Hyaluronate for the Treatment and Prevention of Recurrent Urinary Tract Infection in Women Suffering Atrophic Vaginitis (HATPIN)
Atrophic Vaginitis, Urinary Tract Infections
About this trial
This is an interventional treatment trial for Atrophic Vaginitis
Eligibility Criteria
Inclusion Criteria:
• Postmenopausal women not receiving hormonal supplementation.
- Women with atrophic vaginitis and rUTI who, in consultation with a clinician, have decided that either hyaluronate treatment (intravesical or vaginal) is an appropriate option.
- Women who have suffered at least three episodes of symptomatic UTI within the preceding 12 months or two episodes in the last 6 months.
- Able to attend a urology clinic for catheterisation on a regular basis (initially weekly) to initiate intravesical bladder instillation treatment.
- Able to apply vaginal hyaluronate gel at home every 3 days.
- Able to give informed consent for participation in study.
- Able and willing to adhere to a 9-month study period.
Exclusion Criteria:
• Postmenopausal women receiving hormonal supplementation (e.g. HRT or oestrogen creams).
- Women unable to use hyaluronate e.g. due to previous sensitivity issues.
- Women with urinary tract abnormalities that are considered to be contributory to the occurrence of rUTI.
- Presence of symptomatic UTI - this will be treated and symptoms resolved prior to randomisation.
- Women currently using hyaluronate for either treatment of atrophic vaginitis or prevention of recurrent UTI or women who have used either study treatment in the preceding 12 months.
- Women receiving prophylactic antibiotics.
- Catheter usage.
Sites / Locations
- Freeman HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Hyalofemme
Ialuril
Hyalofemme is a cream/gel containing hyaluronic acid, designed to be applied vaginally. This is primarily used in treatment of atrophic vaginitis and is applied by the patient once every three days. We intend treatment to continue for 6 months.
Ialuril is a bladder instillation designed to be delivered to the bladder via catheter. This is primarily used in patients suffering from recurrent UTI and acts to help rebuild the lining of the bladder, reducing irritation. Ialuril is applied weekly for 6 weeks, followed by every 2 weeks for 6 weeks, then once monthly for maintenance. Treatment will be continued for 6 months.