Effectiveness of Phytotherapy (Uriphytol) Versus Tamsulosin in Management of Benign Prostatic Obstruction at Kilimanjaro Christian Medical Centre: A Randomized, Open-Label, Phase 2, Non-Inferiority Trial

Background: This study compared the effectiveness of Uriphytol, a phytotherapy from Cucurbita pepo and Curcuma longa, with Tamsulosin in managing benign prostatic obstruction (BPO).

Methods: This was a 6-months, parallel-designed, randomized, open-label, phase 2 non-inferiority trial conducted at Kilimanjaro Christian Medical Centre in Tanzania. It included men aged 40 years and above with benign prostatic features and prostatic specific antigen (PSA) density less than 0.15ng/mL2. Participants were block randomized using computer-generated numbers in sealed envelopes into intervention or control arms by a research assistant, receiving either Uriphytol 500mg three times daily or Tamsulosin 0.4mg once daily. The primary outcome was the change in the International Prostate Symptom Score (IPSS) with a 3-point non-inferiority margin. Secondary outcomes included changes in post-void residual volume (PVR) and change in International Index of Erectile Function (IIEF-5) score. Ethical clearance was sought from College Research Ethical committee of Kilimanjaro Christian Medical University College (PG.02/2023) and the trial was registered in Pan African Clinical Trials Registry before recruitment of first participant with registration number PACTR202304488683045, currently closed to new participants.

Findings: Between August 2023 and July 2024, 87 participants were recruited (43 in the intervention arm, 44 in the control arm), with 82 completing the study (40 on Uriphytol, 42 on Tamsulosin). Two participants in the intervention and one in the control arm experienced urine retention, and one participant in each arm was lost to follow-up. After 6 months, there was no significant difference in IPSS reduction, but Uriphytol showed a significant improvement in IPSS-related quality of life (QoL) [Uriphytol vs Tamsulosin, IPSS: 16.20 ±7.38 vs. 15.52 ±5.38, p=0.206; QoL: 5.45 ±0.99 vs. 4.81 ±1.17, p=0.0049]. No significant difference in PVR changes was noted, but erectile function improved significantly in the Uriphytol group (p=0.044).

Interpretation: Uriphytol was not inferior to Tamsulosin for managing BPO, offering better erectile function and quality of life.

Trial Registration: The trial was registered in Pan African Clinical Trials Registry before recruitment of first participant with registration number PACTR202304488683045.

Funding: There was no funding for this study.

Declaration of Interest: I/We declare no competing interests.

Ethical Approval: Ethical clearance was sought from College Research Ethical committee of Kilimanjaro Christian Medical University College (PG.02/2023).