- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05880602
Nettle and Cranberry Capsules for Prevention of Urinary Tract Infection
Clinical Trial of Nettle and Cranberry Capsules for Prevention of Urinary Tract Infection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Urinary tract infections (UTIs) are one of the most common bacterial infections affecting women. UTI occurs in 50-80% of women in the general population. About one in four women with one UTI episode will go on to develop frequent recurrences.
Recurrent urinary tract infection (rUTI) is defined as repeated UTI with a frequency of at least two episodes in the preceding six months or three episodes in the past year. rUTI has been regarded as a substantial global healthcare problem.
This investigation is a randomized, double-blind study. Subjects with confirmed diagnosis of rUTI are randomly assigned to control group or treatment group, and asked to orally intake 2 capsules of either placebo or nettle and cranberry complex capsules twice daily. Participants will be assessed for parameters, including international prostate symptoms score (IPSS) (male only), overactive bladder symptom score (OABSS), international consultation on incontinence questionnaire - overactive bladder (ICIQ-OAB), 3-day bladder diary (3dBD) and urine routine. The assessments are conducted at baseline, 4 weeks, and 8 weeks after the oral intake period. The parameters are used to compare and evaluate whether the nettle and cranberry complex capsule can prevention rUTI.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taichung, Taiwan, 40201
- Chung Shan Medical University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged between 30 and 75 years
- at least two episodes in 6 months, or at least three episodes of a UTI in 12 months.
Exclusion Criteria:
- pregnancy women
- diabetes
- History of anatomical urogenital anomalies, urogenital tract surgery
- History of acute or chronic renal failure, nephrolithiasis
- History of intestinal diseases causing malabsorption
- Anticoagulant medication in the last month
- immunocompromise
- Known allergy or intolerance to cranberry
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Control
Subjects will take two capsule of containing starch, twice a daily for 8 weeks.
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A specific capsule product, containing starch will be given to participants for oral intake for 8 weeks.
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Experimental: Treatment
Subjects will take two capsule of containing nettle and cranberry complex, twice a daily for 8 weeks.
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A specific capsule product, containing nettle and cranberry complex will be given to participants for oral intake for 8 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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UTI-free duration in 8 weeks
Time Frame: on baseline and 8 weeks
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Comparing the number of days from the beginning of the study to the first recurrence of UTI, and the number of days from each recurrence to the next recurrence between different treatment groups.
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on baseline and 8 weeks
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UTI recurrent incidence in 8 weeks
Time Frame: 8 weeks
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UTI episodes during 8 weeks treatment for each subject
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
International Prostate Symptom Score (IPSS) Change from Baseline
Time Frame: on baseline,4 weeks and 8 weeks
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The IPSS questionnaire is a tool commonly used to assess the severity of LUTS, and to monitor the progress of the symptoms during treatment.
Score range is 0-35, with higher scores indicating increasing symptom severity.
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on baseline,4 weeks and 8 weeks
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Overactive Bladder Symptom Score (OABSS) Change from Baseline
Time Frame: on baseline,4 weeks and 8 weeks
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OABSS is a valid self-assessment questionnaire, with four questions set according to OAB syndrome to determine the severity of OAB, which includes daytime and nighttime urination frequency, urgency, and urge incontinence.
Score range is 0-15, with higher scores indicating increasing symptom severity.
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on baseline,4 weeks and 8 weeks
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International Consultation on Incontinence Questionnaire Overactive Bladder Score (ICIQ-OAB) Change from Baseline
Time Frame: on baseline,4 weeks, and 8 weeks
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Assessment of quality of life related to the impact of overactive bladder symptoms on daily activities. Assessment of quality of life related to the impact of overactive bladder symptoms on daily activities Assessment of quality of life related to the impact of overactive bladder symptoms on daily activities. |
on baseline,4 weeks, and 8 weeks
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Bladder diary
Time Frame: on baseline,4 weeks, and 8 weeks
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Assessment of number of voids, number of leakages, and post void residual.
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on baseline,4 weeks, and 8 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Pei-Cheng Lin, PhD, Chung Shan Medical University
Publications and helpful links
General Publications
- Foxman B, Barlow R, D'Arcy H, Gillespie B, Sobel JD. Urinary tract infection: self-reported incidence and associated costs. Ann Epidemiol. 2000 Nov;10(8):509-15. doi: 10.1016/s1047-2797(00)00072-7.
- Fowler CJ, Griffiths D, de Groat WC. The neural control of micturition. Nat Rev Neurosci. 2008 Jun;9(6):453-66. doi: 10.1038/nrn2401.
- Stamm WE, Norrby SR. Urinary tract infections: disease panorama and challenges. J Infect Dis. 2001 Mar 1;183 Suppl 1:S1-4. doi: 10.1086/318850. No abstract available.
- Harding GK, Ronald AR. The management of urinary infections: what have we learned in the past decade? Int J Antimicrob Agents. 1994 Jun;4(2):83-8. doi: 10.1016/0924-8579(94)90038-8.
- Sivick KE, Mobley HL. Waging war against uropathogenic Escherichia coli: winning back the urinary tract. Infect Immun. 2010 Feb;78(2):568-85. doi: 10.1128/IAI.01000-09. Epub 2009 Nov 16.
- Sihra N, Goodman A, Zakri R, Sahai A, Malde S. Nonantibiotic prevention and management of recurrent urinary tract infection. Nat Rev Urol. 2018 Dec;15(12):750-776. doi: 10.1038/s41585-018-0106-x.
- Kwok M, McGeorge S, Mayer-Coverdale J, Graves B, Paterson DL, Harris PNA, Esler R, Dowling C, Britton S, Roberts MJ. Guideline of guidelines: management of recurrent urinary tract infections in women. BJU Int. 2022 Nov;130 Suppl 3(Suppl 3):11-22. doi: 10.1111/bju.15756. Epub 2022 May 17.
- Guay DR. Cranberry and urinary tract infections. Drugs. 2009;69(7):775-807. doi: 10.2165/00003495-200969070-00002.
- Scholes D, Hooton TM, Roberts PL, Stapleton AE, Gupta K, Stamm WE. Risk factors for recurrent urinary tract infection in young women. J Infect Dis. 2000 Oct;182(4):1177-82. doi: 10.1086/315827. Epub 2000 Aug 31.
- Wan X, Wu C, Xu D, Huang L, Wang K. Toileting behaviours and lower urinary tract symptoms among female nurses: A cross-sectional questionnaire survey. Int J Nurs Stud. 2017 Jan;65:1-7. doi: 10.1016/j.ijnurstu.2016.10.005. Epub 2016 Oct 21.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Disease Attributes
- Infections
- Recurrence
- Pathological Conditions, Signs and Symptoms
- Reinfection
- Inflammation
- Urinary Tract Infections
Other Study ID Numbers
- CS2-23025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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