Dr Janet Wilson
Consultant in Genito-Urinary Medicine
Leeds Teaching Hospitals NHS Trust
What is the study about?
Bacterial vaginosis (BV) causes a vaginal discharge that has an unpleasant smell. It is the most common cause of discharge and up to a third of women will get it at some time in their lives. We do not know why BV occurs but there is a change in the balance of the vaginal bacteria with a reduction in the ‘good’ bacteria that protect against infections and an increase in many other bacteria. Current treatments often do not not cure BV completely, but treating BV is important as the symptoms are unpleasant. Also, it can cause miscarriage, premature birth and it increases the risk of catching HIV and other sexually transmitted infections.
Oral or vaginal antibiotics are recommended for treating BV. These can cause side effects such as dizziness, nausea and vaginal soreness. Over 1 in 5 women get BV back within one month of treatment and have to take repeated courses of antibiotics. Concern about bacteria becoming resistant to antibiotics and damage to the body’s good bacteria means that non-antibiotic therapies are being considered for BV.
There is a new treatment available for BV called dequalinium which works as a vaginal antiseptic. Its potential advantages are that it will not damage the good bacteria throughout the body or cause antibiotic resistance.
Who can take part in the study?
Women aged 16 years and over with Bacterial Vainosis (BV)
What is being tested in the study?
The intervention arm will receive dequalinium chloride 10 mg vaginal tablet for 6 nights. This is the formulation and course that is licensed for use in the UK.
What is this being compared to?
The control arm will receive usual care antibiotics. Clinician-chosen usual care antibiotic treatment selected from UK guideline-recommended or alternative oral or topical antibiotic BV treatments.
What are we trying to find out?
The aim of this study is to see if dequalinium is as good at treating BV as current BV antibiotics.
How many patients do we need?
National Institute for Health and Care Research - Health Technology Assessment (NIHR - HTA)