Evaluation of the Impact of 3 Pollen Extracts in the Control of Urinary Incontinence in Women. Double-blind, Randomized, Placebo-controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Effect of the pollen extract on Urinary Incontinence
研究概览
简要总结
Study with food supplement to assess the eficacy of pollen extract on Urinary Incontinence
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Pollen extract (Dietary Supplement)
GROUP B
1 tablet a day of pollen B extract containing (140 mg aqueous extract and lipid 8 mg of purified pollen)
干预措施: Pollen extract (Dietary Supplement)
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)
干预措施: Pollen extract (Dietary Supplement)
PLACEBO
1 tablet a day of placebo
干预措施: Pollen extract (Dietary Supplement)
结局指标
主要结局
Effect of the pollen extract on Urinary Incontinence
时间窗: 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
次要结局
未报告次要终点
研究者
Dr. Santiago Palacios
Principal Investigator
Instituto Palacios