Benigh Prosatic Hyperplasia/Lower Urinary Tract Symptoms

Benign Prostatic Hyperplasia Clinical Trial

— BPH/LUTS  

Official title:

Electroacupuncture at "Four Sacral Points" for Benigh Prosatic Hyperplasia/Lower Urinary Tract Symptoms: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05288621
• Other study ID #: 3rdZhejiangCMU
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2022
• Source: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Contact: Jie Zhou
• Phone: 15968895450
• Email: zhoujie0111[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Device:
• electroacupuncture
For'four sacral points'group, Hua Tuo brand disposable acupuncture needles (size 0.40 × 100mm) and electronic needle therapy instrument SDZ-IIB will be used.Bilateral BL30 and BL35, were selected as acupoints protocol. 'Four sacral points'group consists of 8 sessions over an 4-week period after baseline(2 sessions in each week), each for 30minutes. The electroacupuncture will be set at a frequency of 2.0 Hz, continuous wave, a moderate intensity the patient can tolerate and 30 min during each treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Third Affiliated hospital of Zhejiang Chinese Medical University

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Change From Baseline in the International Prostate Symptom Score (IPSS)	IPSS is a valid, reliable and sensitive measure for patients with lower urinary tract symptoms; it iswidely used in clinical practice and research to determine the severity of lower urinary tractsymptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency,weak urine stream, straining and nocturia. Each of the questions is rated from 0 (not at all) to 5(almost always). IPSS score ranges from 0 to 35, with higher score indicating more severe urinary symptoms.Significant effect was defined as most of the major symptoms and signs disappeared, and the score decreased between 60% and 89%.; Effective is that the main symptoms and signs disappear partially, and the score decreases by 30%-59%.	week4; week 8
Secondary	the Change From Baseline in the Overactive Bladder Symptom Score(OABSS)	OABSS is a valid self-assessment questionnaire, four questions were set according to OAB syndrome to determine the severity of OAB, which include daytime and nighttime urination frequency, urgency, urge incontinence. Score range is 0-15, with higher scores indicating increasing symptom severity.	week4; week 8
Secondary	the Change From Baseline in the Quality of Life Score(QOL)	The QOL score understands the subjective perception of BPH patients about the impact of their current symptoms on their quality of life and is divided into 7 levels, corresponding to a score of 0-6, with the higher the score the lower the patient's quality of life, mainly indicating the extent to which the patient suffers from LUTS.	week4; week 8
Secondary	the Change From Baseline in the Prostate Volume(PV)	Transabdominal urinary system B ultrasound examination, can understand whether the upper urinary tract water, expansion, prostate size, shape, whether hyperplastic glands burst into the bladder, the extent of burst, burst range, whether there is abnormal nodular echo, etc.. Then the anterior and posterior diameters, left and right diameters and upper and lower diameters of the prostate were measured respectively, and then the prostate volume was calculated according to the formula.	week4; week 8
Secondary	the Change From Baseline in the Post-Void Residual(PVR)	The measurement of PVR is basically the same as that of prostate volume. The three data of anterior and posterior diameters, upper and lower diameters and left and right diameters of residual urine were measured, and the residual urine volume was calculated according to the formula.	week4; week 8