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
NCT number | NCT02051036 |
Other study ID # | NC1307 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2014 |
Est. completion date | December 2015 |
Verified date | April 2019 |
Source | Korean Medicine Hospital of Pusan National University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | National Clinical Research Center, Korean Medicine Hospital, Pusan National University | Yangsa | Kyungsangnamdo |
Lead Sponsor | Collaborator |
---|---|
JUNGNAM KWON |
Korea, Republic of,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04807296 -
Thulium Fiber Laser Enucleation of the Prostate (TFLEP) vs HoLEP With Moses Technology (m-HoLEP)
|
N/A | |
Recruiting |
NCT05574244 -
Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction
|
N/A | |
Recruiting |
NCT04288427 -
5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
|
N/A | |
Not yet recruiting |
NCT04245566 -
Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH
|
Phase 3 | |
Withdrawn |
NCT01967251 -
Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction
|
Phase 2 | |
Completed |
NCT03246880 -
Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients
|
Phase 3 | |
Completed |
NCT02509975 -
Safety and Efficacy of OCL 503 in Prostate Artery Embolization
|
N/A | |
Completed |
NCT02283684 -
GreenLight Laser Photoselective Vaporization of the Prostate vs Bipolar Transurethral Vaporization of the Prostate; RCT
|
Phase 4 | |
Completed |
NCT02206243 -
Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia
|
||
Completed |
NCT01454349 -
Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)
|
Phase 1/Phase 2 | |
Completed |
NCT01438775 -
Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
|
Phase 3 | |
Completed |
NCT01152190 -
A Study in Benign Prostatic Hyperplasia
|
Phase 3 | |
Completed |
NCT01139762 -
A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms
|
Phase 3 | |
Active, not recruiting |
NCT00400894 -
Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma
|
N/A | |
Completed |
NCT00224133 -
The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
|
Phase 3 | |
Unknown status |
NCT00381108 -
Study of the Effects of Pomegranate Tablets on Enlarged Prostates
|
Phase 1 | |
Completed |
NCT00701779 -
Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia
|
Phase 4 | |
Terminated |
NCT02962674 -
To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.
|
N/A | |
Active, not recruiting |
NCT05415748 -
Deprescribing Tamsulosin in Older Men
|
Phase 4 | |
Recruiting |
NCT04853914 -
Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.
|
N/A |