Effect of Pollen Extract on Urinary Incontinence

Study Overview
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Brief Summary
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Study with food supplement to assess the eficacy of pollen extract on Urinary Incontinence

Official Title
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Evaluation of the Impact of 3 Pollen Extracts in the Control of Urinary Incontinence in Women. Double-blind, Randomized, Placebo-controlled Study

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Dietary Supplement: Pollen extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate, severe or very severe urinary incontinence, according to the severity index Incontinence Severity Index (ISI) * of Sandvik Healthy patients from 18 to 75 years of age Normal cytology in the last year and normal urological culture at inclusión Negative result in urine culture and normal vaginal canal (no evidence of dysplasia and / or infection) External vaginal area (vestibule and introitus) free of wounds or bleeding Exclusion Criteria: Surgery for urinary incontinence Acute or recurrent infections of the urinary tract or genital infections (herpes or candida) in the last 3 months Malignant neoplasm or history of neoplasia in the last 5 years Concomitant disease such as a cardiac disorder, uncontrolled type I or II diabetes, lupus porphyria, relevant neurological disorders, any disease that in the opinion of the doctor could interfere with the treatment or resolution of the disease Anticoagulant alteration or thromboembolic alteration or taking anticoagulant drugs one week before treatment or during treatment for possible drug interaction (to allow inclusion, temporary cessation of use at the discretion of the doctor) History of immunosuppression or immunodeficiency (including HIV infection or AIDS) or use of immunosuppressive medications Hormonal imbalance, related to the thyroid, hypophysis or androgen not controlled Having a significant alteration in the areas under treatment or inflammatory alterations including but not limited to lacerations, abrasions or ulcers prior to treatment (time of resolution at the discretion of the doctor) or during treatment Dysplastic nevus in the treatment área Prolapse grade II according to the classification of the Pelvic Organ Prolapse Quantification (ICS-POP-Q) System Kegel exercises or electrostimulation at least 30 days before the start of treatment are not allowed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GROUP A<br>1 tablet a day of pollen A extract containing (140 mg aqueous extract and 8mg lipid purified pollen, aqueous extract pumpkin seed 300mg, 10mg Vitamin E) | Dietary Supplement: Pollen extract<br>* 1 tablet a day<br>|
| Active Comparator: GROUP B<br>1 tablet a day of pollen B extract containing (140 mg aqueous extract and lipid 8 mg of purified pollen) | Dietary Supplement: Pollen extract<br>* 1 tablet a day<br>|
| Active Comparator: GROUP C<br>1 tablet a day of pollen extract C containing (Pollen extract 160 mg, pumpkin seed extract, 300 mg and Vitamin E 10 mg) | Dietary Supplement: Pollen extract<br>* 1 tablet a day<br>|
| Placebo Comparator: PLACEBO<br>1 tablet a day of placebo | Dietary Supplement: Pollen extract<br>* 1 tablet a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of the pollen extract on Urinary Incontinence | To evaluate the effect of different pollen extracts on the number of leaks and on the amount of urine in each escape | Baseline, two and three months |