Electroacupuncture for lower urinary tract symptoms in men with benign prostatic hyperplasia: study protocol for a...

Area of Science:

• Urology
• Integrative and Complementary Medicine
• Clinical Trials

Background:

• Benign prostatic hyperplasia (BPH) is a prevalent condition in men over 40, causing lower urinary tract symptoms (LUTS) that impair quality of life.
• Acupuncture, specifically electroacupuncture (EA), is being explored as a potential therapeutic option for BPH-related LUTS, but its efficacy requires rigorous evaluation.
• Current treatment options for BPH and LUTS may have limitations or side effects, driving the need for alternative therapies like EA.

Purpose of the Study:

• To evaluate the efficacy and safety of electroacupuncture (EA) in alleviating lower urinary tract symptoms (LUTS) in men diagnosed with benign prostatic hyperplasia (BPH).
• To compare the effects of EA against sham electroacupuncture (SA) in a multicentre, randomized, controlled trial setting.
• To assess the impact of EA on the International Prostate Symptom Score (IPSS) over an 8-week treatment period and a subsequent 24-week follow-up.

Main Methods:

• A two-arm, sham-controlled, subject- and assessor-blinded randomized trial involving 306 male patients aged 40-80 with moderate to severe LUTS due to BPH.
• Participants will receive either EA or SA for 24 sessions over 8 weeks, followed by a 24-week follow-up period.
• The primary outcome measure is the proportion of participants achieving at least a 30% reduction in their total IPSS from baseline at weeks 8 and 20. Intention-to-treat analysis will be employed.

Main Results:

• Primary outcome data regarding the reduction in International Prostate Symptom Score (IPSS) at weeks 8 and 20 are being collected.
• Safety data on adverse events associated with electroacupuncture (EA) and sham electroacupuncture (SA) will be analyzed.
• Statistical significance will be determined using a two-tailed p-value less than 0.05.

Conclusions:

• The study is designed to provide robust evidence on the effectiveness and safety of electroacupuncture (EA) for benign prostatic hyperplasia (BPH).
• Findings are anticipated to inform clinical practice regarding the use of EA as a treatment for lower urinary tract symptoms (LUTS).
• Results will be disseminated through publication in a peer-reviewed journal.