Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201909636228452 Date of Registration: 12/09/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Controlled clinical trial evaluating safety and efficacy of Vascular Electrical Stimulation Therapy on severe dysmenorrhea.
Official scientific title Controlled randomized Phase II clinical trial evaluating safety and efficacy of Vascular Electrical Stimulation Therapy on severe dysmenorrhea
Brief summary describing the background and objectives of the trial Primary dysmenorrhea, or painful menstruation in the absence of pelvic pathology, is a common, and often debilitating, gynecological condition that affects between 45 and 95% of menstruating women. Despite the high prevalence, dysmenorrhea is often poorly treated, and even disregarded, by health professionals, pain researchers, and the women themselves, who may accept it as a normal part of the menstrual cycle. The objective of the current trial is to evaluate the efficacy and the safety of Vascular Electrical Stimulation Therapy on womens suffering from dysmenorrhea. Pain duration and NSAIDs consumption will be compared between treated patients and control ones.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) VESTCI201902
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Dysmenorrhea
Purpose of the trial Treatment: Devices
Anticipated trial start date 30/09/2019
Actual trial start date
Anticipated date of last follow up 30/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group VEST Treatment 25V 30 minutes VEST stimulation on the two legs. 50
Control Group Placebo group 0V 30 Minutes Simulation of treatment 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Severe menstrual pain (VAS over 4) Dysmenorrhea every month for at least one year Patients treated with analgesic drug prior to recrutment Patient under 18 years old Chronic renal disease Cardiac insuffisiency Suspicion of general or vaginal infection Gastric ulcere Chronical pelvic pain Pacemaker NSAIDs allergy or intolerance Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/08/2019 Comite National d ethique des sciences de la vie et de la sante
Ethics Committee Address
Street address City Postal code Country
Institut pasteur CHU de Cocody Abidjan 00000 Cote Divoire
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Duration 5 days
Secondary Outcome NSAIDs consumption 5 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dispensaire dAkouedo Attie Rte dAbatta Bingerville Cote Divoire
Centre medical Le Chapelet Rte d Abatta Abidjan Riviera 4 Cote Divoire
FUNDING SOURCES
Name of source Street address City Postal code Country
Diavein SAS 227 Rte de la chapelle St felix 74540 France
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Diavein SAS 227 Rte de la Chapelle St Felix 74540 France Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Dr Mandeng Edgar Rte dAbatta Abidjan Cote Divoire
NGatta Prisca Campus de lUniversite FHB Abidjan Cote Divoire
Dr Agnissan Kimou Centre medical du Chapelet Abidjan Cote Divoire
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Boston Mian bostondehimian@yahoo.fr +22507963911 CHU Cocody
City Postal code Country Position/Affiliation
Abidjan Cote Divoire Professor
Role Name Email Phone Street address
Scientific Enquiries Edgar Mandeng macadamcity_2007@yahoo.fr +22544162060 Rte dAbatta
City Postal code Country Position/Affiliation
Bingerville Cote Divoire Coinvestigator
Role Name Email Phone Street address
Public Enquiries Etienne L Hermite elhermite@diavein.com +33615773953 227 Rte de la Chapelle
City Postal code Country Position/Affiliation
St Felix 74540 France Coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Publication of the results Clinical Study Report Within 6 months after completion of the study free access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not yet available No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information