Pelvic Floor Disorders Network
Workshop
A workshop on the Pelvic Floor Disorders Network was held on September
16, 2005 in conjunction with the American Urogynecologic Society meeting
in Atlanta, Georgia.
A summary of the workshop is provided below.
RFA: Pelvic Floor Disorders Network (PFDN)
The RFA (Request for Applications) was published in the NIH Guide on
August 17, 2005 and is available at http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-05-019.html.
RFA Corrections:
- Please note that these corrections are not official until the notices
announcing them are published in the NIH Guide.
- Although the RFA lists up to $125,000 as the limit for direct costs
from clinical site applicants, the correct figure is $175,000.
- Although the RFA states that the Principal Investigator must be
a urogynecologist, the correct statement is as follows:
The Principal Investigator should be able to make a substantive,
long-term commitment of effort to Network responsibilities. The clinical
investigators at each Clinical Site must include a urogynecologist
and a urologist with demonstrated training and experience in the diagnosis
and treatment of pelvic floor disorders in women. It is expected that
either a urologist or a urogynecologist will serve as the Principal
Investigator for a Clinical Site.
The following content summarizes questions discussed during a workshop
held on September 16, 2005 plus questions received through e-mail and
telephone contacts.
Question: |
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When will the content of this workshop be posted? |
Answer: |
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The content of the workshop held on September 16, 2005
will be posted by September 21, 2005. In addition, content will be
updated as new questions are received by program (Anne Weber), financial
(Cecilia Bruce), and review staff (Robert Stretch). |
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Question: |
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Does the Pelvic Floor Disorders Network support basic
science research as well as clinical trials? |
Answer: |
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Not at the current time. For the purposes of responding
to the RFA, the concept proposal should be a clinical research study |
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How many Clinical Sites will selected from the RFA applications? |
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As stated in the RFA (Part II - Full Text of Announcement,
Section I. Funding Opportunity Description, 1. Research Objectives,
paragraph 4), it is anticipated that 6 to 8 Clinical Sites
will be involved in the program, along with the Data Coordinating
Center. |
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Question: |
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There are currently 7 Clinical Sites in the Pelvic Floor
Disorders Network. Are all of the current clinical sites going to
respond to the RFA? |
Answer: |
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It is not currently known whether all of the current
Clinical Sites will respond to the RFA. This will only be known after
the application receipt deadline of December 19, 2005. |
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Question: |
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How many total applications do you expect to receive? |
Answer: |
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The total number of applications is unknown at this
time. It will be known only after the application receipt deadline
of December 19, 2005. |
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Question: |
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If current Clinical Sites do not submit an application
in response to the RFA or if their application is not selected for
funding, some subjects enrolled in PFDN studies will need follow-up
into the second cycle of the PFDN. If that is the case, what is the
source of funding for those sites that are not currently active Clinical
Sites of the PFDN? |
Answer: |
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The sites may request use of unobligated balances as
carryover, to complete follow-up for all subjects enrolled in PFDN
studies at that site. |
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Question: |
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Are the competing applications from current PFDN members
reviewed differently than applications from individuals/institutions
that are not current PFDN members? |
Answer: |
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No. The review process is the same for both competing
and new applications for the Clinical Sites and the Data Coordinating
Center. |
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Question: |
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Is there a minimum number of surgeries that an applicant
for a Clinical Site should perform to be considered for the Network? |
Answer: |
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No. There is no minimum number of surgeries required
of Clinical Site applicants. Minimum requirements for Clinical Site
applicants are listed in the RFA (Section IV, Application and Submission
Information, (6) Other Submission Requirements, under Minimum Requirements:
Clinical Site). Other requested information is listed in the same
section, specifically regarding clinical information under Clinical
Capabilities and Population Available for Clinical Trials. |
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Is it possible to submit an application that represents
a collaboration of different hospitals under the same or different
institutional name? |
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Yes. A single individual would still be identified as
Principal Investigator, and co-investigators would be identified at
all the different hospitals and/or institutions represented in the
collaboration. This can be a strong positive in an application because
the pool of potentially available subjects for study enrollment would
be larger within a collaboration than within a single hospital or
institution. However, the resources (infrastructure) provided by the
Network mechanism must be effectively and efficiently shared across
the different hospitals or institutions, and this presents challenges
requiring leadership and creativity to be successful. Therefore, it
is critically important that the application convincingly justify
the proposed collaboration with sufficiently detailed information
as to exactly how the collaboration will work. |
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Question: |
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Regarding the concept proposals in applications NOT
selected for funding, are those concept proposals considered for development
and implementation by the PFDN? |
Answer: |
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No. Concept proposals in applications NOT selected for
funding are not considered by the PFDN for development and implementation. |
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Question: |
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Does the PFDN consider proposals other than the concept
proposals in applications that are selected for funding? |
