Chronic pelvic pain pelvic pain
Conditions
Interventions
Patients shall use the treatment device daily for 3 months after receiving the alternating magnetic field therapy device (treatment device). During use, the device may be used from once to four times
Sponsors
Kohzo Aisaka
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) premenopausal woman 2) Patients with chronic pelvic pain associated with endometriosis 3) Those with a maximum NRS score of 6 or higher for chronic pelvic pain 4) Those who agree to use appropriate contraception on a daily basis from the time consent is obtained and throughout the duration of the study.
Exclusion criteria
Exclusion criteria: 1) Persons participating in clinical trials or clinical studies of other drugs or medical devices 2) Those with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis 3) Persons with a history or complications of thyroid dysfunction 4) Patients with complications of pelvic infection or with a history of pelvic infection within 8 weeks prior to the visit. 5) Patients with a history of total hysterectomy or bilateral oophorectomy 6) Those determined to have significant irregular uterine bleeding or anovulatory bleeding complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: change from baseline in pain NRS score at 3 and 6 months after the start of use of the treatment device (percentage change, if necessary) Safety: adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| dysmenorrhea pelvic pain Pelvic tenderness Post instrumental pain score based on patient diary Incidence of device failure | — |
Contacts
Public ContactYamauchi Eisaku
R&D
Outcome results
None listed