  Does the clinical environment in which the work will be 
done contribute to the probability of success?  Is there evidence of 
institutional support and commitment for the proposed program?

o Staff Qualifications:  Documented specific competence and relevant 
experience of professional, technical, and administrative staff 
pertinent to the operation of a CTC and the ability to carry out 
urinary incontinence treatment studies.

o Documented experience in surgical, pharmacological and behavioral 
treatment for urinary incontinence is required.  Demonstrated knowledge 
of clinical aspects of urinary incontinence is also required. 

o Resources:  Documented adequacy of the proposed facility and space is 
necessary.  Evidence of institutional support and commitment is also 
required.

o Data Management and Transmission: Adequacy of plans to ensure 
complete, reliable, and timely transmission of the study data.

o Cooperative Experience:  Evidence of prior experience in working 
collaboratively to carry out a developed study protocol.  Willingness 
to work cooperatively in this study is required.

o Collaboration between Centers: For those applications proposing 
collaborative efforts between two applicants from different 
institutions to form a single CTC additional factors to be considered 
would include the advantages of collaboration in terms of cost and 
recruitment capabilities.  The organizational/administrative plan for 
such arrangements needs to be clearly delineated.

In addition to the above criteria, in accordance with NIH policy, 
applications will also be reviewed with respect to the following.

o The reasonableness of the proposed budget.

o The adequacy of the proposed protection for humans or the 
environment, to the extent they may be adversely affected by the 
interventions proposed in the application.  The initial review group 
will also examine the safety of the research environment.

Schedule

Letter of Intent Receipt Date:  December 7, 2000
Application Receipt Date:       December 28, 2000
Special Review Committee:       March/April, 2001
NIDDK Advisory Council:         May, 2001
Anticipated Award Date:         July 1, 2001
 
AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit as determined by peer review

o Availability of funds

o Cost

o Geographic distribution 

o The frequency and type of surgical procedures exhibited by a CTC

o Recruitment of racial and ethnic minorities

INQUIRIES
 
Written and telephone inquiries concerning this RFA are strongly 
encouraged. 
 
Direct inquiries regarding programmatic issues to:
 
John W. Kusek, Ph.D.
Clinical Trials Program Director or
Leroy M. Nyberg, Ph.D., M.D.
Urology Program Director
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 617
6707 Democracy Boulevard
Bethesda, MD 20892-5458
Telephone: (301) 594-7717
Fax:  (301) 480-3510
Email: kusekj@extra.niddk.nih.gov 
or nybergl@extra.niddk.nih.gov
 
Direct inquiries regarding fiscal and administrative matters to:
 
Trude Hilliard
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Telephone:  (301) 594-8859
FAX:  (301) 480-3504
Email: hilliardt@extra.niddk.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance 
No 93.849.  Awards are made under authorization of the Public Health 
Service Act, Title IV, Part A (Public Law 78-410), as amended by Public 
Law 99-158, 42 USC 241 and 285) and administered under Public Health 
Service grants policies and Federal Regulations 42 CFR 52 and 45 CFR 
Part 74.  This program is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency review.
 
The Public Health Service strongly encourages all grant and contract 
recipients to provide a smoke-free work place and promote the non-use 
of all tobacco products.  In addition, Public Law 103-227, the Pro-
Children Act of 1994, prohibits smoking in certain facilities (or in 
some cases, any portion of a facility) in which regular or routine 
education, library, day care, health care, or early childhood 
development services are provided to children. This is consistent with 
the Public Health Service mission to protect and advance the physical 
and mental health of the American people.



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