Back to resultsThe Effectiveness and Safety of LIVIA® Transcutaneous Electrical Nerve Stimulation (TENS) in Women Suffering From Primary Dysmenorrhea.
Primary Purpose
Dysmenorrhea
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Livia
Sponsored by
About this trial
This is an interventional treatment trial for Dysmenorrhea focused on measuring Livia TENS, safety and efficacy, menstruating women
Eligibility Criteria
Inclusion Criteria:
- Women between the age 18 to 45 years
- Women reporting painful menstruation during the last 3 menstrual cycles.
- Pain VAS score of at least 60 based on previous menstrual cycle
- Subject is willing and able to comply with the study protocol and provide written informed consent to participate in the study.
- 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:
- Participation in any other investigational study within 30 days prior and/or at the date of subject consent.
- 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.
- Pregnant woman
- A woman who is diagnosed with secondary dysmenorrhea associated with uterine myomas, endometriosis, adenomyosis, etc.
- A woman who has cardiac condition with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices.
Sites / Locations
- Hadassah
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Shame device
Livia® Transcutaneous Electrical Nerve Stimulation (TENS)
Arm Description
Outcomes
Primary Outcome Measures
The difference between the reported Visual Analogue Scale before and after applying the device (active or sham).
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 Outcome Measures
Usage of pain relievers during 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
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
The convenience of device operation and usage will be determined using a series of specific questions posed to the subjects at visit 3.
Full Information
NCT ID
NCT03064945
First Posted
February 22, 2017
Last Updated
April 29, 2018
Sponsor
iPulse Medical Ltd. (Livia)
1. Study Identification
Unique Protocol Identification Number
NCT03064945
Brief Title
The Effectiveness and Safety of LIVIA® Transcutaneous Electrical Nerve Stimulation (TENS) in Women Suffering From Primary Dysmenorrhea.
Official Title
A Randomized, Controlled, Multi-Center, CROSSOVER, Prospective, Double-blind Clinical Study to Assess the Effectiveness and Safety of Livia® Transcutaneous Electrical Nerve Stimulation (TENS) in Women Suffering From Primary Dysmenorrhea
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
April 25, 2018 (Actual)
Study Completion Date
April 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
iPulse Medical Ltd. (Livia)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
Keywords
Livia TENS, safety and efficacy, menstruating women
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Shame device
Arm Type
Sham Comparator
Arm Title
Livia® Transcutaneous Electrical Nerve Stimulation (TENS)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Livia
Intervention Description
Livia® Transcutaneous Electrical Nerve Stimulation (TENS) is a novel pain management device for women suffering from dysmenorrhea
Primary Outcome Measure Information:
Title
The difference between the reported Visual Analogue Scale before and after applying the device (active or sham).
Description
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.
Time Frame
3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.
Secondary Outcome Measure Information:
Title
Usage of pain relievers during the menstrual period
Description
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
Time Frame
3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.
Title
Quality of life
Description
Quality of life will be assessed using the Q-LES Questionnaire. The summary score will be determined as per the questionnaire manual
Time Frame
3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.
Title
The convenience of device operation
Description
The convenience of device operation and usage will be determined using a series of specific questions posed to the subjects at visit 3.
Time Frame
3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.
Other Pre-specified Outcome Measures:
Title
SAFETY AND TOLERABILITY ENDPOINTS
Description
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
Time Frame
3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study on women that suffering from painful menstruation
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women between the age 18 to 45 years
Women reporting painful menstruation during the last 3 menstrual cycles.
Pain VAS score of at least 60 based on previous menstrual cycle
Subject is willing and able to comply with the study protocol and provide written informed consent to participate in the study.
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:
Participation in any other investigational study within 30 days prior and/or at the date of subject consent.
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.
Pregnant woman
A woman who is diagnosed with secondary dysmenorrhea associated with uterine myomas, endometriosis, adenomyosis, etc.
A woman who has cardiac condition with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices.
Facility Information:
Facility Name
Hadassah
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Effectiveness and Safety of LIVIA® Transcutaneous Electrical Nerve Stimulation (TENS) in Women Suffering From Primary Dysmenorrhea.
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