Livia is a Class 2a medical instrument that has been shown to be effective in relieving menstrual pain in 3 separate clinical studies.

Here is a summary of these clinical studies on Livia and their results:

 

1) Study on a prototype.

A first study was carried out on an early prototype of the Livia instrument:

  • By Professor Bari Kaplan at the gynecological ward of Beilinson Hospital above
  • 61 women participated in this study. All said they had suffered from painful menstrual cycles.

They were closely monitored during 4 consecutive menstrual cycles:

  • During the first 2 menstrual cycles, no instrument was used. All women assessed the level of pain felt (1 to 10) and its location.
  • During the next 2 cycles, the Livia prototype was used. All women reassessed the level of pain felt (1 to 10) and its location
  • After the 4 cycles, the data were analyzed and the following positive results were observed in a statistically robust manner:

Use of the instrument relieves menstrual pain for 90% of women tested

  • 31% said they were relieved completely
  • 59% said they were moderately relieved
  • 10% said they had little or no relief

32% of women reported that the instrument relieves pain significantly faster than common medications.

 

 

2) Study of an improved prototype

Following the results of the first clinical study, many improvements have been developed to further improve the results.

A second clinical study was conducted on an improved prototype of the Livia instrument:

  • By Professor Bari Kaplan in the gynecological ward ofBeilisonHospital.
  • 102 women participated in this study. All declared having painful menstrual cycles.

They were closely monitored during 4 menstrual cycles:

  • During the first 2 cycles, no instrument was used. All women assessed the level of pain experienced (1 to 10) and the pain location.
  • In the next 2 cycles, the Livia prototype was used. All women reassessed the level of pain felt (1 to 10) and its location.
  • After the 4 cycles, the data were analyzed and the following positive results were observed in a statistically robust manner:

Use of the instrument relieves menstrual pain for 86% of the women tested.

  • 57% said they were relieved completely of any pain (compared to 31% with the first prototype as in 1)
  • 30% said they were moderately relieved of pain.
  • 13% reported little or no relief.–> Therefore the improvements in the instrument have significantly increased the proportion of fully relieved women.

72.5% of women reported that the instrument relieves significantly faster than common drugs (compared to 32% with the first prototype as in 1) –> the improvements in the instrument have significantly increased the speed of action of the instrument.

 

3) Double-blind, multi-site, randomized and controlled study on the Livia version made available on the market.

A third study was conducted to demonstrate the effectiveness and safety in the use of the Livia instrument put on sale in the markets.

  • This study was developed, controlled and carried out by the specialized company TechnoStat ii
  • on 4 geographically different study sites
  • with 4 different study managers
  • 65 women randomly divided into 2 groups:

 

Group A used Livia during their first menstrual cycle and a dummy instrument during their second cycle.

Group B used a dummy instrument during their first cycle and Livia during their second cycle

Each of the women visited the study centers three times:

  • A first visit to establish their pain levels during their period (1 to 10), and to evaluate their perceived quality of life levels
  • A second visit to:

 

 1. Establish their pain levels during their menses (1 to 10) while using either Livia or the fake instrument

2. Evaluate their perceived quality of life levels

3. Inquire the practical questions about the use of the Livia / dummy instrument

4.After the 3 menstrual cycles, the data were analyzed, and the following positive results were observed in a statistically robust manner:

 

The results:

  • The use of Livia during menstruation significantly reduces menstrual pain
  • The use of Livia reduced by an average of 28.1 points the perceived level of pain (Visual Analogue Scale (VAS) score)
  • A statistically significant difference between the use of Livia and the use of the dummy apparatus was observed (P < 0.0001)
  • Women observed an improvement in their quality of life levels when using Livia
  • Women appreciated Livia’s ease of use and the sense of security it generates

 

 

i    Robin Hospital at the Beilinson Medical Center – Hasharon, Israel

ii   TechnoStat, Data Management and Biostatistics Company, Israel

 

 

 

SCIENTIFICALLY APPROVED