Trial Outcomes & Findings for Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain (NCT NCT03697720)

Last Updated: 2023-10-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

6-8 months

Results posted on

2023-10-18

Participant Flow

Participants were recruited between April 2018 and December 2019 from our registry and other studies.

Participant milestones

Participant milestones
Measure	Primary Dysmenorrhea We will look at the effects of naproxen 500mg use on pain starting just before and during menses. Naproxen: Participants will take naproxen 500mg BID before and for the first 3 days of their period.
Overall Study STARTED	26
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Primary Dysmenorrhea We will look at the effects of naproxen 500mg use on pain starting just before and during menses. Naproxen: Participants will take naproxen 500mg BID before and for the first 3 days of their period.
Overall Study Lost to Follow-up	7

Baseline Characteristics

3 participants did not complete baseline visits to measure bladder pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Primary Dysmenorrhea n=26 Participants We will look at the effects of naproxen 500mg use on pain starting just before and during menses. Naproxen: Participants will take naproxen 500mg BID before and for the first 3 days of their period.
Age, Continuous	24.5 years STANDARD_DEVIATION 6.3 • n=26 Participants
Sex: Female, Male Female	26 Participants n=26 Participants
Sex: Female, Male Male	0 Participants n=26 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=26 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=26 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=26 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=26 Participants
Race (NIH/OMB) Asian	2 Participants n=26 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=26 Participants
Race (NIH/OMB) Black or African American	5 Participants n=26 Participants
Race (NIH/OMB) White	17 Participants n=26 Participants
Race (NIH/OMB) More than one race	2 Participants n=26 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=26 Participants
Menstrual Pain	6.0 Numerical rating scale STANDARD_DEVIATION 2.0 • n=26 Participants
Bladder Pain	16.5 Visual Analog Scale 0-100 STANDARD_DEVIATION 16.3 • n=23 Participants • 3 participants did not complete baseline visits to measure bladder pain

PRIMARY outcome

Timeframe: 6-8 months

Population: Some participant data were missing due to attrition

Outcome measures

Outcome measures
Measure	Primary Dysmenorrhea n=19 Participants We will look at the effects of naproxen 500mg use on pain starting just before and during menses. Naproxen: Participants will take naproxen 500mg BID before and for the first 3 days of their period.
Change in Menstrual Pain	4.1 score on a scale Standard Deviation 2.4

PRIMARY outcome

Timeframe: 6-8 months

Population: Some participant data were missing due to attrition.

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.

Outcome measures

Outcome measures
Measure	Primary Dysmenorrhea n=17 Participants We will look at the effects of naproxen 500mg use on pain starting just before and during menses. Naproxen: Participants will take naproxen 500mg BID before and for the first 3 days of their period.
Change in Participant Bladder Pain Sensitivity From Baseline	10.7 score on a scale Standard Deviation 10.6

Adverse Events

Primary Dysmenorrhea

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Primary Dysmenorrhea n=26 participants at risk We will look at the effects of naproxen 500mg use on pain starting just before and during menses. Naproxen: Participants will take naproxen 500mg BID before and for the first 3 days of their period.
Gastrointestinal disorders Dyspepsia grade 1	3.8% 1/26 • Number of events 1 • 6 months Participants were asked to verbally relay any AEs they had experienced during the trial at follow-up. Please note, all-cause mortality or serious \& other AEs were not formally queried, but we did monitor for them.

Additional Information

Kevin Hellman, Research Associate Professor

NorthShore University HealthSystem

Phone: 847-570-2622

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place