Benign Prostatic Hyperplasia
Conditions
Brief summary
The aim is to assess the efficacy of a mix of Pumpkin Seed Extract, Soy Germ Isoflavonoids and Cranberry (Novex®) in the management of mild to moderate LUTS in BPH patients. The patients will be evaluated based on the severity of LUTS, urological quality of life, and erectile function.
Detailed description
This is a single-arm prospective open-label trial investigating a combination of pumpkin seed, isoflavonoid and cranberry mix in improving LUTS, urological quality of life, and erectile function in BPH patients. The compound will be administered orally two tablets daily for 3 months. Recruited patients will be seen at 3 visits: initial visit (visit 1), 1-month visit (visit 2) and 3-month visit (visit 3) and their data will be collected in a dedicated case report form.
Interventions
DRUGNovex
Novex® made of Pumpkin Seed Extract 550mg, Soy Germ Isoflavonoids 50 mg and Cranberry 50mg. The dose is 2 tablets/day taken orally.
Sponsors
Saint-Joseph University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* mild to moderate LUTS due to BPH for at least 6 months at the initial visit * no previous therapy or are still symptomatic despite the current use of alpha-blockers
Exclusion criteria
* International Prostate Symptom Score (IPSS) \> 19 * Prostate cancer * Urethral stenosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IPSS | At 1 and 3 months visits | Change in IPSS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IPSS subscores | At 1 and 3 months visits | Change in IPSS subscores (voiding, filling, nocturia) |
| uQoL | At 1 and 3 months visits | Change in uQoL |
| IIEF-5 | At 1 and 3 months visits | Change in IIEF-5 |
| Rate of ejaculatory dysfunction and orthostatic hypotension | At 1 and 3 months visits | Rate |
Countries
Lebanon
Outcome results
None listed