Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain
Sponsor:
NorthShore University HealthSystem Research Institute
Collaborators:
Information provided by (Responsible Party):
Frank F. Tu，NorthShore University HealthSystem Research Institute
| Tracking Information | |||
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| First Submitted Date ICMJE | October 4, 2018 | ||
| First Posted Date ICMJE | October 5, 2018 | ||
| Last Update Posted Date | October 5, 2018 | ||
| Actual Study Start Date ICMJE | May 9, 2018 | ||
| Estimated Primary Completion Date | May 1, 2020 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Menstrual Pain[ Time Frame: 6-8 months ] Daily Diary data on menstrual pain-is it improved with the use of naproxen? Bladder Pain[ Time Frame: 6-8 months ] Experimental Bladder Pain sensitivity using a naturalistic paradigm-is it improved when menstrual pain is treated with naproxen? |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain |
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| Official Title ICMJE | Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain |
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| 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. |
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| Detailed Description | |||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 4 | ||
| Study Design ICMJE | Allocation: Intervention Model: Single Group Assignment Intervention Model Description: Masking: Interventional Masking Description: Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Recruiting | ||
| Estimated Enrollment ICMJE |
30 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | May 1, 2021 | ||
| Estimated Primary Completion Date | May 1, 2020 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: Reproductive-age women (age 18-45) with dysmenorrhea will be recruited. Cases will have: a) 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, b) menstrual pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament, and c) indication the participant has attempted to resolve pain by medical means (including NSAIDs and/or OCPs). Participants who endorse bladder symptoms (subclinical urgency, frequency, bladder pain) on the phone screen or bladder symptoms will represent at least 50% of enrolled participants); those who do not endorse bladder symptoms may be determined ineligible. They must not have a formal urological diagnosis such as overactive bladder or painful bladder syndrome. Exclusion Criteria: Includes: a) presence of active pelvic or abdominal malignancies (primary or metastatic), b) absence of regular menses (including current pregnancy, recent pregnancy, or active breast feeding), c) active genitourinary infection in the last four weeks, d) unable to read or comprehend the informed consent in English, e) unwilling to complete study procedures, and f) presence of hypertension or risk for developing hypertension, g) unwillingness to take naproxen and/or placebo, h) or contradictions to taking naproxen (allergies, kidney disease, anemia, alcoholism, cardiovascular disease, stomach or intestinal ulcer or abnormal liver function). Participants with a history of epilepsy will not complete the visual unpleasantness task. | ||
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Frank F. Tu，NorthShore University HealthSystem Research Institute | ||
| Study Sponsor ICMJE | NorthShore University HealthSystem Research Institute | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | NorthShore University HealthSystem Research Institute | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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