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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03697720
• Other study ID #: EH18-128
• Status: Completed
• Phase: Phase 4
• Start date: May 9, 2018
• Est. completion date: September 27, 2023

Study information

• Verified date: September 2023
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 27, 2023
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysmenorrhea
• Pain

Intervention

Drug:
• Naproxen
Participants will take naproxen 500mg BID before and for the first 3 days of their period.

Locations

Country	Name	City	State
United States	NorthShore University Health System	Evanston	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Menstrual Pain	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.	6-8 months
Primary	Change in Participant Bladder Pain Sensitivity From Baseline	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.	6-8 months