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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

A Pilot Study on Effectiveness and Safety of Moxibustion for Benign Prostate Hyperplasia With Lower Urinary Tract Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02051036
• Other study ID #: NC1307
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2019
• Source: Korean Medicine Hospital of Pusan National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Benign Prostatic Hypertrophy
• BPH
• Hyperplasia
• Hypertrophy
• Lower Urinary Tract Symptom
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Procedure:
• Moxibustion
In the moxibustion treatment group, 5 moxibustion points (bilateral SP6, LV3 and unilateral CV4) will be heated with indirect moxibustion (KangHwa, Korea). The moxa pillars will be removed when the patient feel hotness and require to remove them. The moxibustion will be conducted repeatedly unless patients feel the sense of heat up to seven times per session.

Locations

Country	Name	City	State
Korea, Republic of	National Clinical Research Center, Korean Medicine Hospital, Pusan National University	Yangsa	Kyungsangnamdo

Sponsors (1)

Lead Sponsor	Collaborator
JUNGNAM KWON

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International prostate symptom score (IPSS) at 4 weeks		four weeks after randomization
Secondary	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
Secondary	Maximum flow rate by uroflowmetry (Qmax)		Baseline and 12 weeks after randomization (both group)
Secondary	Post-voiding residual urine in bladder (PVR)		Baseline and 12 weeks after randomization
Secondary	Changing Process and Persistence of International Prostate Symptom Score (IPSS)		2 weeks, 12 weeks after randomization
Secondary	recruitment rate		31-December-2015
Secondary	compliance rate	the attendance rate for treatment phase in integrative group, and for three major assessments (baseline, visit 9 and visit 10)	after 12 weeks
Secondary	retention rate	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.	after four weeks, after 12 weeks
Secondary	adverse events	patients will be asked if adverse effects have developed	visit 1,2,3,4,5,6,7,8,9 in experimental group ; visit 1,8,9 in control group