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NIH Research Awards

Current Grants

Specialized Center of Research (SCOR) on Sex an Gender Factors Affecting Women' s Health; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Principal Investigator: Jeanette S. Brown, MD; Co- Principal Investigator: Tom Lue, MD.
This program project, the UCSF SCOR on lower urinary tract function in women will provide the organizational structure to further develop and support multi-disciplinary, collaborative research projects from both basic and clinical investigators. The UCSF SCOR will also strengthen a productive existing program of multidisciplinary research including researchers from the Departments of Obstetrics, Gynecology, and Reproductive Sciences, Urology, Epidemiology, and Family Medicine. Working as a single administrative unit, the UCSF SCOR will provide an efficient mechanism for development and completion of collaborative, multi-institutional, multi-disciplinary research, enhancing the productivity of our group of investigators. This "bench to bedside" collaborative research paradigm will facilitate direct translation of scientific results to improved patient care. (RFA-OD-02-002; 10/02 - 9/07)

Urinary Incontinence: Reproductive/Hormonal Factors; NIDDK. Principal Investigator: David Thom, MD, PhD; Co-Investigators: Steven van den Eeden, PhD and Jeanette S. Brown, MD.
To determine the association between specific childbirth variables, hysterectomy, hormone use and subsequent urinary incontinence. 2100 ethnically diverse women ages 40 to 69 will be enrolled. Incontinence will be assessed by a detailed in-person interview and specific potential risk factors associated with parturition, including vaginal delivery, use of forceps, episiotomy, and infant birth weight will be abstracted from the labor and delivery records. (RO1-DDK5335; 11/98-10/02)

Urinary Incontinence: Reproductive/Hormonal Risk Factors; NIDDK. Principal Investigator: David H. Thom, MD, PhD; Co-Investigators: Steven van den Eeden, PhD and Jeanette S. Brown, MD.
This study will ascertain the incidence of and risk factors for urinary incontinence in a well-characterized cohort of 2100 racially and ethnically diverse middle-aged and older women. Risk factors of special interest include parturition variables, hormones, pelvic surgeries, pelvic organ prolapse, obesity, urinary tract infections, and physical activity. Additional studies will be performed to assess the relationship between serum estradiol levels and urinary incontinence in a nested case-control study and to compare utilization of medical services and costs of care for women with urinary incontinence to continent women. (SCOR R01; 10/02 - 9/07)

Reproductive Risk Factors for Pelvic Organ Prolapse; National Institute of Child Health and Human Development (NICHD). Principal Investigator: Jeanette S. Brown, MD; Co-Investigator: David Thom, MD, PhD.
A 1100 woman population-based sample will be objectively assessed for pelvic organ prolapse to determine the prevalence of prolapse by vaginal segment and severity (Stage I-IV), and age group. The ethnic diversity of study subjects will allow comparison of prevalence estimates between major ethnic groups. Additional aims are to determine the association between specific aspects of parturition and development of prolapse in later life; to ascertain the association between hysterectomy (type and indication) and subsequent prolapse; to identify other potential risk factors for prolapse, especially those that are preventable or modifiable; and to describe the associations of pelvic organ prolapse with urinary and fecal incontinence. Identification of risk factors for prolapse will help guide the development of preventive intervention trials to test the efficacy of modifying risk factors for pelvic organ prolapse. (R01- HD-41134; 9/01-8/05)

Diabetes Prevention Program (DPP) Urinary Incontinence Study; NIDDK. Principal Investigator: Jeanette S. Brown, MD.
The DPP is a 3234 participant randomized trial of interventions to prevent the development of diabetes in adults with glucose intolerance. An ancillary urinary incontinence study will be implemented at the end-of-study visit beginning January 2002. The primary objective is to determine if glucose intolerance, like frank diabetes is a risk factor for incontinence. Most importantly, we will be able to determine if interventions that reduce the risk of developing diabetes also reduce the risk of developing incontinence. The DPP has been funded for long-term follow-up of the cohort. The urinary incontinence study has been approved to repeat incontinence measures in the long-term cohort study. (5U01; DK 48489; 7/01-6/02)

