Oregon Health & Science University
Portland, Oregon, 97239, United States
NCT Number: NCT06598514
A two-arm randomized control trial evaluating rates of urinary tract infection in post-menopausal women on vaginal estrogen with recurrent urinary tract infections.
This study is active but is not currently recruiting participants.
55 year–89 year
Female
Interventional
Phase 4
Portland, Oregon, 97239, United States
There is a critical need for low-cost, non-antibiotic interventions that are feasible for patients to utilize for risk reduction and prevention of recurrent urinary tract infections (UTIs). The current most effective non-antibiotic prophylaxis for recurrent UTI is vaginal estrogen; however, approximately 50% of women will continue to experience UTIs. The investigators propose a randomized control trial of postmenopausal women on vaginal estrogen with the diagnosis of recurrent UTIs to evaluate a novel post-defecation hygienic strategy utilizing a 2% chlorhexidine perineal lavage. Participants will be randomized to either a 2% chlorhexidine perineal lavage or a water lavage. Study participants will be followed for up to 6-months, and UTIs will be tracked with culture proven samples throughout study participation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will use a 2% chlorhexidine perineal lavage following defecation
Participants will use a sterile water perineal lavage following defecation
Time frame: 90 days following treatment initiation
The proportion of participants in each arm who experience a urinary tract infection (UTI) within 90 days will be compared
Time frame: VSQ administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization
Vulvovaginal symptoms will be evaluated using the VSQ from baseline to post-intervention and compared between the groups with and without chlorhexidine in their perineal lavage. The VSQ is scored on a scale of 0-16 for those who are not sexually active or 0-20 for those who are sexually active, with a higher score indicating worse outcomes.
Time frame: UDI-6 administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization
Urinary symptoms will be evaluated using the UDI-6 from baseline to post-intervention and compared between the groups with and without chlorhexidine in their perineal lavage. It is scored on a scale from 0 to 100 with higher scores indicating worse outcomes.
Time frame: Upon completion of the intervention period, 90 days after randomization
Satisfaction with virtual recruitment and enrollment will be evaluated using the Patient Global Impression scales to allow for participant reported outcomes regarding perceived change following intervention. It is scored on a scale from 1 to 7 with a higher score indicating a worse outcome.
Oregon Health and Science University
Other
Effect of Chlorhexidine Perineal Lavage Following Defecation in Post-Menopausal Women With Recurrent Urinary Tract Infection
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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