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Yes. While the PFDN will consider development and implementation
of the concept proposals in applications selected for funding, other
proposals are also considered through the established mechanisms for
proposing studies within the PFDN. |
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Do the applicants not selected for funding receive feedback
on their applications? |
Answer: |
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Yes. As is standard NIH procedure, all applicants will
receive summary statements containing feedback on their applications. |
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Question: |
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If an applicant is not selected for funding through
the RFA, is it possible to submit the concept proposal separately
for NIH funding? |
Answer: |
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Yes. If an applicant is not selected for funding as
part of the PFDN, the applicant can submit the concept proposal separately
for NIH funding through an appropriate mechanism such as an R01 application. |
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Question: |
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Is the NIH looking for any particular characteristics
of Clinical Sites, such as geographic location or racial/ethnic diversity? |
Answer: |
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The RFA lists detailed information that each applicant
should provide to describe the characteristics of their institution
that best meets the needs of the PFDN. It is possible that after all
the applications have received scientific review, program staff will
consider characteristics such as geographic location or racial/ethnic
diversity of the available study populations to determine if such
factors would meet particular needs of the PFDN and the public health
needs of women with pelvic floor disorders. Each applicant should
strive to present the unique strengths of their institution as comprehensively
as possible, to give scientific reviewers and program staff as much
information in supporting decisions for scoring and funding. |
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Question: |
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Can one institution submit more than one application
for a Clinical Site? |
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While the RFA does not specifically exclude the possibility
of one institution submitting more than one application for a Clinical
Site, it would not seem to be in the applicant's best interest to
do so. As noted in the RFA (Section V. Application Review Information,
2. Review and Selection Process, Clinical Site Applicants), each Clinical
Site application will be reviewed for the qualifications and commitment
of key personnel, protocols and procedures, and scientific review
of the concept proposal. Since the applicant should strive to present
the strongest concept proposal as well as the institution's strengths
and resources available to support PFDN studies in the most comprehensive
way possible, to split those resources between two applications would
place the applicant in the position of competing against himself or
herself through the two levels of review. |
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Question: |
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The RFA requires that a Clinical Site application include
a concept proposal plus information about the investigators and the
institution. How are these components of the Clinical Site application
valued or weighted in the scientific review? |
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Although weighting is not officially used in evaluating
the applications, applicants can consider that the Clinical Site applications
consist of two broad themes, which are valued roughly equally. One
theme is the scientific contribution to the PFDN from the investigators;
this is described in the application through the concept proposal,
and through the research experience and achievements (e.g., publications)
of the investigators. The second theme is the contribution to PFDN
activities by way of the pool of potential subjects in all the clinical
disciplines that care for women with pelvic floor disorders, and the
institutional resources that may be of value to the PFDN (e.g., special
expertise in pelvic floor imaging). |
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Question: |
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How will potential applicants who are not current members
of the PFDN know what Network studies are being done or planned? |
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Ongoing and planned PFDN studies are listed at the end
of the questions/answers. |
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Question: |
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How is the Advisory Board involved in the PFDN? |
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The Advisory Board has two major roles: (1) reviewing
scientific protocols for input as to study design, importance, and
feasibility; and (2) providing guidance to the Steering Committee
as to areas of high public health impact to address in designing studies
of pelvic floor disorders. |
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Does the concept proposal have to be a new study? |
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Yes, the concept proposal should describe a new study
that is not currently being performed by the applicant. Note that
the RFA (Section IV, Application and Submission Information, (6) Other
Submission Requirements, under Concept Proposal: Clinical Site) states
that randomized trials are the preferred study design although other
designs will be considered as appropriate to the research question;
in addition, the concept needs to be appropriate for the PFDN in that
it requires a multi-center design. |
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Is the concept proposal limited to studies of surgery? |
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No. The concept proposal is not limited to studies of
surgery. Under Section I. Funding Opportunity Description, 1. Research
Objectives, Scope, there are 4 bullet-points that describe broad examples
of research topics relevant to this RFA. Please note that this list
is not meant to be all-inclusive and prospective applicants are encouraged
to discuss their ideas for applications with program staff listed
under Section VII. Agency Contacts. |
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Question: |
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I am a Ph.D. who has been working on the urodynamics
of incontinence for years, as well as on the function of the pelvic
floor. Currently I am funded
What I am wondering is whether
there is a place for me in the PFDN or whether I should pursue my
current independent approach to the subject. |
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You may be eligible to respond as one of a team of investigators
from your institution, although the Principal Investigator of a Clinical
Site must be a clinician with demonstrated training and experience
in the diagnosis and treatment of pelvic floor disorders in women.
It is expected that either a urologist or a urogynecologist will serve
as the Principal Investigator for a Clinical Site. If your primary
area of interest lies in clinical trials in women with pelvic floor
disorders, and if you and colleagues at your institution would be
able to contribute substantial numbers of patients to clinical trial
enrollment, then I strongly encourage you to consider submitting an
application in response to the RFA. |
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Should the application include information on outpatients
and inpatients, or just inpatients? |
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Information on both inpatients and outpatients should be
provided. As noted in the RFA (Section IV, Application and Submission
Information, (6) Other Submission Requirements, under Population
Available for Clinical Trials: Clinical Site), information should
be provided for each year over the 2-year period of 2003-2004 in
tabular format, to specify the number of women patients, presented
separately for outpatient and inpatient settings and presented separately
for the following conditions:
- pelvic organ prolapse;
- urinary incontinence and other relevant lower urinary tract
disorders;
- fecal incontinence and other relevant lower gastrointestinal
tract disorders; and
- other pelvic floor disorders (specify).
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Is it an individual Principal Investigator OR an institution
that is limited to one application as a Clinical Site and one application
as the Data Coordinating Center? |
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Please refer to the RFA, the 9th bullet of
the Executive Summary, where "applicant" refers to the institutional
applicant:
"An applicant may apply for both a Clinical Site
and the Data Coordinating Center (DCC) grant; however, separate
applications with different principal investigators are required
for each, and the DCC application must include a specific plan for
maintaining the independent operation of each unit (e.g., confidentiality
of study-wide data).
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The RFA mentioned that matching isn't required. Will
applicants receive an advantage for providing matching funds? |
Answer: |
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The RFA states that Cost Sharing or Matching is "Not
Applicable," not that it is not required. |
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In the RFA, under Funds Available, is $3.4 million the
total commitment, or is that the yearly commitment? |
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The commitment of $3.4 million applies to Fiscal Year
(FY) 2006, and the participating Institutes and Centers intend to
commit approximately the same amount on a yearly basis for a project
period of 5 years. Please note that although the financial plans of
the Institutes and Centers provide support for this program, awards
pursuant to this funding opportunity are contingent upon the availability
of funds and the receipt of a sufficient number of meritorious applications. |
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I am a pelvic pain researcher, interested in the role
of pelvic muscles in pelvic pain syndromes. Is this an appropriate
topic to propose for the PFDN RFA? |
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As noted in the RFA (Section I. Funding Opportunity
Description, 1. Research Objectives, under the heading of Background),
the term "pelvic floor disorders" refers to a group of clinical
conditions that includes pelvic organ prolapse, urinary incontinence,
fecal incontinence, and other sensory and emptying abnormalities of
the lower urinary and gastrointestinal tracts. In addition, in the
same section under the heading of Scope, the scope includes clinical
problems in pelvic organ prolapse, urinary incontinence, and fecal
incontinence. Therefore, a proposal related to pelvic pain syndromes
would not be responsive to this RFA. |
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I am in private practice and I would like to propose
a study for the PFDN to consider developing and implementing. Would
I be able to participate in the PFDN in this way? |
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No, the RFA is not soliciting applications that consist
only of study proposals for the PFDN to consider developing and implementing.
The RFA invites applications from applicants (institutions with a
named Principal Investigator, co-investigators, research coordinator,
and other key personnel) that would participate in PFDN activities
by contributing to study design and enrollment of subjects in all
ongoing Network studies. |
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If a new site (rather than a continuing site) is selected
for funding as a Clinical Site in the PFDN, is the new site expected
to enroll subjects in ongoing PFDN studies? |
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Yes, all Clinical Sites (continuing and/or new) will
be expected to enroll subjects in ongoing PFDN studies. As noted in
the RFA (Section IV, Application and Submission Information, (6) Other
Submission Requirements, under Intent to Participate: Clinical Site),
sites are expected to participate in all Network studies (unless applicants
describe trials that conflict with ongoing Network studies as part
of their application for this RFA). |
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I am interested in pediatric pelvic floor disorders
such as imperforate anus. Is this an appropriate topic for the concept
proposal? |
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No. Pediatric conditions are not eligible for study
under this RFA. As noted in the RFA (Section I. Funding Opportunity
Description, 1. Research Objectives, in the paragraph after the bulleted
list under the heading of Scope), because the prevalence of pelvic
floor disorders is substantially greater in women than in men or children,
and because treatment of pelvic floor disorders in markedly different
in men or children compared to women, participation in the clinical
protocols planned under this initiative are restricted to adult women. |
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I am a researcher in London. Can I respond to this RFA? |
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No, applicants to this RFA are restricted to domestic
institutions. As noted in the RFA (Section III. Eligibility Information,
1. Eligible Applicants, 1.A. Eligible Institutions), the need for
continuous and active communication among sites dictates that only
institutions in the United States are eligible to apply. |
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Completed, Ongoing and Planned PFDN Studies.
Completed* Studies: NINE
*Data analyses/presentations/publications ongoing in some cases.
- CAPS: Childbirth and Pelvic Symptoms
- Cohort study of ~900 primiparous postpartum women, 400 after vaginal
delivery with anal sphincter laceration, 400 after vaginal delivery
without anal sphincter laceration, and 100 after cesarean delivery
without labor.
- Primary aim: to collect data at 6 weeks and 6 months postpartum
by telephone interview to describe the prevalence and incidence of
pelvic symptoms (fecal incontinence, urinary incontinence, etc.) in
primiparous women with and without anal sphincter laceration at vaginal
delivery, with cesarean delivery control group.
- Data collection completed in March 2005.
- *Data analyses ongoing.
- CAPS MRI-US
- Subset of ~230 women from the CAPS study population, 100 after vaginal
delivery with anal sphincter laceration, 100 after vaginal delivery
without anal sphincter laceration, and 30 after cesarean delivery
without labor.
- Primary aim: to collect data at 6 months postpartum to correlate
pelvic symptoms with physical examination and imaging of different
types.
- Data collection completed in March 2005.
- *Data analyses ongoing.
- Spanish Translation Protocol
- Study of 50 women, bilingual in English and Spanish, who completed
2 sets of validated questionnaires used in PFDN studies, one set in
English (original) and one set in Spanish as translated.
- Enrollment from March to May 2005.
- *Data analyses ongoing.
- Voiding Function in women with pelvic floor disorders.
- The primary aim of this observational analytic study is to describe
voiding function by symptoms and urodynamic findings in women with
prolapse with and without stress incontinence.
- Data from 160 CARE subjects (80 with true continence; 80 with potential
incontinence by urodynamic testing with prolapse reduction); 80 subjects
with prolapse and stress incontinence symptoms who are undergoing
abdominal sacral colpopexy (who would be eligible for CARE except
for stress incontinence symptoms); and 80 subjects with stress incontinence
and symptomatic prolapse who are undergoing urodynamic testing.
- Enrollment began in October 2004 and was completed in August 2005.
- *Data analyses are ongoing.
- HRQOL: Health-Related Quality of Life, or The CARE Adaptation Scale
and Life Orientation with Quality of Life Telephone Interview Study.
- Study of 88 women who completed baseline and follow-up interviews
of health-related quality of life measures.
- Conclusion: Condition-specific measures for pelvic floor disorders
are reliable and valid, including the Medical, Epidemiological and
Social Aspects of Aging (MESA) scale, Hunskaar Severity Measure, Pelvic
Floor Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire
(PFIQ), and the POP/UI Sexual Function Questionnaire (PISQ), as well
as general health status (SF-36) and life orientation (LOT-R) measures.
- Abstract presented at the Central Association of Obstetricians and
Gynecologists Annual Meeting in 2004; and manuscript published in
2005 in the American Journal of Obstetrics and Gynecology.
- Effects of Examination Technique Modifications on Pelvic Organ Prolapse
Quantification (POP-Q) Results.
- Cross-sectional study of 133 women who were examined for prolapse
using different modifications of the standardized staging system.
