Effect of Pollen Extract on Urinary Incontinence

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

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

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Dietary supplement: Pollen extract

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28009
    • Instituto Palacios

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr. Santiago Palacios

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2017
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 22, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: PJK-W10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No