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Effect of Pollen Extract on Urinary Incontinence

Primary Purpose

Urinary Incontinence

Status

Completed

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Pollen extract

About this trial

This is an interventional other trial for Urinary Incontinence

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Instituto Palacios

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

GROUP A

GROUP B

GROUP C

PLACEBO

Arm Description

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)

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

1 tablet a day of pollen extract C containing (Pollen extract 160 mg, pumpkin seed extract, 300 mg and Vitamin E 10 mg)

1 tablet a day of placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03438422

First Posted

February 8, 2018

Last Updated

March 22, 2019

Sponsor

Dr. Santiago Palacios

1. Study Identification

Unique Protocol Identification Number

NCT03438422

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

December 21, 2017 (Actual)

Primary Completion Date

September 30, 2018 (Actual)

Study Completion Date

November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr. Santiago Palacios

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence

7. Study Design

Primary Purpose

Other

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GROUP A

Arm Type

Experimental

Arm Description

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)

Arm Title

GROUP B

Arm Type

Active Comparator

Arm Description

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

Arm Title

GROUP C

Arm Type

Active Comparator

Arm Description

1 tablet a day of pollen extract C containing (Pollen extract 160 mg, pumpkin seed extract, 300 mg and Vitamin E 10 mg)

Arm Title

PLACEBO

Arm Type

Placebo Comparator

Arm Description

1 tablet a day of placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

Pollen extract

Intervention Description

1 tablet a day

Primary Outcome Measure Information:

Title

Effect of the pollen extract on Urinary Incontinence

Description

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

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Women

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Instituto Palacios

City

Madrid

ZIP/Postal Code

28009

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Effect of Pollen Extract on Urinary Incontinence

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