Action for Health in Diabetes (Look AHEAD): Urinary Incontinence Study; NIDDK. Principal Investigator: Jeanette S. Brown, MD.
The Look AHEAD is a randomized trial to test the effect of weight reduction vs. control on cardiovascular events in 5000 obese participants with type 2 diabetes. An incontinence study has been approved and funded to be implemented at baseline and for annual evaluations (approximately 12 years of follow-up). The primary objective is to determine if weight loss reduces the development or severity of urinary incontinence among obese type-2 diabetics. Most importantly, we will be able to determine if interventions that reduce weight and potentially changes in health risk and disease progression also reduce the risk of developing incontinence. (NIDDK Cooperative Agreement DK 57136; 9/01-8/06)

Diabetes and Urinary Incontinence. K-24 Mid-career Investigator Award in Patient Oriented Research; NIDDK. Principal Investigator: Jeanette S. Brown, MD.
The study will determine among women with diabetes: prevalence and incidence of urinary incontinence by type (urge, stress, and mixed) and severity, both overall and by race; risk factors associated with incontinence, especially aspects of diabetes severity (duration, treatment, glycemic control, presence of microvascular complications including retinopathy, nephropathy and neuropathy) that are associated with greater risk or severity of urinary incontinence; and whether interventions including glycemic control or weight reduction prevent or reduce severity of urinary incontinence among women with diabetes. Questionnaire, laboratory, and outcome data from a triad of diabetes studies that include women with impaired glucose tolerance, type 2 and type 1 diabetes and 2 population-based cohort studies that include women with and without diabetes will be analyzed. (PA-98-053; 10/02-5/06)

Epidemiology of Diabetes Interventions & Complications (EDIC), Uro-EDIC Study. Principal Investigator: Jeanette S. Brown, MD.
In April 2001, representatives from the NIDDK Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) and the Division of Diabetes, Endocrinology and Metabolic Diseases (DEM) convened a meeting of experts in sexual function, urinary incontinence (Dr. Brown, Chair), and urinary tract infections. The meeting included discussion of the current state of knowledge, gaps in knowledge, and future directions for research in urologic complications among diabetics. The group identified the EDIC Study as an important cohort study to develop an ancillary study proposal to determine urologic outcomes in men and women with type 1 diabetes. A proposal for the Uro-EDIC has been approved from the EDIC study and the study will begin September 2002.

Diabetes: Lower Urinary Tract Dysfunction and Infections; NIDDK. Principal Investigator: Jeanette S. Brown, MD; Co-Investigators: Steven van den Eeden, PhD and David H. Thom, MD, PhD.
The proposed longitudinal follow-up of the RRISK cohort, including 400 women with type 2 diabetes, offers a unique and efficient opportunity to understand the natural history and possible mechanisms for lower urinary tract dysfunction and urinary tract infections in women with and without type 2 diabetes. Lower urinary tract dysfunction will be precisely evaluated using postvoid residual, uroflow, and urodynamic testing, as well as validated questionnaires, diaries, and laboratory data. A better understanding of risk factors for and pathogenesis of lower urinary tract dysfunction and urinary tract infections will help guide the development of preventive interventions, especially for women at higher risk because of type 2 diabetes. (SCOR R01; 10/02 - 9/07)

Economic Analysis of the Program to Reduce Incontinence by Diet and Exercise (E-PRIDE) (1 R01 DK070196-01A1). To evaluate the costs, health-related quality of life and cost-effectiveness of the diet and exercise program compared to a standard informational pamphlet on frequency of urinary incontinence. E-PRIDE is an ancillary study to the PRIDE, a 330 participant randomized clinical trial evaluating weight reduction to treat obese women with urinary incontinence. The E-PRIDE will conduct cost-utility analysis of randomization to a weight reduction program versus control to treat incontinence. (PI: Subak, LL; 7/1/05–7/31/08)

