To amend the Public Health Service Act to provide for educational activities and research with respect to women's pelvic floor health through the Centers for Disease Control and Prevention and the National Institutes of Health.

July 22, 2004

Mr. NETHERCUTT (for himself, Mrs. DAVIS of California, Mr. GERLACH, Mr. SESSIONS, and Mr. VITTER) introduced the following bill; which was referred to the Committee on Energy and Commerce

To amend the Public Health Service Act to provide for educational activities and research with respect to women's pelvic floor health through the Centers for Disease Control and Prevention and the National Institutes of Health.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the `Women's Pelvic Floor Health Education and Awareness Act'.

SEC. 2. FINDINGS.

The Congress finds as follows:

(1) Women's pelvic floor disorders are a group of common conditions that cause considerable disability and pain.

(2) Such disorders include bladder and bowel dysfunction, including incontinence. Another such disorder is pelvic organ prolapse, which involves a downward shift of uterine or vaginal structures from their normal positions. Often these conditions coexist.

(3) Women's pelvic floor disorders are extremely common and are barriers to healthy living.

(4) Women often suffer from a broad overlap of all pelvic floor disorders, usually experiencing several disorders simultaneously.

(5) Thirty percent of American women will suffer from a form of urinary incontinence.

(6) Eleven percent of women in the United States have surgery for urinary incontinence or pelvic organ prolapse during their lifetime, and close to one third will have a second surgery. Many more women are treated with nonsurgical techniques or remain untreated.

(7) Of the 3 million vaginal deliveries that occur each year in the United States, 900,000 women will develop symptomatic urinary incontinence and a smaller number will develop pelvic organ prolapse and bowel incontinence.

(8) An estimated $26.3 billion is spent annually to either treat or compensate for urinary incontinence.

(9) Many health care providers are not prepared to evaluate urinary pelvic floor disorders, including incontinence, and are unaware of treatment options.

(10) To address the public health threat posed by women's pelvic floor disorders, there is a need for the establishment of awareness and education programs directed at the public and primary-care providers, including the authorization of research focused on urinary incontinence and other pelvic floor disorders. Such programs will greatly help promote better care and treatment to those women afflicted with these disorders.

SEC. 3. EDUCATION REGARDING WOMEN'S PELVIC FLOOR DISORDERS.

(a) In General- Part P of title III of the Public Health Service Act (42 U.S.C. 280g et seq.) is amended by adding at the end the following section:

`SEC. 399O. EDUCATION REGARDING WOMEN'S PELVIC FLOOR DISORDERS.

`(a) In General- The Secretary, acting through the Administrator of the Health Resources and Services Administration and the Director of the Centers for Disease Control and Prevention, shall carry out a program to provide education regarding bladder and bowel dysfunction (including incontinence), pelvic organ prolapse, and other pelvic floor disorders to health professionals and the general public. Activities under such program shall be carried out directly by the Secretary and through awards of grants or contracts to States, political subdivisions of States, and other public or nonprofit private entities.

`(b) Certain Information- The Secretary shall ensure that education under subsection (a) includes, at a minimum--

`(1) information describing the prevalence of pelvic floor disorders in women; and

`(2) information regarding treatment options for such disorders.

`(c) Use of Internet- The Secretary shall ensure that the means through which education under subsection (a) is provided includes the posting of information on the Internet site of the Centers for Disease Control and Prevention. The Secretary shall ensure that, in the case of health professionals, such means includes means in addition to the posting of information on such site.

`(d) Authorization of Appropriations- For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2005 through 2009.'.

(b) Sense of Congress- It is the sense of the Congress that the Director of the Centers for Disease Control and Prevention should establish a national registry for surgical treatment of pelvic floor disorders, especially procedures using new technology.

SEC. 4. RESEARCH THROUGH NATIONAL INSTITUTES OF HEALTH.

(a) In General- Part B of title IV of the Public Health Service Act (42 U.S.C. 284 et seq.) is amended by adding at the end the following:

`SEC. 409J. WOMEN'S PELVIC FLOOR DISORDERS.

