Dysmenorrhea in Women With Crohn's Disease and Ulcerative Colitis

University of Wisconsin (UW)

Status

Completed

Conditions

Ulcerative Colitis

Crohn's Disease

Treatments

Other: Questionnaire Only

Study type

Observational

Funder types

Other

Identifiers

NCT02274714

MDQ

Details and patient eligibility

About

This case-control study will screen for dysmenorrhea and assess severity of menstrual symptoms in menstruating women with CD and UC compared with healthy age-matched controls. IBD activity will be characterized using previously validated clinical disease activity indices. General and health-related quality of life will be assessed using validated measures.

Full description

Given the prior studies in IBD and corollary studies in IBS, we hypothesize that dysmenorrhea is more common in menstruating women with CD and UC than in the general population. Furthermore, we hypothesize that CD and UC activity as measured by non-invasive disease activity scores will be higher, and quality of life lower in women with both CD and UC and dysmenorrhea. As deciphering this complex relationship may avoid unnecessary testing or changes in therapy, we propose to characterize and compare the prevalence of dysmenorrhea in menstruating women with and without CD and UC. Furthermore, we will compare CD and UC activity and IBD-related quality of life in women with and without dysmenorrhea in a population of menstruating women with IBD. Lastly, we will compare general quality of life in women with and without either form of IBD and dysmenorrhea.

Enrollment

203 patients

Sex

Female

Ages

18 to 48 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria.

Cases: Women aged 18-48 years with regular menstrual cycles AND with an established diagnosis of CD or UC involving the small bowel, colon or both will be eligible for the study. Cases may be using oral, transdermal, or intravaginal hormonal contraception for the purpose of birth control. Regular menstrual cycles will be defined as cycles ranging from of 24 to 35 days and lasting 4 to 6 days for 3 consecutive months prior to study entry. Diagnosis of CD or UC must be made by an accredited physician on the basis of typical clinical symptoms and endoscopic, histologic, and/or radiographic findings
Controls: Women aged 18-48 years with regular menstrual cycles and without a diagnosis of CD will qualify for the study. Controls may be using oral, transdermal or intravaginal hormonal contraception for the purpose of birth control. Regular menstrual cycles will be defined as described above. Frequency matching will be used to ensure controls are aged-matched.

Exclusion criteria include

Inability to give written informed consent
Pregnancy or breast feeding
Primary or secondary amenorrhea
Recent (within past 3 months) abdominal or gynecologic surgery
Current or recent use (within past 3 months) of intradermal
Injectable or intrauterine (hormonal or non-hormonal) contraception
Less than 3 months post-partum, or post-menopausal status
Women within 3 years of menarche will also be excluded due to the high prevalence of anovulatory cycles during this period
Women will be excluded if they have a diagnosis of irritable bowel syndrome, or other functional bowel disorder
Women with established endometriosis, pelvic inflammatory disease or other significant gynecologic pathology will also be excluded
All participants with major medical issues, besides CD, as judged by the research team, will be excluded
Major medical issues include significant disease of any organ system, such as heart failure, emphysema, or kidney failure