Program to Reduce Incontinence by Diet and Exercise (PRIDE) (1 U01 DK067860-01). To determine the effect of a diet and exercise program on urinary incontinence among overweight and obese women with incontinence. PRIDE is a 330 participant randomized clinical trial evaluating weight reduction to treat obese women with urinary incontinence. Women will be randomized to a 6 month weight reduction program or usual care group without weight reduction followed by a second randomization to an enhanced or a standard weight maintenance strategy and 18 month follow-up. This study will determine whether randomization to a behavioral weight control program results in greater improvement in continence compared to usual care and identify women most likely to experience improved continence after weight reduction. We will also evaluate an enhanced, motivationally-focused weight maintenance program compared to a standard, skill-based maintenance program or usual care for weight loss, sustained improvement in continence, and improvement in quality of life. UCSF will be the Coordinating Center for the two site trial. (PI: PI: Subak, LL; 8/1/03–7/31/08)

Molecular mechanisms of female stress urinary incontinence; NIDDK. Principal Investigator: Tom F. Lue; Co-Investigator: Ching S. Lin, PhD.
The major goal of this project is to investigate the effect of birth trauma, ovariectomy and aging on the female continence mechanism. (R01 DK 51374; 12/98-11/02)

Regeneration of functional smooth muscle tissue; NIDDK. Principal Investigator: Emil A. Tanagho, MD, Co-Investigator: Tom F. Lue.
The major goal of this project is to investigate the cellular and molecular mechanisms of growth factor mediated regeneration of acellular bladder matrix using both in vitro and in vivo models and its potential clinical use. (R01 DK 51101; 1/01-12/04)

Urinary Incontinence: Molecular Mechanism and Matrix-based therapy; NIDDK. Principal Investigator: Tom Lue, MD; Co- Investigators: Ching Lin, PhD and Emil Tanagho, MD.
This study will identify the genes that are associated with stress urinary incontinence in a rat model resulting from pregnancy/delivery, birth trauma and ovariectomy. In addition, the researchers will identify growth factors that can enhance angiogenesis, neural and muscular growth in a novel in vitro system. Once the ideal growth factor combinations are identified, the researchers will explore the potential of curing stress urinary incontinence with acellular matrix treated with and without growth factors. (SCOR R01; 10/02 - 9/07)

Completed Grants

Prevalence, incidence, and associated risk factors for urinary incontinence; National Institute of Aging, Mentored Clinical Scientist Development Award; NIDDK. Principal Investigator: Jeanette S. Brown, MD.
To determine risk factors for urinary incontinence and to test the effectiveness of hormone therapy for urinary incontinence in elderly women. The identification of risk factors will guide the development of randomized trials of the efficacy of preventable or modifiable factors. The research on hormone replacement therapy will provide definitive data on the efficacy of hormone therapy to prevent the development of urinary incontinence and as treatment for incontinence. (KO8-AG 00710; 5/97-5/01)


Women's Reproductive Health Research Career Development (WRHR); NICHD/OWHR. Scholar: Leslee L. Subak, MD.
The purpose of the UCSF WRHR is to recruit and prepare outstanding candidates to acquire the new skills they will need to achieve our principal mission: to promote health and prevent disease in women by expanding the pool of well-trained, imaginative, productive investigators in the field of women's reproductive health. The primary focus of Dr. Subak's research is investigating the clinical effectiveness and cost-effectiveness of medical care for female urinary incontinence and pelvic floor disorders. Understanding the impact of incontinence symptoms and costs on women's lives and the effectiveness, costs, and cost-effectiveness of treatment will facilitate the development of evidence-based management guidelines, with the long-term goal of improving quality of life for women with incontinence and pelvic floor disorders. (K12 HD01262-02; 1/99-12/03)

Stress urinary incontinence: costs, utilities and cost-effectiveness of treatment; ancillary study to the Urinary Incontinence Treatment Network (UITN); NIDDK. Principal Investigator: Leslee L. Subak, MD.
The UITN is a 500 participant randomized clinical trial to compare Burch and sling procedures to treat women with stress incontinence. A study has been approved and funded to evaluate the costs of routine care and treatment for urinary incontinence. In addition, we will quantify utilities for incontinence health states, willingness-to-pay for improvement in incontinence, and the cost-utility of the two treatment strategies. (U01 DK58229; 7/01-6/06)

 

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