NCT03438422

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

9 months

First QC Date

February 8, 2018

Last Update Submit

March 22, 2019

Conditions

Urinary Incontinence

Outcome Measures

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

    Baseline, two and three months

Study Arms (4)

GROUP A

EXPERIMENTAL

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

GROUP B

ACTIVE COMPARATOR

1 tablet a day of pollen B extract containing (140 mg aqueous extract and lipid 8 mg of purified pollen)

Dietary Supplement: Pollen extract

GROUP C

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

1 tablet a day of placebo

Dietary Supplement: Pollen extract

Interventions

Pollen extractDIETARY_SUPPLEMENT

1 tablet a day

GROUP AGROUP BGROUP CPLACEBO

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Palacios

Madrid, 28009, Spain

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Propolis

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Resins, PlantBiopolymersPolymersMacromolecular SubstancesPlant ExudatesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2018

First Posted

February 19, 2018

Study Start

December 21, 2017

Primary Completion

September 30, 2018

Study Completion

November 30, 2018

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations

ES(1)