Dysmenorrhea
Conditions
Keywords
Livia TENS, safety and efficacy, menstruating women
Brief summary
This is a randomized, controlled, multi-center, single-arm, crossover, double-blind clinical study assessing the Livia Transcutaneous Electrical Nerve Stimulation (TENS) in women suffering from dysmenorrhea. The study will be conducted at community clinics. Advertisement will be used to publish and promote recruitment. The study will include 3 visits: Screening visit and two consecutive visits each one after monthly menstrual period. Treatment will be self-administrated and during the study, the subjects will be requested to complete home diaries.
Interventions
DEVICELivia
Livia® Transcutaneous Electrical Nerve Stimulation (TENS) is a novel pain management device for women suffering from dysmenorrhea
Sponsors
iPulse Medical Ltd. (Livia)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Women between the age 18 to 45 years 2. Women reporting painful menstruation during the last 3 menstrual cycles. 3. Pain VAS score of at least 60 based on previous menstrual cycle 4. Subject is willing and able to comply with the study protocol and provide written informed consent to participate in the study. 5. Subject must agree to consistently use effective contraception throughout the study. (Subject not treated with oral contraception should use any contraception other than oral).
Exclusion criteria
1. Participation in any other investigational study within 30 days prior and/or at the date of subject consent. 2. Woman with a significant medical condition such as: cancer, diabetes (Type I and II), irritable bowel disease IBD, immunodeficiency, autoimmune disease, etc. that in the investigator opinion, participation in the study would place the patient at an unacceptable risk. 3. Pregnant woman 4. A woman who is diagnosed with secondary dysmenorrhea associated with uterine myomas, endometriosis, adenomyosis, etc. 5. A woman who has cardiac condition with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference between the reported Visual Analogue Scale before and after applying the device (active or sham). | 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. | Each participant will rank the severity of her dysmenorrhea symptoms before and after the device use on the VAS scale from 0 to 100, where 0 determines- No pain and 100 determines Very painful. Then, the difference between the two measurements will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usage of pain relievers during the menstrual period | 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. | Usage of pain relievers during the menstrual period as recorded in the subjects' diaries. This will be measured by the number of pain relief pills taken during the entire menstrual period |
| Quality of life | 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. | Quality of life will be assessed using the Q-LES Questionnaire. The summary score will be determined as per the questionnaire manual |
| The convenience of device operation | 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. | The convenience of device operation and usage will be determined using a series of specific questions posed to the subjects at visit 3. |
Other
| Measure | Time frame | Description |
|---|---|---|
| SAFETY AND TOLERABILITY ENDPOINTS | 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. | The safety and tolerability endpoints of this study are Adverse events (AEs) and serious adverse events (SAEs) occurring at any time during the study Duration of device use |
Countries
Israel
Outcome results
None listed