Urinary IncontinencePhase 3NCT03438422
Effect of Pollen Extract on Urinary Incontinence
A Phase 3 study testing Pollen extract in people with Urinary Incontinence, run by Dr. Santiago Palacios at 1 site in Spain.
Trial summary
Study with food supplement to assess the eficacy of pollen extract on Urinary Incontinence Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Pollen extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- 21 Dec 2017to 30 Nov 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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 with food supplement to assess the eficacy of pollen extract on Urinary Incontinence
- Conditions
- Urinary Incontinence
- Being tested
- Pollen extract
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pollen extractDietary supplement
1 tablet a day
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Dietary Supplement: Pollen extract |
| PLACEBO | Placebo comparator | 1 tablet a day of placebo Receives: Dietary Supplement: Pollen extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, two and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start21 Dec 2017
- Primary completion30 Sep 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Santiago Palacios
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Santiago Palacios, Instituto Palacios
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438422
- Sponsor's protocol ID
- PJK-W10
- Status last verified
- Mar 2019
- First submitted
- 8 Feb 2018
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of 3 Pollen Extracts in the Control of Urinary Incontinence in Women. Double-blind, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT03438422
- Acronym / sponsor ID
- PJK-W10
- Conditions
- Urinary Incontinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Dr. Santiago PalaciosUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study with food supplement to assess the eficacy of pollen extract on Urinary Incontinence
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GROUP A | Experimental | Dietary Supplement: Pollen extract1 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) |
| GROUP B | Active comparator | Dietary Supplement: Pollen extract1 tablet a day of pollen B extract containing (140 mg aqueous extract and lipid 8 mg of purified pollen) |
| GROUP C | Active comparator | Dietary Supplement: Pollen extract1 tablet a day of pollen extract C containing (Pollen extract 160 mg, pumpkin seed extract, 300 mg and Vitamin E 10 mg) |
| PLACEBO | Placebo comparator | Dietary Supplement: Pollen extract1 tablet a day of placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pollen extract1 tablet a day | Dietary supplement | GROUP A, GROUP B, GROUP C, PLACEBO |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pollen extract in people with Urinary Incontinence, run by Dr. Santiago Palacios at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the pollen extract on Urinary Incontinence (time frame: Baseline, two and three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.