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OpenTrials
Active, Not Recruiting

NCT Number: NCT06598514

Chlorhexidine Lavage for 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

55 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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)

Treatment and study plan

Chlorhexidine

Drug

Participants will use a 2% chlorhexidine perineal lavage following defecation

Sterile water

Drug

Participants will use a sterile water perineal lavage following defecation

Primary outcomes

  1. 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

Secondary outcomes

  1. Vulvovaginal Symptom Questionnaire (VSQ)

    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.

  2. Urinary Distress Inventory (UDI-6)

    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.

Other outcomes

  1. Participant Satisfaction with Virtual Recruitment

    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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Effect of Chlorhexidine Perineal Lavage Following Defecation in Post-Menopausal Women With Recurrent Urinary Tract Infection

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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