- Conclusion: Internal points are similar measured with and without
a speculum. Genital hiatus and perineal body should be measured at
straining. Maximal prolapse is best assessed with the patient in the
standing position.
- Abstract presented at 2 meetings in 2002 (Annual Meeting of the
International Urogynecologic Association; Annual Meeting of the American
Urogynecologic Society); and manuscript published in the International
Journal of Urogynecology in 2003.
- Correlation of Microtip Transducers and Water Perfusion Catheters.
- Randomized trial of 97 women with urodynamics performed with 2 sets
of catheters for comparison, either both water (n=18) or both microtip
(n=16) or one water and one microtip catheter (n=63).
- Conclusion: The different catheters produced pressures of different
values; therefore, the type of catheter used must be standardized
in clinical trials.
- Abstract presented at the Annual Meeting of the International Continence
Society in 2004; and manuscript in press at International Urogynecology
Journal.
- Development and Validation of the Modified Manchester Questionnaire.
- Study of 39 women who completed baseline and follow-up questionnaires,
including the Manchester Health Questionnaire (assessing symptoms
of fecal incontinence and other bowel disorders), modified to American
English, and the Fecal Incontinence Severity Index.
- Conclusion: The modified Manchester Health Questionnaire showed
good to excellent validity, internal consistency, and test-retest
reliability. It can be used in place of the original Manchester Health
Questionnaire for American populations.
- Abstract presented at the 2003 Annual Meeting of the American Urogynecologic
Society; and manuscript published in the journal Diseases of the
Colon and Rectum in 2005.
- A Randomized Trial of Colpopexy and Urinary Reduction Efforts (CARE):
Design and Methods.
- Abstract and manuscript describing the methods of the CARE trial.
- Abstract presented at 2 meetings (2002 Annual Meeting of the International
Urogynecologic Association, 2003 Annual Meeting of the Society of
Gynecologic Surgeons); and manuscript published in 2003 in the journal
Controlled Clinical Trials.
Ongoing Studies: Follow-up Only
- Colpopexy and Urinary Reduction Efforts: The CARE randomized surgical
trial
- Randomized surgical trial with 1:1 assignment to Burch or no
Burch for 322 women undergoing abdominal sacral colpopexy for prolapse.
- The primary aim is to determine the urinary outcomes for women
with prolapse undergoing abdominal sacrocolpopexy, without stress
incontinence symptoms at baseline, randomly assigned to Burch or
no Burch.
- Secondary outcomes include urodynamic testing and prediction of
outcomes; prolapse reduction and urodynamic results; quality of
life, sexual function, and complications.
- Although the original sample size was 480 women, enrollment was
closed on February 8, 2005 after the first interim analysis when
approximately half the sample, or 240 women, reached 3 months after
surgery and significant benefit was seen in Burch group. The final
sample was 322 subjects randomized.
- Follow-up for all subjects will continue for 2 years after surgery
(until approximately February 2007). (See E-CARE, below.)
Enrollment only at original PFDN sites
- E-CARE: Long-term effectiveness of abdominal sacral colpopexy for
the treatment of pelvic organ prolapse.
- The primary aim is to extend follow-up to the CARE study population
up to 10 years from surgery for long-term follow-up for symptoms
(urinary, prolapse, bowel, sexual function, quality of life) and
anatomic (prolapse) outcomes.
- Enrollment began in April 2004 when the subjects first enrolled
in CARE reached their 2-year postoperative visit. Enrollment will
be complete when the last subject enrolled in CARE reaches her 2-year
postoperative visit, or approximately February 2007. Data collection
should be completed approximately 8 years after enrollment, or 2015.
Ongoing Studies with Active Enrollment: TWO
- Pelvic Symptoms and Patient Satisfaction After Colpocleisis
- The primary aim of this cohort study is to describe pelvic symptoms,
particularly urinary function as to stress incontinence and voiding,
and patient satisfaction in 150 women undergoing colpocleisis for
advanced pelvic organ prolapse.
- There are three primary outcomes: (1) effect of colpocleisis on
anatomic support; (2) effects on quality of life and patient satisfaction;
and (3) urinary function (urinary incontinence and voiding dysfunction)
at one year after surgery. Secondary outcomes include complications
and patient preferences for urinary status.
- Enrollment began in July 2004 and is projected to take approximately
18 months, or until January 2006. Data collection will be complete
after one year of follow-up, or about January 2007.
