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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Electroacupuncture on Benign Prostatic Hyperplasia

NCT05585450

Benign Prostatic Hyperplasia

RECRUITING NA

Evaluation of the Functional Outcomes After Bilateral, 3D Ultrasound-guided Focal Thermal Ablation of the Prostate Transition Zone, in Patients with Benign Prostatic Hyperplasia-related Obstruction

NCT06212453

Benign Prostatic Hyperplasia

RECRUITING PHASE2

Benigh Prosatic Hyperplasia/Lower Urinary Tract Symptoms

NCT05288621

Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms

UNKNOWN NA

Evaluation of the Water Vapor Thermal Therapy System for the Treatment of Benign Prostatic Hyperplasia

NCT06725212

Benign Prostatic Hyperplasia

RECRUITING NA

Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients

NCT01736033

Benign Prostate Hyperplasia

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

BPH Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy Lower Urinary Tract Symptom

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Moxibustion

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

Group Type EXPERIMENTAL

Moxibustion

Intervention Type PROCEDURE

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.

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No