Pumpkin Seed Extract for Overactive Bladder

Overseen By Julia Geynisman-Tan, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Overactive bladder medications

Disqualifiers: Pelvic organ prolapse, Neurogenic bladder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a pilot study to assess using validated outcome measures how ingesting pumpkin seed oil extract supports patient bladder function in a United States population.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you cannot start any new overactive bladder medications or supplements during the study or in the 3 months before joining.

What data supports the effectiveness of the treatment Pumpkin Seed Oil Extract for Overactive Bladder?

Research shows that pumpkin seed oil extract from Cucurbita maxima significantly improved symptoms of overactive bladder in humans, reducing the Overactive Bladder Symptom Score after 6 and 12 weeks of treatment. Additionally, studies on rabbits indicate that pumpkin seed oil can reduce bladder pressure and improve bladder function, supporting its potential benefits for urinary disorders. ^{1 2 3 4 5}

Is pumpkin seed extract safe for humans?

Pumpkin seed extract, including oil and hydroethanolic forms, has been used in studies for urinary and prostate conditions, showing good tolerability and no significant safety concerns in humans. ^{1 2 3 4 6}

How does pumpkin seed oil extract treatment differ from other treatments for overactive bladder?

Pumpkin seed oil extract is unique because it is a natural treatment derived from the seeds of the pumpkin plant, specifically Cucurbita maxima, and is taken orally. Unlike synthetic drugs, it works by reducing bladder pressure and improving bladder function, offering a plant-based alternative with good tolerability for managing overactive bladder symptoms. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for individuals with overactive bladder symptoms who are patients at Northwestern's IPHP. They must be willing to take a dietary supplement and not start other treatments for 12 weeks after beginning the pumpkin seed oil extract. People can't join if they have certain bladder issues, use similar supplements, don't speak English, or have had recent pelvic surgery.

Inclusion Criteria

I am willing to try a dietary supplement for my overactive bladder and not start other treatments for 12 weeks.

Exclusion Criteria

Urinary post-void residual ≥150cc

I am currently taking supplements that contain pumpkin seed oil.

Culture-proven urinary tract infection at enrollment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive 1000mg of pumpkin seed oil extract daily for 12 weeks

12 weeks

Initial visit for enrollment and questionnaire completion

Follow-up

Participants complete follow-up questionnaires to assess changes in bladder function and supplement adherence

12 weeks

Follow-up questionnaires at 4 weeks and 12 weeks

Treatment Details

Interventions

• Pumpkin Seed Oil Extract

Trial Overview The study is testing whether taking pumpkin seed oil extract as a dietary supplement improves bladder function in people with an overactive bladder. This pilot study will measure outcomes based on validated methods within a U.S. population.

Participant Groups

Group I: Taking pumpkin seed extract Experimental Treatment 1 Intervention

Upon a patient's enrollment into the study and completion of initial study questionnaires, a research team member will provide the patient with a single bottle of pumpkin seed oil extract. Enrolled patients will be instructed to initiate using the pumpkin seed oil extract starting the day they receive the supplement. Patients will start taking one pill by mouth per day for 12 weeks. They will also be advised to contact their urogynecologist for follow-up if they have not noticed improvement in their bladder health following 3 months of use. Furthermore, they will be counseled about not starting new medications or supplements during their time as a study participant and not sharing their pumpkin seed oil extract with anyone else during their time as a study participant.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Pumpkin Seed Oil Extracted From Cucurbita maxima Improves Urinary Disorder in Human Overactive Bladder. [2022]

2. China pubmed.ncbi.nlm.nih.gov

Effect of the extracts of pumpkin seeds on the urodynamics of rabbits: an experimental study. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Phytotherapy Adds to the Therapeutic Armamentarium for the Treatment of Mild-To-Moderate Lower Urinary Tract Symptoms in Men. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of an Oil-Free Hydroethanolic Pumpkin Seed Extract on Symptom Frequency and Severity in Men with Benign Prostatic Hyperplasia: A Pilot Study in Humans. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

[Phytotherapy of benign prostatic hyperplasia. Current evidence-based evaluation]. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Pumpkin seed extract: Cell growth inhibition of hyperplastic and cancer cells, independent of steroid hormone receptors. [2022]