Effect of Pollen Extract on Urinary Incontinence

Dr. Santiago Palacios

Status and phase: Completed; Phase 3

Conditions: Urinary Incontinence

Treatments: Dietary Supplement: Pollen extract

Study type: Interventional

Funder types: Other

Identifiers

NCT03438422

PJK-W10

Details and patient eligibility

About

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

Enrollment: 160 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 4 patient groups, including a placebo group

GROUP A

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Pollen extract

GROUP B

Active Comparator group

Description:

1 tablet a day of pollen B extract containing (140 mg aqueous extract and lipid 8 mg of purified pollen)

Treatment:

Dietary Supplement: Pollen extract

GROUP C

Active Comparator group

Description:

1 tablet a day of pollen extract C containing (Pollen extract 160 mg, pumpkin seed extract, 300 mg and Vitamin E 10 mg)

Treatment:

Dietary Supplement: Pollen extract

PLACEBO

Placebo Comparator group

Description:

1 tablet a day of placebo

Treatment:

Dietary Supplement: Pollen extract