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Effect of Pollen Extract on Urinary Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438422
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Santiago Palacios, Instituto Palacios

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

Condition or disease Intervention/treatment Phase
Urinary Incontinence Dietary Supplement: Pollen extract Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Evaluation of the Impact of 3 Pollen Extracts in the Control of Urinary Incontinence in Women. Double-blind, Randomized, Placebo-controlled Study
Actual Study Start Date : December 21, 2017
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Bee pollen

Arm Intervention/treatment
Experimental: GROUP A
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
1 tablet a day

Active Comparator: GROUP B
1 tablet a day of pollen B extract containing (140 mg aqueous extract and lipid 8 mg of purified pollen)
Dietary Supplement: Pollen extract
1 tablet a day

Active Comparator: GROUP C
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
1 tablet a day

Placebo Comparator: PLACEBO
1 tablet a day of placebo
Dietary Supplement: Pollen extract
1 tablet a day




Primary Outcome Measures :
  1. Effect of the pollen extract on Urinary Incontinence [ Time Frame: Baseline, two and three months ]
    To evaluate the effect of different pollen extracts on the number of leaks and on the amount of urine in each escape



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438422


Locations
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Spain
Instituto Palacios
Madrid, Spain, 28009
Sponsors and Collaborators
Dr. Santiago Palacios

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Responsible Party: Dr. Santiago Palacios, Principal Investigator, Instituto Palacios
ClinicalTrials.gov Identifier: NCT03438422     History of Changes
Other Study ID Numbers: PJK-W10
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders