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

Phase 4

Completed

• Conditions: Dysmenorrhea; Pain
• Interventions: Drug: Naproxen

• Registration Number: NCT03697720
• Lead Sponsor: NorthShore University HealthSystem

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.

Study Timeline

• Study Start: 2018-05-09
• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-04
• Study First Posted: 2018-10-05
• Primary Completion: 2020-11-23
• Status Verified: 2023-09
• Study Completion: 2023-09-27
• Results First Submitted: 2023-09-27
• Results First Submitted QC: 2023-09-27
• Last Update Submitted: 2023-09-27
• Results First Posted: 2023-10-18
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Primary Dysmenorrhea	Naproxen	We will look at the effects of naproxen 500mg use on pain starting just before and during menses.

Primary Outcome Measures

Name	Time	Method
Change in Participant Bladder Pain Sensitivity From Baseline	6-8 months	Score on a scale. Specifically, we used a Visual Analog Scale- 0 through 100 scale with 0 being no pain and 100 worst pain imaginable. Results from the visual analog scale (VAS) of the bladder filling test at the baseline and 6-8 mph followup visit will be compared to determine if naproxen treatment of menstrual pain affected bladder pain. Bladder pain ratings at first urge will be used at the outcome measure.
Change in Menstrual Pain	6-8 months	Score on a scale. Specifically, we used a Numeric Rating Scale (NRS)- 0 through 10 scale with 0 being no pain and 10 worst pain imaginable. Results for the worst menstrual pain score on an NRS from the 6-8 mth menstrual pain diary will be compared to baseline pretreatment diary worst pain score.

Trial Locations

Locations (1)

NorthShore University Health System; 🇺🇸 Evanston, Illinois, United States