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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

Browse trials for

03

In context

Urinary Incontinence

983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.

This study's enrollment of 160 is above the median of 66 across 739 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Dr. Santiago Palacios is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 or immunodeficiency (including 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

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

06

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

07

Study locations

1 site
  • Instituto Palacios
    Madrid, 28009, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Sep 2018, 9 months.

Of 30 phase 3 interventional studies under Urinary Incontinence, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's 9 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 8, 2018
First posted
Feb 19, 2018
StartActual
Dec 21, 2017
Primary completionActual
Sep 30, 2018
CompletionActual
Nov 30, 2018
Last update
Mar 25, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

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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Discussion

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