None listed
Conditions
Brief summary
“Recurrent cystitis is common after menopause. This study will compare two preventive approaches in postmenopausal women aged 50–70 years with recurrent cystitis: cranberry-based preparations and vaginal estriol. Eighty participants will be randomly assigned to one of the two groups and followed for six months. Participants will be contacted monthly by phone to monitor symptoms of recurrence. Urine tests will be performed at 3 and 6 months, and urine culture at 6 months. The main aim is to determine which approach reduces the number of recurrences over six months and assess tolerability.”
Interventions
Group with Vaginal estrogen treatment
Estriol 0.5 mg vaginal suppositories (intravaginal administration): one suppository daily for 2 weeks, followed by one suppository twice weekly for the remainder of the 6-month follow-up period, unless stopped for intolerance/contraindication.
Adherence monitoring: adherence will be assessed at each monthly telephone follow-up using a structured questionnaire. Participants will also be asked to confirm continued use at each scheduled contact.
In addition
Group with Vaginal estrogen treatment Estriol 0.5 mg vaginal suppositories (intravaginal administration): one suppository daily for 2 weeks, followed by one suppository twice weekly for the remainder of the 6-month follow-up period, unless stopped for intolerance/contraindication. Adherence monitoring: adherence will be assessed at each monthly telephone follow-up using a structured questionnaire. Participants will also be asked to confirm continued use at each scheduled contact. In addition to monthly telephone follow-up, participants will undergo protocol-scheduled laboratory assessments, including urinalysis at 3 months and, at 6 months from initiation of therapy, both urinalysis and urine culture (bacteriological culture).
Sponsors
BAU International University Batumi
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Female, postmenopausal, 50–70 years. Recurrent cystitis: three or more episodes in the last 12 months OR two or more episodes in the last 6 months. Able and willing to provide informed consent and participate in 6-month follow-up.
Exclusion criteria
Diabetes mellitus Chronic kidney disease Malignancy Current or previous chemo-/radiotherapy Rheumatologic disease requiring hormonal and/or immunosuppressive therapy.
Outcome results
None listed