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Effect of Pollen Extract on Urinary Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438422
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Santiago Palacios, Instituto Palacios

Tracking Information
First Submitted Date  ICMJE February 8, 2018
First Posted Date  ICMJE February 19, 2018
Last Update Posted Date March 25, 2019
Actual Study Start Date  ICMJE December 21, 2017
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
Effect of the pollen extract on Urinary Incontinence [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Pollen Extract on Urinary Incontinence
Official Title  ICMJE Evaluation of the Impact of 3 Pollen Extracts in the Control of Urinary Incontinence in Women. Double-blind, Randomized, Placebo-controlled Study
Brief Summary Study with food supplement to assess the eficacy of pollen extract on Urinary Incontinence
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Urinary Incontinence
Intervention  ICMJE Dietary Supplement: Pollen extract
1 tablet a day
Study Arms  ICMJE
  • Experimental: 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)
    Intervention: Dietary Supplement: Pollen extract
  • Active Comparator: GROUP B
    1 tablet a day of pollen B extract containing (140 mg aqueous extract and lipid 8 mg of purified pollen)
    Intervention: Dietary Supplement: Pollen extract
  • Active Comparator: 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)
    Intervention: Dietary Supplement: Pollen extract
  • Placebo Comparator: PLACEBO
    1 tablet a day of placebo
    Intervention: Dietary Supplement: Pollen extract
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2018)
160
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 30, 2018
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Women
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03438422
Other Study ID Numbers  ICMJE PJK-W10
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dr. Santiago Palacios, Instituto Palacios
Study Sponsor  ICMJE Dr. Santiago Palacios
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Instituto Palacios
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP