Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain



Status:Recruiting
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 45
Updated:10/7/2018
Start Date:May 9, 2018
End Date:May 1, 2021
Contact:Nicole Steiner
Email:pelvicpainresearch@northshore.org
Phone:847-570-2622

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The goal of this study is to see if optimized use of naproxen for treatment of dysmenorrhea
will improve pain report from baseline. In addition, we will determine whether cross-organ
influences from the uterus on bladder pain sensitivity change from baseline after reduced
menstrual pain experience over six months. Finally, a battery of quantitative sensory tests
and EEG measures of sensory sensitivity will be used to evaluate mechanisms associated with
improvements in menstrual and bladder pain.


Inclusion Criteria:

Reproductive-age women (age 18-45) with dysmenorrhea will be recruited. Cases will have: a)
average menstrual pain ≥ 5/10 (0=no pain and 10=the worst imaginable pain) on at least one
day during menses or during withdrawal uterine bleeding from cyclic OCs without
painkillers, b) menstrual pain in the region between the umbilicus and the perineum, above
the level of the inguinal ligament, and c) indication the participant has attempted to
resolve pain by medical means (including NSAIDs and/or OCPs). Participants who endorse
bladder symptoms (subclinical urgency, frequency, bladder pain) on the phone screen or
bladder symptoms will represent at least 50% of enrolled participants); those who do not
endorse bladder symptoms may be determined ineligible. They must not have a formal
urological diagnosis such as overactive bladder or painful bladder syndrome.

Exclusion Criteria:

Includes: a) presence of active pelvic or abdominal malignancies (primary or metastatic),
b) absence of regular menses (including current pregnancy, recent pregnancy, or active
breast feeding), c) active genitourinary infection in the last four weeks, d) unable to
read or comprehend the informed consent in English, e) unwilling to complete study
procedures, and f) presence of hypertension or risk for developing hypertension, g)
unwillingness to take naproxen and/or placebo, h) or contradictions to taking naproxen
(allergies, kidney disease, anemia, alcoholism, cardiovascular disease, stomach or
intestinal ulcer or abnormal liver function). Participants with a history of epilepsy will
not complete the visual unpleasantness task.
We found this trial at
1
site
Evanston, Illinois 60201
Principal Investigator: Frank Tu, MD, MPH
Phone: 847-570-2622
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Evanston, IL
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