Benigh Prosatic Hyperplasia/Lower Urinary Tract Symptoms

NCT ID: NCT05288621

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-12-30

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.

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

electroacupuncture at'four sacral points'

The participants in the electroacupuncture at'four sacral points'group will receive treatment that consists of 8 acupuncture sessions over an 4-week period after baseline (2 sessions in each week), each for 30 minutes. Hua Tuo brand disposable acupunctureneedles (size 0.40 × 100mm) and electronic needle therapy instrument SDZ-IIB will be used.The device will be set at a frequency of 2.0 Hz, continuous wave and a moderate intensity the patient can tolerate. Electrostimulation will be performed for 30 min during each treatment. BL30 (Baihuanshu )(both sides and BL35 (Huiyang )(both sides), were selected as acupoints protocol.BL30 is located on either side of the sacrococcygeal joint, approximately 1 cm from the joint. BL35 is in the buttock region, 0.5 cun lateral to the extremity of the coccyx.

Group Type: EXPERIMENTAL

electroacupuncture

Intervention Type: DEVICE

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.

conventional electroacupuncture

The participants in the conventional electroacupuncture group will select RN3 (Zhongji), CV4 (Guanyuan), and ST28 (Shuidao, both sides), KL3 (Taixi).A needle measuring 0.25×40 mm will be inserted perpendicularly to a depth of 25- 40 mm to RN3, CV4 and ST28 and 0.5 cun to KL3 to induce a local sensation (distention or sourness).Subsequently, the electrodes from the SDZ-IIB electroacupuncture device will be connected to the needles at these points, with the anode connected to ST28 and RN3, the cathode connected to ST28 and CV4. The protocol includes the same duration, frequency of sessions and the parameter setting of electroacupuncture as for the'four sacral points'treatment.

Group Type: ACTIVE_COMPARATOR

electroacupuncture

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Acupuncture

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Third Affiliated hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jie Zhou

Deputy Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jie Zhou

Role: PRINCIPAL_INVESTIGATOR

The Third Affiliated hospital of Zhejiang Chinese Medical University

Central Contacts

Jie Zhou

Role: CONTACT

zhoujie0111@163.com

15968895450

References

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.

Reference Type: RESULT

PMID: 12559262 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33315535 (View on PubMed)

Other Identifiers

3rdZhejiangCMU

Identifier Type: -

Identifier Source: org_study_id