NCT02051036

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

January 26, 2014

Last Update Submit

April 7, 2019

Conditions

BPHBenign Prostatic HyperplasiaBenign Prostatic HypertrophyLower Urinary Tract Symptom

Keywords

moxibustion

Outcome Measures

Primary Outcomes (1)

  • International prostate symptom score (IPSS) at 4 weeks

    four weeks after randomization

Secondary Outcomes (8)

  • 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

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Moxibustion

EXPERIMENTAL

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

Procedure: Moxibustion

Waiting

NO INTERVENTION

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).

Interventions

MoxibustionPROCEDURE

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.

Moxibustion

Eligibility Criteria

Age20 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Clinical Research Center, Korean Medicine Hospital, Pusan National University

Yangsa, Kyungsangnamdo, 626-770, South Korea

Location

Related Publications (1)

  • Lee HY, Nam JK, Lee SD, Lee DH, Han JY, Yun YJ, Lee JH, Park HL, Park SH, Kwon JN. Moxibustion as an adjuvant for benign prostatic hyperplasia with lower urinary tract symptoms: a protocol for a parallel-group, randomised, controlled pilot trial. BMJ Open. 2015 Dec 11;5(12):e008338. doi: 10.1136/bmjopen-2015-008338.

    PMID: 26656981DERIVED

MeSH Terms

Conditions

Prostatic HyperplasiaLower Urinary Tract Symptoms

Interventions

Moxibustion

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeutics

Study Officials

  • Jung Nam Kwon, PhD

    Korean Medicine Hospital, Pusan National University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 26, 2014

First Posted

January 31, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 9, 2019

Record last verified: 2019-04

Locations

KR(1)