Nettle and Cranberry Capsules for Prevention of Urinary Tract Infection

Study Overview
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Brief Summary
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This study investigates whether the oral intake of a nettle and cranberry complex capsule may prevent recurrent urinary tract infection (rUTI). Participants will be aged between 30 - 75 years of age, with confirmed diagnosis of UTI status. The participants will be assessed for several parameters and asked to take 2 nettle and cranberry complex capsules twice daily for 8 weeks. The parameters will include international prostate symptoms score (IPSS), overactive bladder symptom score (OABSS), international consultation on incontinence questionnaire - overactive bladder (ICIQ-OAB), 3-day bladder diary (3dBD), and urine routine.

Detailed Description
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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.

Official Title
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Clinical Trial of Nettle and Cranberry Capsules for Prevention of Urinary Tract Infection

Conditions
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Urinary Tract Infection

Intervention / Treatment
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* Dietary Supplement: Nettle and Cranberry complex capsules
* Dietary Supplement: Placebo(starch)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Subjects will take two capsule of containing starch, twice a daily for 8 weeks. | Dietary Supplement: Placebo(starch)<br>* A specific capsule product, containing starch will be given to participants for oral intake for 8 weeks.<br>|
| Experimental: Treatment<br>Subjects will take two capsule of containing nettle and cranberry complex, twice a daily for 8 weeks. | Dietary Supplement: Nettle and Cranberry complex capsules<br>* A specific capsule product, containing nettle and cranberry complex will be given to participants for oral intake for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UTI-free duration in 8 weeks | 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. | on baseline and 8 weeks | 
| UTI recurrent incidence in 8 weeks | UTI episodes during 8 weeks treatment for each subject | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) Change from Baseline | 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. | on baseline,4 weeks and 8 weeks | 
| Overactive Bladder Symptom Score (OABSS) Change from Baseline | 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. | on baseline,4 weeks and 8 weeks | 
| International Consultation on Incontinence Questionnaire Overactive Bladder Score (ICIQ-OAB) Change from Baseline | 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 | 
| Bladder diary | Assessment of number of voids, number of leakages, and post void residual. | on baseline,4 weeks, and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nettle, Cranberry, Prevention, Urinary Tract Infection, Recurrent Infection, Inflammation