Effect of Pollen Extract on Urinary Incontinence

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438422
• Other study ID #: PJK-W10
• Status: Completed
• Phase: Phase 3
• Start date: December 21, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: March 2019
• Source: Instituto Palacios
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Dietary Supplement:
• Pollen extract
1 tablet a day

Locations

Country	Name	City	State
Spain	Instituto Palacios	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Santiago Palacios

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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