Evaluating Pumpkin Seed Oil Extract Supplementation on Bladder Function

NCT06944392 | Recruiting

• 1 other identifier: STU00221825
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overactive Bladder (OAB)

Outcome Measures

Primary Outcomes (1)

• LURN-SI

  Assess changes in patient-reported bladder function reflected through their responses on the LURN-SI survey.

  12 weeks

Secondary Outcomes (3)

• Rapid change in LURN-SI

  4 weeks

• PUF Questionnaire

  12 weeks

• Supplement Adherence

  12 weeks

Study Arms (1)

Taking pumpkin seed extract

EXPERIMENTAL

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.

Dietary Supplement: Pumpkin Seed Extract

Interventions

Pumpkin Seed Extract DIETARY_SUPPLEMENT

This is the only intervention

Taking pumpkin seed extract

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients evaluated at Northwestern's IPHP who report bladder function consistent with overactive bladder (urinary urgency, with or without urinary frequency more than 8 times daily or nocturia, with or without urgency urinary incontinence) at their index visit, who are also willing to use a dietary supplement and not initiate additional behavioral, medication or procedural treatment for 12 weeks following pumpkin seed oil extract initiation.

You may not qualify if:

• Patients with any of the following will be excluded from the study:
• Use of other supplements that contain pumpkin seed oil
• ≥Stage 3 pelvic organ prolapse
• Urinary post-void residual ≥150cc
• Culture-proven urinary tract infection at time of study enrollment
• Recurrent urinary tract infection
• Neurogenic bladder
• Abdominal or pelvic malignancy
• Initiation of new overactive bladder medications or supplements during study period or in the 3 months immediately preceding study enrollment
• History of surgery in the past 12 months for pelvic organ prolapse, stress urinary incontinence, urgency urinary incontinence, or fecal or flatal incontinence
• Patient's primary language is not English

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Julia Geynisman-Tan, MD

CONTACT

312-926-9929; Julia.Geynisman-Tan@nm.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: April 25, 2025
• Study Start: April 11, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)