Dysmenorrhea
Conditions
Brief summary
ActiLady refers is employing targeted pressure waves, with the goal of reducing the pain associated with menstruation (clinically known as dysmenorrhea).
Interventions
DEVICEMiniature Actilady device active
Devices: Targeted pressure waves are created by two kind of methods ActiLady). 1. The effect of the waves used will be examined by the use of a silicon tube or polyvinyl chloride (PVC) tube which is inserted into the vaginal cavity. The other end of the tube will be connected to an off the shelf pressure waves generator and controller. 2. Self manufactured device inserted into the vaginal cavity and creating subsound pressure waves.
DEVICEMiniature Actilady device not active
Devices: Targeted pressure waves are created by two kind of methods ActiLady). The effect of the waves used will be examined by the use of a silicon tube or polyvinyl chloride (PVC) tube which is inserted into the vaginal cavity. The other end of the tube will be connected to an off the shelf pressure waves generator and controller. Self manufactured device inserted into the vaginal cavity and creating subsound pressure waves.
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
1. Women aged 18-35 years 2. Regular menstrual cycles (26-35 days); average duration of menstruation ≥5 days for the 4 months preceding the beginning of the trial. 3. Dysmenorrhea pain score \>50mm on a 100mm visual analog scale (VAS) for the maximum abdominal pain 4. Analgesic use during every menstrual cycle 5. Non-pregnant, with no intentions to get pregnant during the clinical trial 6. Agrees not to use oral contraceptives or an intrauterine device (IUD) during the trial period 7. Agrees not to use analgesics, except during permitted period (16:00-04:00 the next day, daily) 8. Consents to the use of pads or other vaginal devices throughout the trial period 9. Subject is able to comply with all the requirements of the study and agrees to participate in all the activities of the study 10. Signed written informed consent form (ICF) to participate in the study
Exclusion criteria
1. Pregnant or lactating women 2. Used hormonal and/or oral contraceptives in the preceding 4 months 3. Use of an IUD in the preceding 4 months 4. Previous diagnosis of secondary dysmenorrhea 5. Urinary incontinence 6. Duration of menstruation is \<5 days 7. Subjects with a known sensitivity to mechanical vibrations and/or silicone 8. Participation in current or recent clinical trial within 30 days prior to baseline visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of a novel method and device called ActiLady. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| * Evaluate the pain-reducing effect of ActiLady on dysmenorrhea. * Study the relationship between menses flux and dysmenorrhea. [Time Frame: 6 months] [Designated as safety issue: No ] * Optimize treatment procedure and wave form. | 6 months |
Countries
Israel
Outcome results
None listed