Clinical trial NCT05288621: Benigh Prosatic Hyperplasia/Lower Urinary Tract Symptoms
Official title: Electroacupuncture at "Four Sacral Points" for Benigh Prosatic Hyperplasia/Lower Urinary Tract Symptoms: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Keywords: Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
electroacupuncture
four sacral points
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 82
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Benign prostatic hyperplasia (BPH) is a common condition in aging men that is frequently associated with troublesome lower urinary tract symptoms (LUTS) which can be divided into storage phase symptoms (urinary frequency, urinary urgency, increased nocturia, urinary incontinence, etc.), voiding phase symptoms (interruption of urination, thinning of the urine line, straining to urinate, etc.), and post-void symptoms (incomplete sensation of urination, dribbling after urination, etc.).BPH is prevalent in as many as 40% of men in their fifties and 90% of men in their eighties.Yet, few effective therapiesare available for treating BPH/LUTS.

Acupuncture may be an effective treatment option for BPH/LUTS.However, effects of acupuncture on BPH/LUTS remain uncertain because of the small sample sizes or other methodological limitations.

The objective of this randomized,conventional electroacupuncture-controlled trial is to assess the effectiveness of electroacupuncture at'four sacral points'for relieving symptoms of BPH/LUTS. The results will provide a robust conclusion with a highlevel of evidence.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of BPH in accordance with the criteria of the Chinese Urological Diagnosis and Treatment Guidelines 2014 edition.
* Male patients aged 40-80 years.
* Not on any 5a-reductase inhibitor, a1 receptor blocker or traditional Chinese medicine in the past two weeks.
* International Prostate Symptom Score (IPSS) scores range from 1 to 19.
* Family members or patients give informed consent and sign informed consent.

Exclusion Criteria:

* Patients with recurrent urinary tract infections.
* Patients with neurogenic bladder and urethral stricture, bladder tumor and prostate cancer.
* Patients with benign prostatic obstruction who have failed invasive treatment.
* Patients with serious cardiovascular and cerebrovascular diseases, hematopoietic system and other primary diseases and mental disorders.
* Patients who are participating in other clinical trials or who are participating in other clinical trials within one month.

Primary outcomes:
measure: the Change From Baseline in the International Prostate Symptom Score (IPSS)
timeFrame: week4; week 8
Secondary outcomes:
measure: the Change From Baseline in the Overactive Bladder Symptom Score(OABSS)
timeFrame: week4; week 8
measure: the Change From Baseline in the Quality of Life Score(QOL)
timeFrame: week4; week 8
measure: the Change From Baseline in the Prostate Volume(PV)
timeFrame: week4; week 8
measure: the Change From Baseline in the Post-Void Residual(PVR)
timeFrame: week4; week 8
Other outcomes:
Locations:
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Jie Zhou
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
citation: Abrams P. Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline Amendment 2020. Letter. J Urol. 2021 Mar;205(3):938. doi: 10.1097/JU.0000000000001558. Epub 2020 Dec 14. No abstract available.