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CompletedNCT03438422Updated Mar 25, 2019

Effect of Pollen Extract on Urinary Incontinence

A Phase 3 interventional study of Pollen extract in Urinary Incontinence, sponsored by Dr. Santiago Palacios. Completed at 1 site in Spain. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-25.

Sponsored by Dr. Santiago Palacios · Phase 3, Interventional, and Other

Phase
Phase 3
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

Study with food supplement to assess the eficacy of pollen extract on Urinary Incontinence

02

Conditions studied

  • Urinary Incontinence
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts 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

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
04

Study design

Phase
Phase 3
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
160 participants (actual)

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)

    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)

    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)

    Dietary Supplement: Pollen extract

  • Placebo comparator
    PLACEBO

    1 tablet a day of placebo

    Dietary Supplement: Pollen extract

Interventions

  • Dietary supplementPollen extract

    1 tablet a day

05

What researchers measure

Primary outcomes

  1. Effect of the pollen extract on Urinary Incontinence

    To evaluate the effect of different pollen extracts on the number of leaks and on the amount of urine in each escape

    Time frame: Baseline, two and three months

06

Study locations

1 site
  • Instituto Palacios
    Madrid, 28009, Spain
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03438422
Lead sponsor
Dr. Santiago Palacios
Responsible party
Dr. Santiago Palacios (Principal Investigator, Instituto Palacios) — Sponsor-investigator
First posted
Feb 19, 2018
Start date
Dec 21, 2017
Primary completion
Sep 30, 2018
Completion
Nov 30, 2018
Last update
Mar 25, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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