- ATLAS: Ambulatory Treatments for Leakage Associated with Stress (Pessary
versus behavioral therapy for stress urinary incontinence)
- The primary aim of this randomized trial is to compare the effect
of pessary versus pelvic muscle exercises versus both in 450 women
with stress and mixed urinary incontinence.
- The primary outcome is the Patient Global Impression of Improvement
(PGI-I). Secondary outcomes include incontinence episodes by bladder
diary, symptoms, and validated questionnaires for condition-specific
and generic health-related quality of life.
- Enrollment began in July 2005, and is expected to take 2 years
to complete. Follow-up is planned for one year.
Planned Studies: FOUR
- Botox: Cystoscopic detrusor muscle injection with botulinum toxin
A for the treatment of detrusor overactivity incontinence.
- The primary aim of this randomized, placebo-controlled trial is
to compare the effect of cystoscopic injection of botulinum toxin
A (Botox) into the detrusor muscle of 210 women with medication-refractory
detrusor overactivity incontinence, versus placebo (saline).
- The primary outcome is the Patient Global Impression of Improvement
(PGI-I). Secondary outcomes include symptoms and validated questionnaires
for condition-specific and generic health-related quality of life.
- Enrollment is planned to begin in approximately January 2006,
and is expected to take 1 year to complete. Follow-up is planned
up to one year after the first Botox injection.
- Adaptation: Adaptive Behaviors Among Women with Pelvic Floor Disorders
- The primary aim of this cohort study is to develop and validate
an instrument to study adaptive behaviors in women with pelvic floor
disorders (pelvic organ prolapse, urinary incontinence, and fecal
incontinence).
- The first part of the study has been accomplished, i.e., working
with focus groups for refinement of an instrument developed by expert
consensus. The next step involves testing the instrument for validity
in clinical populations of 240 women with pelvic floor disorders,
and testing the instrument for sensitivity to change in 120 women
before and after surgical treatment for pelvic floor disorders.
- The validation protocol may be scheduled for implementation in
2006, depending on its priority relative to other protocols ready
for implementation. Enrollment of the clinical populations for validation
is anticipated to take 6-8 months, with follow-up after surgery
planned for 3-6 months.
- MAP: Muscle Assessment Protocol (Reliability and validity of pelvic
muscle assessment in women with pelvic floor dysfunction)
- The primary aim of this study is to compare pelvic muscle assessment
in 240 women with and without pelvic floor dysfunction by different
measurement techniques.
- Pelvic muscle assessment will be performed using two physical
examination techniques (Brink, Oxford), vaginal pressure by perineometer,
and force generated by pelvic muscle contraction using a speculum
device.
- 160 women with prolapse, in categories of 40 each with prolapse
only (no incontinence), stress incontinence, mixed incontinence,
and fecal incontinence; and 80 women without prolapse, in categories
of 20 each without prolapse or incontinence, stress incontinence,
mixed incontinence, and fecal incontinence.
- The protocol will be scheduled for implementation in Year 6 depending
on its priority relative to other protocols ready for implementation.
- PATH: Prolapse and Incontinence Combined Approach to Treatment
- The primary aim of this randomized surgical trial is to compare
functional and anatomic outcomes after surgery for advanced prolapse
and incontinence, using either the abdominal approach (abdominal
sacral colpopexy) or the vaginal approach (uterosacral ligament
suspension).
- The primary outcome is anatomic support at the apex, and anterior
and posterior vagina. Other outcomes will assess symptomatic resolution
after surgery and complications.
- Follow-up is planned for 5 years after the index surgery.
Pelvic Floor Disorders Network Members
Clinical Sites
Baylor College of Medicine
Principal Investigator: Dirk Kieback, MD
Johns Hopkins School of Medicine
Principal Investigator: Geoff Cundiff, MD
Loyola University
Principal Investigator: Linda Brubaker, MD, MS
University of Alabama at Birmingham
Principal Investigator: Holly Richter, MD, PhD
University of Iowa
Principal Investigator: Ingrid Nygaard, MD, MS
University of North Carolina at Chapel Hill
Principal Investigator: Anthony Visco, MD
University of Pittsburgh, Magee-Womens Hospital
Principal Investigator: Halina Zyczynski, MD
Data Coordinating Center
University of Michigan
Principal Investigator: Morton B. Brown, Ph.D.
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