Status:
COMPLETED
Effect of Pollen Extract on Urinary Incontinence
Lead Sponsor:
Dr. Santiago Palacios
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
Study with food supplement to assess the eficacy of pollen extract on Urinary Incontinence
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2018
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03438422
Start Date
December 21 2017
End Date
November 30 2018
Last Update
March 25 2019
Active Locations (1)
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1
Instituto Palacios
Madrid, Spain, 28009