Clinical trial NCT03697720: Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain
Official title: Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dysmenorrhea
Pain
Keywords: cross-organ sensitivity
bladder pain
NSAID
visceral pain
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Menstrual Pain
timeFrame: 6-8 months
measure: Change in Participant Bladder Pain Sensitivity From Baseline
timeFrame: 6-8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Frank Tu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan WY, Dawood MY, Fuchs F. Prostaglandins in primary dysmenorrhea. Comparison of prophylactic and nonprophylactic treatment with ibuprofen and use of oral contraceptives. Am J Med. 1981 Mar;70(3):535-41. doi: 10.1016/0002-9343(81)90576-3.
citation: Oladosu FA, Tu FF, Hellman KM. Nonsteroidal antiinflammatory drug resistance in dysmenorrhea: epidemiology, causes, and treatment. Am J Obstet Gynecol. 2018 Apr;218(4):390-400. doi: 10.1016/j.ajog.2017.08.108. Epub 2017 Sep 6.
citation: Tu FF, Datta A, Atashroo D, Senapati S, Roth G, Clauw DJ, Hellman KM. Clinical profile of comorbid dysmenorrhea and bladder sensitivity: a cross-sectional analysis. Am J Obstet Gynecol. 2020 Jun;222(6):594.e1-594.e11. doi: 10.1016/j.ajog.2019.12.010. Epub 2019 Dec 20.