NOGO for an Overactive Bladder

Study Overview
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Brief Summary
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This is a double-blind, randomized and placebo-controlled study to evaluate the safety and effectiveness of NoGo, a standardized extract from Angelica archangelica, on overactive bladder

Official Title
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A Parallel, Randomised, Double Blind, Placebo Controlled Study to Investigate the Effect of NOGO on Overactive Bladder in Men and Women

Conditions
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Overactive Bladder, Nocturia

Intervention / Treatment
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* Drug: extract from Angelica archangelica leaf
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspected or diagnosed with overactive bladder (average ≥ of 1.5 nocturnal voids per night and/or less then 2 hours between voids at least half time of the day (question 2 IPSS) Exclusion Criteria: High alcohol consumption (males > 3 beers/day (36 g alcohol), females >2 beers/day -- (24 g alcohol), but we take weekly average. Abnormal urinary findings suggestive of urinary tract infection, significant hematuria or glucosuria requiring further evaluation. Chronic incontinence. Recurrent urinary tract infections (3 or more times per year). Pregnancy, lactation, last child born at least one year before, uterine prolapse, histerectomy Surgical treatment for bladder outlet obstruction/BPH performed within the past 6 months. Moderate to severe prostate hyperplasia (IPSS questionnaire). Medical history or active conditions which, in the opinion of the principal investigator (PI) and physicians participating in the study would prohibit participation in the study. This includes, but is not limited to: diabetes, cancer, renal failure, cirrhosis or chronic liver disease, pancreatic diseases, recent (<6 months) myocardial infarction or unstable coronary artery disease. Psychiatric diseases and medication. Use of NoGO or other products containing A. archangelica extract within the previous 2 months prior to randomisation. Known allergy to compound or any other ingredients of NoGo. Supplements like pumpkin seeds, natural products with diuretic effect. Not exclusion if they have a wash out period. Receipt of an investigational product within 30 days prior to enrolment or expected receipt during this study.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: Experimental<br> | Drug: extract from Angelica archangelica leaf<br>* A standardized extract from Angelica archangelica leaf. Capsule, Twice Daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of urination frequency (number of voids per 24 hours) | Reduction in number of voids per 24 hours as assessed by a 3 day voiding diary before and after treatment | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced number of daytime voids | Reduction in number of voids occurring during waking hours as assessed by a 3 day voiding diary before and after treatment | 6 weeks | 
| Reduced number of nocturnal voids (nocturia) | Reduction in number of voids occurring during sleeping hours as assessed by a 3 day voiding diary before and after treatment | 6 weeks | 
| Reduced number of nocturnal voids (nocturia) per hour sleeping time | Reduction in number of voids occurring during sleeping hours corrected by sleeping time as assessed by a 3 day voiding diary before and after treatment | 6 weeks | 
| Reduced number of voids occurring shortly after the last one | Reduction in number of voids occurring shortly after the preceding void (less than 60, 90 and 120 minutes) as assessed by a 3 day voiding diary before and after treatment | 6 weeks | 
| Improvement of the results of the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB) | Questionnaire assessing overactive bladder. Overall score is 0-16 with greater values indicating increased symptom severity | 6 weeks | 
| Improvement of the results of the The International Prostate Symptom Score (IPSS) | A questionnaire assessing prostate symptoms. Overall score is 0-35 (7 questions with score 0-5 each), with greater values indicating increased symptom severity | 6 weeks |