`(a) In General- The Directors of the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Child Health and Human Development shall expand and intensify the activities of such Institutes with respect to women's pelvic floor disorders, including proposals for research on such disorders that are developed independently of solicitations by the National Institutes of Health for research proposals.

`(b) Networks-

`(1) URINARY INCONTINENCE TREATMENT NETWORK- The Director of the National Institute of Diabetes and Digestive and Kidney Diseases, in consultation with the Director of the National Institute of Child Health and Human Development, shall provide for the continuing operation of the Urinary Incontinence Treatment Network. The Network was established pursuant to financial awards from such Institutes, and includes multiple continence treatment centers and a single biostatistical coordinating committee. The Director shall ensure that not fewer than eight such treatment centers are in operation and may provide for the establishment of additional treatment centers, subject to appropriations Acts.

`(2) CLINICAL TRIALS NETWORK FOR FEMALE PELVIC DISORDERS- The Director of the National Institute of Child Health and Human Development, in consultation with the Director of the National Institute of Diabetes and Digestive and Kidney Diseases, shall provide for the continuing operation of the Clinical Trials Network for Female Pelvic Disorders. The Network was established pursuant to financial awards from such Institutes, and includes multiple clinical sites and a single data coordinating committee. The Director shall ensure that not fewer than seven such clinical sites are in operation and may provide for the establishment of additional clinical sites, subject to appropriations Acts.

`(c) Peer Review- With respect to technical and scientific peer review under section 492, the Director of NIH shall ensure that groups that review research proposals under this section include urogynecologists. '.

(b) Sense of Congress-

(1) IN GENERAL- The Congress commends--

(A) the National Institute of Diabetes and Digestive and Kidney Diseases for its financial support of the Urinary Incontinence Treatment Network;

(B) the National Institute of Child Health and Human Development for its financial support of the Clinical Trials Network for Female Pelvic Disorders;

(C) the successful collaboration of such Institutes with respect to the Networks; and

(D) each of such Networks for the research it is conducting toward improving women's pelvic health.

(2) CERTAIN ACTIVITIES- It is the sense of the Congress that the Directors of the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Child Health and Human Development should--

(A) increase the size, scope, number, and funding for multidisciplinary research through centers and clinical sites of the Networks referred to in paragraph (1);

(B) encourage industry relationships in women's pelvic floor health related research;

(C) recruit established scientists from other relevant areas (such as cardiac or gastrointestinal physiology, cell signaling, biomechanical engineering, genomics, and proteomics) to apply their work to the urinary tract and incontinence by encouraging collaborative efforts between basic and clinical scientists;

(D) increase research funding for studies that use cellular and molecular techniques to examine the basic mechanisms of bladder and urethral interactions that create urinary continence and incontinence;

(E) support research to develop appropriate animal models of urinary incontinence;

(F) develop novel techniques (both invasive and noninvasive) for measuring neural, muscular (striated and smooth), and vascular function relating to pelvic floor health;

(G) identify risk factors for pelvic floor disorders and urinary incontinence related to childbirth and aging so that prevention measures and improved disease-specific treatment can be developed;

(H) initiate research to develop preventive and therapeutic approaches to urinary incontinence that are sensitive to gender, race, and culture, and develop the means of measuring outcomes for treatments in these varied settings;

(I) develop a national data registry and tissue bank of people suffering from incontinence to meet the needs of researchers for well-characterized tissue samples; and

(J) research the relationship between the anatomic changes of pelvic organ prolapse and the functional derangement's commonly seen in association with them, including voiding dysfunction and incontinence.

SEC. 5. INCLUSION OF WOMEN'S PELVIC FLOOR HEALTH IN NATIONAL CHILDREN'S STUDY.

The Director of the National Institute of Child Health and Human Development shall include women's pelvic floor health as one of the matters studied in the prospective cohort study regarding child health and human development that is being conducted under section 1004(b) of the Children's Health Act of 2000 (Public Law 106-310; 114 Stat. 1130) and is known as the National Children's Study.

SEC. 6. CONSULTATION.

In carrying out this Act, the Secretary of Health and Human Services shall consult with the American Urogynecologic Society and such other qualified professional and patient organizations as the Secretary determines to be appropriate.

END