A Pilot Study on Effectiveness and Safety of Moxibustion for Benign Prostate Hyperplasia With Lower Urinary Tract Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- International prostate symptom score (IPSS) at 4 weeks
Study Overview
Brief Summary
This study aims to explore the feasibility of moxibustion as a supplementary intervention and to assess the sample size for verifying the effectiveness and safety of integrative treatment involving moxibustion compared with conventional treatment for patients with benign prostate hyperplasia (BPH) accompanying moderate to severe lower urinary tract symptoms (LUTS).
Detailed Description
Patients who diagnosed as BPH with moderate to severe LUTS aged 20 to 80 years old will be divided into two groups, one is moxibustion plus conventional therapy group and the other is conventional therapy group.
Patients who belong to moxibustion plus conventional therapy group will be treated moxibustion for eight times by a Korean Medicine doctor with conventional therapy by a urologist.
Patients who belong to conventional therapy group will be treated with conventional therapy only, and they can receive moxibustion therapy after the clinical trial is finished.
IPSS, post void residual volume (PVR) and peak urine flow (Qmax) will be checked to evaluate the effectiveness and safety.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male patients aged 20-80 years diagnosed with BPH with a prostate size over 20 gm
- •greater than or equal to eight score on IPSS
- •submit written consent
- •who can understand and answer IPSS.
Exclusion Criteria
- •prostate or bladder malignancy
- •received herbal medication for lower urinary tract symptoms within 1 week
- •history of brain disease could cause urinary difficulty
- •having problems on answering IPSS due to cognitive impairment.
- •signs of acute urinary tract infection
- •Diabetic mellitus
- •Neurogenic bladder
Arms & Interventions
Moxibustion
A series of moxibustion sessions within four weeks from the baseline with concurrent conventional medications for BPH.
Intervention: Moxibustion (Procedure)
Waiting
Participants who will be allocated to waitlist will receive no moxibustion treatments throughout the 4 weeks while receiving other conventional managements for BPH. After 4 weeks, if participants choose to try the moxibustion treatment, the active acupuncture treatment will be provided for 4 weeks (2 sessions/week).
Outcomes
Primary Outcomes
International prostate symptom score (IPSS) at 4 weeks
Time Frame: four weeks after randomization
Secondary Outcomes
- Patient's global impression of change (PGIC)(visit 2,3,4,5,6,7,8, 9 in experimental group, visit 8,9 in control group)
- adverse events(visit 1,2,3,4,5,6,7,8,9 in experimental group ; visit 1,8,9 in control group)
- retention rate(after four weeks, after 12 weeks)
- Maximum flow rate by uroflowmetry (Qmax)(Baseline and 12 weeks after randomization (both group))
- Post-voiding residual urine in bladder (PVR)(Baseline and 12 weeks after randomization)
- Changing Process and Persistence of International Prostate Symptom Score (IPSS)(2 weeks, 12 weeks after randomization)
- recruitment rate(31-December-2015)
- compliance rate(after 12 weeks)
Investigators
JUNGNAM KWON
Professor
Korean Medicine Hospital of Pusan National University