About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Pumpkin Seed Extract
Dietary supplementThis is the only intervention
Treatment groups
Trial outcomes
Primary outcomes
LURN-SI
Assess changes in patient-reported bladder function reflected through their responses on the LURN-SI survey.
Secondary outcomes
Rapid change in LURN-SI
Assess rapid changes in patient-reported bladder function reflected through their responses on the LURN-SI survey following 4 weeks of supplement use.
PUF Questionnaire
Assess changes in patient-reported pelvic floor control reflected through their responses on the Pelvic Pain and Urgency/Frequency (PUF) questionnaire.
Supplement Adherence
Assess patient willingness to continue with supplement use via responses on the Medication Adherence Questionnaire (MAQ).
Sponsors and contacts
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