Chronic Pain Risk Associated With Menstrual Period Pain
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Chronic Pain, Migraine Headaches, Women's Studies, Women's Studies, Urology, Urology, Endometriosis |
| Therapuetic Areas: | Musculoskeletal, Nephrology / Urology, Neurology, Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 3/21/2019 |
| Start Date: | July 2014 |
| End Date: | September 2025 |
| Contact: | Genevieve Roth |
| Email: | pelvicpainresearch@northshore.org |
| Phone: | 847-570-2622 |
Deciphering the Hormonal and Nociceptive Mechanisms Underlying Bladder Pain
The purpose of this study is to determine if some women with dysmenorrhea (painful periods)
are at higher future risk of developing chronic pelvic pain (CPP) and if oral contraceptives
(OC) can be used to reverse this chronic pain risk.
Investigators will examine whether dysmenorrhea produces CPP via repetitive cross organ
sensitization (COS) episodes. The use of cyclical OCs to eliminate dysmenorrhea is expected
to reduce COS and decrease the risk of developing CPP.
are at higher future risk of developing chronic pelvic pain (CPP) and if oral contraceptives
(OC) can be used to reverse this chronic pain risk.
Investigators will examine whether dysmenorrhea produces CPP via repetitive cross organ
sensitization (COS) episodes. The use of cyclical OCs to eliminate dysmenorrhea is expected
to reduce COS and decrease the risk of developing CPP.
Endometrial shedding during the menstrual cycle elicits profound changes in neuronal activity
and cytokines producing moderate to severe pelvic pain in more than 20% of reproductive-age
women. One out of every five of those women in turn will develop chronic pelvic pain (CPP),
yet women without dysmenorrhea rarely report CPP. CPP disorders such as irritable bowel
syndrome (IBS) and painful bladder syndrome (PBS) can cause severe, unrelenting pain due to a
lack of effective treatments.
This study consists of 2 aims.
Aim #1: To determine if dysmenorrhea with concomitant bladder pain sensitivity exhibits
neurophysiological features consistent with established CPP. Women with chronic pain or
dysmenorrhea without COS will be used as controls. Quantitative sensory testing (QST) and a
noninvasive bladder pain test that investigators validated previously be used to determine
whether impairments in descending inhibition and pelvic sensitivity are responsible for
vulnerability to COS in women with dysmenorrhea. EEG will be recorded to look for differences
in brain activity in response to sensory stimulation between participants cohorts.
Aim #2: To differentiate the individual contributions of circulating sex hormones and
repeated sensitizing events (painful menses) on descending and peripheral mechanisms of
bladder pain. The same QST/bladder pain measures studied in Aim #1 will be retested within
the dysmenorrhea+COS group following a one-year randomized trial of cyclical OCs vs.
continuous OCs vs. no treatment. An observational arm of PBS participants will receive
continuous OCs and serve as controls.
and cytokines producing moderate to severe pelvic pain in more than 20% of reproductive-age
women. One out of every five of those women in turn will develop chronic pelvic pain (CPP),
yet women without dysmenorrhea rarely report CPP. CPP disorders such as irritable bowel
syndrome (IBS) and painful bladder syndrome (PBS) can cause severe, unrelenting pain due to a
lack of effective treatments.
This study consists of 2 aims.
Aim #1: To determine if dysmenorrhea with concomitant bladder pain sensitivity exhibits
neurophysiological features consistent with established CPP. Women with chronic pain or
dysmenorrhea without COS will be used as controls. Quantitative sensory testing (QST) and a
noninvasive bladder pain test that investigators validated previously be used to determine
whether impairments in descending inhibition and pelvic sensitivity are responsible for
vulnerability to COS in women with dysmenorrhea. EEG will be recorded to look for differences
in brain activity in response to sensory stimulation between participants cohorts.
Aim #2: To differentiate the individual contributions of circulating sex hormones and
repeated sensitizing events (painful menses) on descending and peripheral mechanisms of
bladder pain. The same QST/bladder pain measures studied in Aim #1 will be retested within
the dysmenorrhea+COS group following a one-year randomized trial of cyclical OCs vs.
continuous OCs vs. no treatment. An observational arm of PBS participants will receive
continuous OCs and serve as controls.
Inclusion Criteria:
All
- Reproductive age women (18-45)
For dysmenorrhea and D+COS group only:
- Participants must have had regular (22-45 day) menstrual cycles over at least a two
month period preceding testing
Exclusion Criteria:
All
- presence of active pelvic or abdominal malignancies (primary or metastatic)
- active genitourinary infection in the last four weeks
- unable to read or comprehend the informed consent in English
- unwilling to undergo pelvic examination/testing
- presence of hypertension or risk for developing hypertension, and
For dysmenorrhea and D+COS group only:
- absence of regular menses (including current pregnancy, recent pregnancy, or active
breast feeding) unwilling to take either cyclic or combined OCs
- unwilling to withdraw from OCs for two months prior to the Aim #1 study visit.
We found this trial at
1
site
Evanston, Illinois 60201
Principal Investigator: Frank Tu, MD, MPH
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