Moxibustion as an Adjuvant for Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms: a Pilot Study

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia; Lower Urinary Tract Symptom; BPH; Benign Prostatic Hypertrophy
• Interventions: Procedure: Moxibustion

• Registration Number: NCT02051036
• Lead Sponsor: JUNGNAM KWON

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 Timeline

• Study First Submitted: 2014-01-26
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-31
• Study Start: 2014-02
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-07
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

1. Male patients aged 20-80 years diagnosed with BPH with a prostate size over 20 gm
2. greater than or equal to eight score on IPSS
3. submit written consent
4. who can understand and answer IPSS.

Exclusion Criteria

1. prostate or bladder malignancy
2. received herbal medication for lower urinary tract symptoms within 1 week
3. history of brain disease could cause urinary difficulty
4. having problems on answering IPSS due to cognitive impairment.
5. signs of acute urinary tract infection
6. Diabetic mellitus
7. Neurogenic bladder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxibustion	Moxibustion	A series of moxibustion sessions within four weeks from the baseline with concurrent conventional medications for BPH.

Primary Outcome Measures

Name	Time	Method
International prostate symptom score (IPSS) at 4 weeks	four weeks after randomization

Secondary Outcome Measures

Name	Time	Method
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	patients will be asked if adverse effects have developed
retention rate	after four weeks, after 12 weeks	the ratio of 1) the number of patients who attend at the primary outcome assessment after four weeks versus the number of total participants, 2) the number of patients who attend the final assessment after 12 weeks versus the number of total participants, 3) the number of patients who returned the frequency-volume chart (FVC) versus the number of total participants.
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	the attendance rate for treatment phase in integrative group, and for three major assessments (baseline, visit 9 and visit 10)

Trial Locations

Locations (1)

National Clinical Research Center, Korean Medicine Hospital, Pusan National University; 🇰🇷 Yangsa, Kyungsangnamdo, Korea, Republic of