Physical Activity Study

Overview

Status: Active, not recruiting
Keywords: physical activity , urinary incontinence , pelvic floor disorders
IRB Number: 00027546
Specialty: Urogyn and Pelvic Reconstructive Surgery
Sub Specialties:

Brief Summary

In two carefully designed case-control studies, we will compare cumulative lifetime and current physical activity between women with and without moderate or severe stress urinary incontinence and women with and without pelvic organ prolapse, using more comprehensive measures of physical activity relevant to pelvic floor outcomes than are available in existing cohorts. Leisure, household and occupational activities will be measured using validated questionnaires designed to assess current and cumulative lifetime activity in women. Based on our pilot work, we will supplement these questionnaires with loading and impact physical activities, which may affect pelvic floor support differently than do high metabolic activities. We will compare the volume of current and lifetime physical activity amongst women with and without pelvic organ prolapse and with and without stress urinary incontinence using both MET hours/week (the most widely used and traditionally accepted method) and a Strenuous Activity Index developed for this work. Additionally, we will establish a registry encompassing the cohort of women screened without urinary incontinence or pelvic organ prolapse to enable future prospective studies about the association between physical activity intensity and frequency and other risk factors on the incidence of these disorders.

Principal Investigator: Ingrid Nygaard
Department: Urogynecology
Co Investigator:

Contact Information

Name:Linda Griffen
Phone: 801-581-7038
Email: linda.griffen@hsc.utah.edu

Inclusion Criteria

Stress urinary incontinence case-control study Selection of case and control groups Cases and controls will be recruited from women attending primary care level clinics that participate in the Obstetrics and Gynecology Research Network. Case group: Moderate to severe urinary incontinence, stress predominant No pelvic organ prolapse • We estimate that 25-50% of women with moderate to severe stress incontinence will be ineligible based on pelvic examination. Control group: No to mild urinary incontinence No pelvic organ prolapse • We estimate that 25% of women with no to mild urinary incontinence will be ineligible based on pelvic examination. Additionally, the control group will be frequency matched to cases to ensure a similar distribution of age and body mass index. Age and body mass index are each significantly associated with both physical activity (negatively) and urinary incontinence (positively). We will monitor the sample periodically and target recruitment for controls accordingly. We will match on the following criteria: • Age (39-44, 45-49, 50-55, 56-60, 61-65 years) • Body mass index ( 18.5- 24.9, 25-29.9 and 30-34.9, 35-40 kg/m2) Pelvic organ prolapse case-control study Selection of case and control groups To ensure that we have a large enough sample of cases, we will recruit cases and controls from both the OGRN primary care clinics AND from tertiary care clinics. To decrease the risk of selection bias, cases recruited from urogynecology clinics will be frequency matched to controls attending tertiary care level clinics in specialties not expected to have different levels of physical activity. We will adjust for recruitment site in analyses. Case group: Pelvic organ prolapse No or mild urinary incontinence Recruited from the OGRN primary care clinics or University urogynecology clinics. • We estimate that 95% of women with no to mild urinary incontinence recruited from OGRN clinics and 5% recruited from urogynecology clinics will be ineligible based on pelvic examination (as all are routinely examined). Control group: No pelvic organ prolapse No to mild urinary incontinence Recruited from OGRN primary care clinics or from the following tertiary care clinics at the University of Utah: Dermatology, Otolaryngology and Ophthalmology. Note based on exclusion criteria that women may not be currently undergoing cancer treatment or be legally blind. These criteria were placed to minimize potential differences between women recruited from the tertiary care clinics. • We estimate that 25% of women with no to mild urinary incontinence will be ineligible based on pelvic examination. Controls will be frequency matched to cases to ensure a similar distribution of age, body mass index, and recruitment site (tertiary care vs community level clinic). Registry of non-affected women Women eligible to be in this registry include those recruited as controls, as well as women without urinary incontinence that, on pelvic examination, are found to have vaginal descent at the hymen. The latter group will complete the same instruments as participants in the case control studies.

Exclusion Criteria

Exclusion criteria for both case-control studies • Pregnant or within six months postpartum (note that pregnancy is excluded because including a large proportion of pregnant women would impact scientific validity but there are no safety concerns regarding pregnancy in this study; accordingly, we will question women about whether they are now or have recently been pregnant but will not confirm this with pregnancy testing) • Age < 39 or > 65 years • BMI < 18.5 kg/m2 (underweight) or > 40 kg/m2 (because this may impact physical activity because of joint pain or other sequelae of obesity) • Prior surgical treatment for prolapse or incontinence (because this may impact subsequent physical activity) • Not ambulatory (defined as able to walk independently without aids) • Major medical or surgical problem precluding exercise for the last 12 months • Medical conditions associated with incontinence or low physical activity (diabetes, neurologic disorders such as multiple sclerosis, spinal cord injury, or stroke, rheumatoid arthritis, blind, radical hysterectomy or pelvic irradiation) • Current treatment for cancer • Unable to complete questionnaires - Abdominal or pelvic mass greater than 16 week size on abdominal exam. The age range 39-65 years was chosen to reflect the population that is both likely to have stress urinary incontinence and pelvic organ prolapse AND still be of an age likely to engage in physical activity. Additionally, this age range mimics that of women included in the Lifetime PHysical ACtivity Questionnaire (LPAQ) validation study.