Bacterial vaginosis Urological and Genital Diseases Bacterial vaginosis
Conditions
Interventions
Participants will be assigned to treatment groups using a remote internet-based randomization system to one of the following the intervention or control arm.
The intervention arm will receive dequali
Sponsors
Leeds Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
Female
Age
16 Years to 110 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 06/10/2023: 1. People with a vagina (assigned female at birth) aged 16 years and over 2. Diagnosis of BV confirmed by microscopy with symptoms of vaginal odour plus or minus vaginal discharge requiring treatment with usual care (BV guideline recommended) antibiotics 3. Willing to use either intravaginal dequalinium chloride tablets (pessaries) or the clinician selected usual care antibiotic BV treatment 4. Willing to avoid vaginal sex whilst taking/using trial treatment 5. Willing to avoid vaginal douching whilst taking/using trial treatment 6. Willing to complete follow up _____ Previous inclusion criteria: 1. Cisgender women aged 16 years and over 2. Diagnosis of BV confirmed by on-site microscopy (Ison-Hay Grade 3) with symptoms of vaginal odour plus or minus vaginal discharge requiring treatment with usual care (BV guideline recommended) antibiotics 3. Willing to use either intravaginal dequalinium chloride tablets (pessaries) or the clinician selected usual care antibiotic BV treatment 4. Willing to avoid vaginal sex whilst taking/using trial treatment 5. Willing to avoid vaginal douching whilst taking/using trial treatment 6. Willing to complete follow up questionnaires in English 7. Written informed consent to participation given
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 06/10/2023: 1. Contra-indications or allergy to dequalinium chloride or clinician selected usual care antibiotic BV treatment 2. Use of antibiotics concurrently, within the 14 days prior to randomisation or planned use over the 14 days from randomisation 3. Use of intravaginal therapies (including vaginal douching) concurrently, within the 14 days prior to randomisation or planned use over the 14 days from randomisation 4. Pregnant females who are seeking a termination 5. Unwilling to provide GP information (only to be used for pregnant females or females who become pregnant in the first 4 weeks of the trial) 6. Current use of gender affirming hormones (androgens and anti-oestrogens) 7. Previous participation in this trial 8. Resident outside the UK (for shipment of trial medication and sample kits only) ______ Previous exclusion criteria: 1. Contra-indications or allergy to dequalinium chloride or clinician selected usual care antibiotic bacterial vaginosis (BV) treatment 2. Concurrent use of oral antibiotics, within the past 14 days or planned use over the next 14 days 3. Concurrent use of intravaginal therapies (including vaginal douching), within the past 14 days or planned use over the next 14 days 4. Diagnosis of any infection at the baseline visit that requires immediate antibiotic treatment 5. Pregnant women who are seeking a termination 6. Pregnant women or women who become pregnant in the first 4 weeks of the trial who are unwilling to provide GP information 7. Previous participation in this trial Added 11/05/2021: 8. Resident outside the UK (for shipment of trial medication and sample kits only)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant-reported resolution of bacterial vaginosis (BV) symptoms without the need for additional treatment assessed by online questionnaire at 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Participant-reported resolution of bacterial vaginosis (BV) symptoms (with or without the need for additional treatment) assessed by online questionnaire at 4 weeks 2. Time to participant-reported resolution of BV symptoms without the need for additional treatment assessed by online questionnaire at 4 weeks 3. Microscopic resolution of BV (without the need for additional treatment) on microscopy at 4 weeks as assessed by central laboratory analysis of participant-taken vaginal smears (in a subgroup of participants) 4. Participant reported proportion of prescribed trial BV treatment taken assessed by online questionnaire at 4 weeks 5. Participant-reports of vaginal irritation (itching, pain and/or burning), vaginal discharge, unpleasant vaginal smell, nausea, vomiting, diarrhoea, abdominal pain, unpleasant taste and candida infection assessed by online questionnaire at 4 weeks and 12 weeks 6. Participant-reported acceptability of /satisfaction with treatment assessed by online questionnaire at 4 weeks 7. Participant-reported recurrence of BV symptoms assessed by online questionnaire at 12 weeks 8. Time to participant reported recurrence of BV symptoms assessed by online questionnaire at 12 weeks 9. Cost of BV treatment, including additional medication and healthcare usage relating to BV assessed by online questionnaire at 4 weeks and 12 weeks | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactMickey Lewis
Outcome results
None listed