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A two-arm randomized control trial evaluating rates of urinary tract infection in post-menopausal women on vaginal estrogen with recurrent urinary tract infections.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine Lavage | Experimental | 2% chlorhexidine perineal lavage following defecation |
|
| Sterile Water Lavage | Active Comparator | Sterile water perineal lavage following defecation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine | Drug | Participants will use a 2% chlorhexidine perineal lavage following defecation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Urinary Tract Infection (UTI) | The proportion of participants in each arm who experience a urinary tract infection (UTI) within 90 days will be compared | 90 days following treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Vulvovaginal Symptom Questionnaire (VSQ) | 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. | VSQ administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Satisfaction with Virtual Recruitment | 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. | Upon completion of the intervention period, 90 days after randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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Individuals meeting inclusion criteria will be randomized to the treatment (2% chlorhexidine perineal lavage following defecation) or control (sterile water perineal lavage following defecation) and rates of urinary tract infection will be compared. Balanced randomization will be performed via computer-generated assignments in REDCap with random permuted blocks varying in size between 8 and 10.
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Participants will be blinded to their assigned treatment. All participants will receive a box containing their randomized intervention and identical use instructions. Opaque bottles will contain either a sterile water solution or 2% chlorhexidine. Spray bottles will be identical in external appearance.
| Sterile Water | Drug | Participants will use a sterile water perineal lavage following defecation |
|
| Urinary Distress Inventory (UDI-6) | 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. | UDI-6 administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |