Evaluating Pumpkin Seed Oil Extract Supplementation on Bladder Function

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNorthwestern University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Pumpkin Seed Extract

    Dietary supplement

    This is the only intervention

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Taking pumpkin seed extractExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

LURN-SI

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

Time frame
12 weeks

Secondary outcomes

1

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.

Time frame
4 weeks
2

PUF Questionnaire

Assess changes in patient-reported pelvic floor control reflected through their responses on the Pelvic Pain and Urgency/Frequency (PUF) questionnaire.

Time frame
12 weeks
3

Supplement Adherence

Assess patient willingness to continue with supplement use via responses on the Medication Adherence Questionnaire (MAQ).

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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