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

NorthShore University HealthSystem

Status and phase

Completed

Phase 4

Conditions

Dysmenorrhea

Pain

Treatments

Drug: Naproxen

Study type

Interventional

Funder types

Other

Identifiers

NCT03697720

EH18-128

Details and patient eligibility

About

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.

Full description

Endometrial shedding during the menstrual cycle elicits profound changes in neuronal activity and cytokine concentrations 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 experience chronic pelvic pain (CPP) which may be in part due to cross-organ neural sensitization.

In this study we will establish whether prophylactic and adequate dosages of naproxen are capable of reducing menstrual pain more than *** use.

Enrollment

26 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Reproductive-age women (age 18-45) with dysmenorrhea
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
Menstrual pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament
Indication the participant has attempted to resolve pain by medical means (including NSAIDs and/or OCPs)

Exclusion criteria

Presence of active pelvic or abdominal malignancies (primary or metastatic)
Absence of regular menses (including current pregnancy, recent pregnancy, or active breast feeding)
Active genitourinary infection in the last four weeks
Unable to read or comprehend the informed consent in English
Unwilling to complete study procedures
Presence of hypertension or risk for developing hypertension
Unwillingness to take naproxen and/or placebo
Contradictions to taking naproxen (allergies, kidney disease, anemia, alcoholism, cardiovascular disease, stomach or intestinal ulcer or abnormal liver function)
Formal urological diagnosis such as overactive bladder or bladder pain syndrome.