Evaluating Pumpkin Seed Oil Extract Supplementation on Bladder Function

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.

OBJECTIVES: Null hypothesis - Ingesting 1000mg daily of Cucurbita pepo pumpkin seed oil extract leads to no change in patient-reported bladder function reflected through Lower Urinary Tract Dysfunction Network Symptom Index-10 (LURN-SI) survey scores between their baseline assessment and at 12 weeks of supplement use. Primary Objective: 1\. Assess changes in patient-reported bladder function reflected through their responses on the LURN-SI survey. Secondary Objectives: 1. Assess rapid changes in patient-reported bladder function reflected through their responses on the LURN-SI survey following 4 weeks of supplement use. 2. Assess changes in patient-reported pelvic floor control reflected through their responses on the Pelvic Pain and Urgency/Frequency (PUF) questionnaire. 3. Assess patient willingness to continue with supplement use via responses on the Medication Adherence Questionnaire (MAQ). 4. Assess for any relationships in changes in patient bladder function or pumpkin seed extract adherence with their experience using complementary and alternative medicine. BACKGROUND: Overactive bladder (OAB) describes a change in bladder function with more frequent and urgent trips to the bathroom to urinate that interfere with the patient's quality of life. Patients with OAB experience urinary frequency, urgency, and leakage, and the 2011 EpiLUTS study estimated 33% women in the United States experience bothersome OAB.1 OAB adversely impacts quality-of-life and incurs almost $7 billion USD in healthcare-related costs annually within the United States, with costs being up to 5 times greater for women than men.2-4 The additional costs of items such as continence sanitary products may be prohibitive, which likely disproportionately impacts socially vulnerable patients.5,6 Despite significant efforts previous invested into evaluating causes for OAB and in developing treatments, the exact mechanism for OAB remains poorly understood and the side effects from pharmacologic treatment can be frustrating. As a result, certain patients opt to manage their OAB through complementary and alternative medicine (CAM).7 This includes use of nutritional supplement products. One study found that one online vendor carried 147 products marketed as supporting bladder health which contained 65 distinct supplements, and over 50% of products listed pumpkin seed extract as an ingredient.8 However, the exact mechanism for how pumpkin seed oil extract supports bladder function remains poorly understood. Limited animal study data suggest ingestion of pumpkin (Cucurbita) seed oil extract is associated with increased bladder compliance on urodynamic studies and decreased urinary frequency.9,10 It is posited that the high arginine levels found in pumpkin seeds drive nitric oxide production via the arginine nitric oxide pathway which subsequently contribute to findings of bladder relaxation. The utility of pumpkin seed oil is further explored in the management of benign prosta trial.show_full_description

Inclusion Criteria: * 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. Exclusion Criteria: * 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