Effect of Pollen Extract on Urinary Incontinence

• ClinicalTrials.gov Identifier: NCT03438422
• Recruitment Status: Completed
• First Posted: February 19, 2018
• Last Update Posted: March 25, 2019
• Sponsor: Dr. Santiago Palacios
• Information provided by (Responsible Party): Dr. Santiago Palacios, Instituto Palacios

Tracking Information

• First Submitted Date: February 8, 2018
• First Posted Date: February 19, 2018
• Last Update Posted Date: March 25, 2019
• Actual Study Start Date: December 21, 2017
• Actual Primary Completion Date: September 30, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Pollen Extract on Urinary Incontinence
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Other
• Condition: Urinary Incontinence

Intervention

Dietary Supplement: Pollen extract

1 tablet a day

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 16, 2018): 160
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 30, 2018
• Actual Primary Completion Date: September 30, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Women

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT03438422
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Current Responsible Party: Dr. Santiago Palacios, Instituto Palacios
• Original Responsible Party: Same as current
• Current Study Sponsor: Dr. Santiago Palacios
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Instituto Palacios
• Verification Date: March 2019