Urinary Tract InfectionsPhase 4NCT06598514
Chlorhexidine Lavage for Recurrent Urinary Tract Infection
A Phase 4 study testing Chlorhexidine and Sterile Water in people with Urinary Tract Infections and Recurrent Urinary Tract Infection, run by Oregon Health and Science University at 1 site in United States.
Trial summary
A two-arm randomized control trial evaluating rates of urinary tract infection in post-menopausal women on vaginal estrogen with recurrent urinary tract infections. Read more about this study
- Who is it for?
- Ages 55 to 89 years, women only
- Conditions the study is for
- Urinary Tract Infections, Recurrent Urinary Tract Infection
- What is being tested?
- Chlorhexidine and Sterile Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2024to Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-menopausal female between age 55 and 89
- No post-menopausal bleeding
- Diagnosis of recurrent urinary tract infection (UTI) in the electronic health record or as two culture proven UTIs in 6 months or three culture proven UTIs in 12 months
- At least one UTI in the 6 months prior to entering the study
- Asymptomatic for UTI symptoms at the time of enrollment.
- On vaginal estrogen therapy for at least 6 weeks prior to enrollment
- Ready access to email and internet
Who cannot join
- Recent prophylactic antibiotic use (washout period of 4 weeks)
- Neurogenic bladder
- Diagnosis of urinary retention
- Uncorrected Stage III-IV prolapse
- Indwelling catheter or need for intermittent self-catheterization
- History of complicated UTIs
Show all 13Show fewer
- History of interstitial cystitis or bladder pain syndrome
- History of fecal incontinence/accidental bowel leakage
- Greater than 14 bowel movements per week
- Non-English speaking
- Allergy to chlorhexidine gluconate
- Inability to utilize vaginal estrogen therapy
- Recent urogynecological or urologic surgery (<12 weeks)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Effect of Chlorhexidine Perineal Lavage Following Defecation in Post-Menopausal Women With Recurrent Urinary Tract Infection
A two-arm randomized control trial evaluating rates of urinary tract infection in post-menopausal women on vaginal estrogen with recurrent urinary tract infections.
Read the detailed description
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.
- Being tested
- Chlorhexidine, Sterile Water
- Keywords
- Menopause
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineDrug
Participants will use a 2% chlorhexidine perineal lavage following defecation
Sterile WaterDrug
Participants will use a sterile water perineal lavage following defecation
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine Lavage | Experimental | 2% chlorhexidine perineal lavage following defecation Receives: Drug: Chlorhexidine |
| Sterile Water Lavage | Active comparator | Sterile water perineal lavage following defecation Receives: Drug: Sterile Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days following treatment initiation
Secondary outcomes (2)
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.
Measured: VSQ administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization
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.
Measured: UDI-6 administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start23 Dec 2024
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Cichowski, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598514
- Sponsor's protocol ID
- STUDY00027352
- Status last verified
- Jan 2026
- First submitted
- 14 Sep 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chlorhexidine Perineal Lavage Following Defecation in Post-Menopausal Women With Recurrent Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT06598514
- Acronym / sponsor ID
- STUDY00027352
- Keywords
- Menopause
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A two-arm randomized control trial evaluating rates of urinary tract infection in post-menopausal women on vaginal estrogen with recurrent urinary tract infections.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine Lavage | Experimental | Drug: Chlorhexidine2% chlorhexidine perineal lavage following defecation |
| Sterile Water Lavage | Active comparator | Drug: Sterile WaterSterile water perineal lavage following defecation |
Who may qualify
- Ages
- 55 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Post-menopausal female between age 55 and 89
- No post-menopausal bleeding
- Diagnosis of recurrent urinary tract infection (UTI) in the electronic health record or as two culture proven UTIs in 6 months or three culture proven UTIs in 12 months
- At least one UTI in the 6 months prior to entering the study
- Asymptomatic for UTI symptoms at the time of enrollment.
Key exclusion criteria (13 listed)
- Recent prophylactic antibiotic use (washout period of 4 weeks)
- Neurogenic bladder
- Diagnosis of urinary retention
- Uncorrected Stage III-IV prolapse
- Indwelling catheter or need for intermittent self-catheterization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChlorhexidineParticipants will use a 2% chlorhexidine perineal lavage following defecation | Drug | Chlorhexidine Lavage |
| Sterile WaterParticipants will use a sterile water perineal lavage following defecation | Drug | Sterile Water Lavage |
Primary outcome
Rate of Urinary Tract Infection (UTI)
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
2 secondary outcomes
Vulvovaginal Symptom Questionnaire (VSQ)
Time frame: VSQ administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization
Urinary Distress Inventory (UDI-6)
Time frame: UDI-6 administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorhexidine and Sterile Water in people with Urinary Tract Infections and Recurrent Urinary Tract Infection, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Urinary Tract Infection (UTI) (time frame: 90 days following treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.