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

JUNGNAM KWON

Status: Completed

Conditions: Benign Prostatic Hypertrophy; Benign Prostatic Hyperplasia; Lower Urinary Tract Symptom; BPH

Treatments: Procedure: Moxibustion

Study type: Interventional

Funder types: Other

Identifiers

NCT02051036

NC1307

Details and patient eligibility

About

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).

Full 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.

Enrollment: 25 patients

Sex: Male

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Moxibustion

Experimental group

Description:

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

Treatment:

Procedure: Moxibustion

Waiting

No Intervention group

Description:

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).