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:
  When will the content of this workshop be posted?
Answer:
  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).
   
Question:
  Does the Pelvic Floor Disorders Network support basic science research as well as clinical trials?
Answer:
  Not at the current time. For the purposes of responding to the RFA, the concept proposal should be a clinical research study
   
Question:
  How many Clinical Sites will selected from the RFA applications?
Answer:
  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.
   
Question:
  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:
  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.
   
Question:
  How many total applications do you expect to receive?
Answer:
  The total number of applications is unknown at this time. It will be known only after the application receipt deadline of December 19, 2005.
   
Question:
  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:
  The sites may request use of unobligated balances as carryover, to complete follow-up for all subjects enrolled in PFDN studies at that site.
   
Question:
  Are the competing applications from current PFDN members reviewed differently than applications from individuals/institutions that are not current PFDN members?
Answer:
  No. The review process is the same for both competing and new applications for the Clinical Sites and the Data Coordinating Center.
   
Question:
  Is there a minimum number of surgeries that an applicant for a Clinical Site should perform to be considered for the Network?
Answer:
  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.
   
Question:
  Is it possible to submit an application that represents a collaboration of different hospitals under the same or different institutional name?
Answer:
  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.
   
Question:
  Regarding the concept proposals in applications NOT selected for funding, are those concept proposals considered for development and implementation by the PFDN?
Answer:
  No. Concept proposals in applications NOT selected for funding are not considered by the PFDN for development and implementation.
   
Question:
  Does the PFDN consider proposals other than the concept proposals in applications that are selected for funding?
Answer:
  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.
   
Question:
  Do the applicants not selected for funding receive feedback on their applications?
Answer:
  Yes. As is standard NIH procedure, all applicants will receive summary statements containing feedback on their applications.
   
Question:
  If an applicant is not selected for funding through the RFA, is it possible to submit the concept proposal separately for NIH funding?
Answer:
  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.
   
Question:
  Is the NIH looking for any particular characteristics of Clinical Sites, such as geographic location or racial/ethnic diversity?
Answer:
  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.
   
Question:
  Can one institution submit more than one application for a Clinical Site?
Answer:
  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.
   
Question:
  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?
Answer:
  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).
   
Question:
  How will potential applicants who are not current members of the PFDN know what Network studies are being done or planned?
Answer:
  Ongoing and planned PFDN studies are listed at the end of the questions/answers.
   
Question:
  How is the Advisory Board involved in the PFDN?
Answer:
  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.
   
Question:
  Does the concept proposal have to be a new study?
Answer:
  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.
   
Question:
  Is the concept proposal limited to studies of surgery?
Answer:
  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.
   
Question:
  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.
Answer:
  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.
   
Question:
  Should the application include information on outpatients and inpatients, or just inpatients?
Answer:
 

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:

  1. pelvic organ prolapse;
  2. urinary incontinence and other relevant lower urinary tract disorders;
  3. fecal incontinence and other relevant lower gastrointestinal tract disorders; and
  4. other pelvic floor disorders (specify).
   
Question:
  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?
Answer:
  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).
   
Question:
  The RFA mentioned that matching isn't required. Will applicants receive an advantage for providing matching funds?
Answer:
  The RFA states that Cost Sharing or Matching is "Not Applicable," not that it is not required.
   
Question:
  In the RFA, under Funds Available, is $3.4 million the total commitment, or is that the yearly commitment?
Answer:
  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.
   
Question:
  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?
Answer:
  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.
   
Question:
  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?
Answer:
  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.
   
Question:
  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?
Answer:
  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).
   
Question:
  I am interested in pediatric pelvic floor disorders such as imperforate anus. Is this an appropriate topic for the concept proposal?
Answer:
  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.
   
Question:
  I am a researcher in London. Can I respond to this RFA?
Answer:
  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.
   

Completed, Ongoing and Planned PFDN Studies.

Completed* Studies: NINE

*Data analyses/presentations/publications ongoing in some cases.

  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.


  6. 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.


  7. 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.

  8. 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.

  9. 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

  1. 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

  1. 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

  1. 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.


  2. 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

  1. 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.


  2. 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.


  3. 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.


  4. 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.