Urinary Incontinence
Conditions
Brief summary
Study with food supplement to assess the eficacy of pollen extract on Urinary Incontinence
Interventions
DIETARY_SUPPLEMENTPollen extract
1 tablet a day
Sponsors
Dr. Santiago Palacios
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of the pollen extract on Urinary Incontinence | 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 |
Countries
Spain
Outcome results
None listed