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

Primary Purpose

Dysmenorrhea, Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Naproxen
Sponsored by
NorthShore University HealthSystem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea focused on measuring cross-organ sensitivity, bladder pain, NSAID, visceral pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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 painful bladder syndrome.

Sites / Locations

  • NorthShore University Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Primary Dysmenorrhea

Arm Description

We will look at the effects of naproxen 500mg use on pain starting just before and during menses.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 4, 2018
Last Updated
September 27, 2023
Sponsor
NorthShore University HealthSystem
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1. Study Identification

Unique Protocol Identification Number
NCT03697720
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 9, 2018 (Actual)
Primary Completion Date
November 23, 2020 (Actual)
Study Completion Date
September 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NorthShore University HealthSystem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea, Pain
Keywords
cross-organ sensitivity, bladder pain, NSAID, visceral pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary Dysmenorrhea
Arm Type
Experimental
Arm Description
We will look at the effects of naproxen 500mg use on pain starting just before and during menses.
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
Participants will take naproxen 500mg BID before and for the first 3 days of their period.
Primary Outcome Measure Information:
Title
Change in Menstrual Pain
Description
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.
Time Frame
6-8 months
Title
Change in Participant Bladder Pain Sensitivity From Baseline
Description
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.
Time Frame
6-8 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Tu, MD, MPH
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
Facility Information:
Facility Name
NorthShore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
7011011
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.
Results Reference
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PubMed Identifier
28888592
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.
Results Reference
background
PubMed Identifier
31870730
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.
Results Reference
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Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain

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