+1 (502) 904-2126   One Westbrook Corporate Center, Suite 300, Westchester, IL 60154, USA   Site Map
ISSN: 2574 -1241

Impact Factor : 0.548

  Submit Manuscript

Research ArticleOpen Access

Dysmenorrhea: A Randomized Controlled Clinical Trial Evaluating a Novel Treatment Approach

Volume 2 - Issue 1

Hilla Shaviv1, Doron JD Rosen2 and Yossef Ezra*3

  • Author Information Open or Close
    • 1GalMedics Biotech Ltd, Israel
    • 2Department of Obstetrics and Gynecology, Meir Medical Center, Israel
    • 3Department of Obstetrics and Gynecology, Hadassah Hebrew University Medical Center, Israel.

    *Corresponding author: Yossef Ezra, Department of Obstetrics and Gyencology, Hadassah Hebrew University Medical Center, Ein-Kerem, Jerusalem, Israel, POBox 12000, Zip 9112001

Received: January 19, 2018;   Published: January 30, 2018

DOI: 10.26717/BJSTR.2018.02.000706

Full Text PDF

To view the Full Article   Peer-reviewed Article PDF


Objective: To evaluate a new treatment for dysmenorrhea by inducing menstrual fluid streaming mechanically.

Setting: A 4-month randomized double-blind, placebo-controlled, crossover study.

Participants: Study participants were women experiencing dysmenorrhea monthly (for the 6 preceding months) at a level >5 on the visual analog scale (0-10), who were otherwise healthy. The study participants also collected their menstrual fluid for 2 baseline months, while recording their pain levels (primary outcome) systematically. A correlation between menstrual fluid characteristics and menstrual pain was studied, too.

Intervention: A newly invented device was used to attenuate dysmenorrheic pain level.

Results: From September 2011 to December 2013, 28 study participants were enrolled; 3 withdrew and 3 were excluded for protocol non-adherence. Twenty-two study participants (132 menstrual cycles) who used the device reported an average reduction of 55±7.6% in pain levels vs. 22±12% reported with placebo (p = 0.008). Analysis of menstrual fluid collected from 19 study participants (38 menstrual cycles) showed high correlation between pain levels and menstrual fluid viscosity/tissue fragments, indicating that dysmenorrhea is closely related to the rheological characteristics of the menstrual fluid.

Conclusions: The new device is highly effective in relieving menstrual pain. Rheological characteristics of the menses are correlated with severity of dysmenorrhea.

Key words: Dysmenorrhea; Menses; Randomized trial; Rheology; Vaginal device; Acti Lady

Abbreviations: PD: Primary Dysmenorrhea; NSAIDs: Nonsteroidal Anti-Inflammatory Drugs; AEs: Adverse Events; OC: Oral Contraceptives; IRB: Institutional Review Board

Abstract| Introduction| Materials and Methods| Result| Discussion| Disclosure Statement| Acknowledgement| References|