Benigh Prosatic Hyperplasia/Lower Urinary Tract Symptoms

NCT05288621 | Unknown DMC

• 1 other identifier: 3rdZhejiangCMU
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

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

Keywords

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms; electroacupuncture; four sacral points

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• the Change From Baseline in the Overactive Bladder Symptom Score(OABSS)

  week4; week 8

• the Change From Baseline in the Quality of Life Score(QOL)

  week4; week 8

• the Change From Baseline in the Prostate Volume(PV)

  week4; week 8

• the Change From Baseline in the Post-Void Residual(PVR)

  week4; week 8

Study Arms (2)

electroacupuncture at'four sacral points'

EXPERIMENTAL

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.

Device: electroacupuncture

conventional electroacupuncture

ACTIVE COMPARATOR

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.

Device: electroacupuncture

Interventions

electroacupuncture 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.

Also known as: Acupuncture

conventional electroacupuncture; electroacupuncture at'four sacral points'

Eligibility Criteria

• Age: 40 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Related 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 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.

  PMID: 12559262 RESULT

• 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.

  PMID: 33315535 RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Electroacupuncture; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Jie Zhou

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Zhou

CONTACT

15968895450; zhoujie0111@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 21, 2022
• Study Start: April 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share