Nutraceutical Efficacy for rUTI
Summary
This is a study designed to evaluate the efficacy of a nutraceutical as a non-antibiotic treatment to prevent recurrent urinary tract infections in women that have completed menopause and are on vaginal estrogen therapy. An additional group of women with recurrent urinary tract infections that have completed menopause but are not using vaginal estrogen therapy will be followed while taking the nutraceutical. The study length is ninety days from the date that the study participant will be instructed is day 1.
Timeline
- Start
- 2018-03-22
- Primary completion
- 2020-04-25
- Completion
- 2020-04-25
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
Stopped: “Performed a futility analysis and determined that study objectives could not be met.”
paper Futility analysis suggested the study lacked power to detect the planned (25%) or observed (9%) difference as statistically significant; the study was halted before conclusion. PMID 36808931 ↗
Publications
- Lenger SM, Chu CM, Ghetti C, Durkin MJ, Jennings Z, Wan F, Sutcliffe S, Lowder JL. d-Mannose for Recurrent Urinary Tract Infection Prevention in Postmenopausal Women Using Vaginal Estrogen: A Randomized Controlled Trial. Urogynecology (Phila). 2023 Mar 1;29(3):367-377. doi: 10.1097/SPV.0000000000001270. Epub 2022 Oct 15.
- Lenger SM, Chu CM, Ghetti C, Durkin MJ, Jennings Z, Sutcliffe S, Lowder JL. Feasibility and Research Insights From a Randomized Controlled Trial for Recurrent Urinary Tract Infection Prevention in Postmenopausal Women Using Vaginal Estrogen Therapy. Female Pelvic Med Reconstr Surg. 2022 Jun 1;28(6):e163-e170. doi: 10.1097/SPV.0000000000001171.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | D-mannose | Unknown | 1000 mg | — |
| Subject | D-mannose | Unknown | 2 g | — |