Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Relief During Transperineal MRI-Ultrasound Fusion-Guided Prostate Biopsy: An Exploratory Single-Center, Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Pain intensity during transperineal prostate biopsy
研究概览
简要总结
The goal of this clinical trial is to learn whether transcutaneous electrical nerve stimulation (TENS) can reduce pain during transperineal prostate biopsy in adult male patients. It will also assess the safety and tolerability of using TENS in this setting. The main questions it aims to answer are:
Does TENS lower patient-reported pain during local anesthesia and prostate biopsy sampling?
Are there any side effects or complications associated with using TENS during the procedure?
Researchers will compare TENS to a placebo (sham TENS with no active stimulation) and to standard care (local anesthesia alone).
Participants will:
Be randomly assigned to receive either TENS + local anesthesia, sham TENS + local anesthesia, or local anesthesia alone
Undergo a standard transperineal prostate biopsy guided by MRI-ultrasound fusion
Report their pain levels during four specific stages of the procedure
Attend a follow-up visit 3-4 weeks after the biopsy to review results and assess for any side effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Suspicious lesions on multiparametric MRI, classified as PI-RADS score ≥ 3
- •The indication for mpMRI was based on the presence of at least one of the following:
- •Elevated serum prostate-specific antigen (PSA) levels
- •Abnormal digital rectal examination (DRE)
排除标准
- •Prior treatment of prostate cancer
- •Contraindications to TENS, including:
- •Cutaneous damage or dermatologic conditions at the TENS application sites
- •Presence of cardiac pacemakers or automatic implantable cardioverter-defibrillators (AICDs)
- •Uncontrolled cardiac arrhythmias or congestive heart failure
- •History of epilepsy or seizure disorders
- •Metal implants near the site of stimulation
- •Malignancy at or near the site of stimulation
- •Contraindications to transperineal biopsy, including:
- •Active urinary tract infection
- •Bleeding disorders or ongoing anticoagulant therapy
- •Anatomical abnormalities that prevent safe access to the prostate
- •Known allergy or intolerance to local anesthetics or biopsy-related materials
- •Severe comorbidities or unstable medical conditions that could compromise procedural safety
- •Inability to provide informed consent or refusal to sign the consent form
研究组 & 干预措施
A. Local Anesthesia Only (Control Group)
Participants receive standard local anesthesia for transperineal MRI-ultrasound fusion-guided prostate biopsy using 1% lignocaine (20 mL total). No additional intervention is applied.
干预措施: Local Anesthesia (Procedure)
B. TENS + Local Anesthesia
Participants receive transcutaneous electrical nerve stimulation (TENS) applied to the perineum in addition to standard local anesthesia.
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
B. TENS + Local Anesthesia
Participants receive transcutaneous electrical nerve stimulation (TENS) applied to the perineum in addition to standard local anesthesia.
干预措施: Local Anesthesia (Procedure)
C. Sham TENS + Local Anesthesia
Participants receive sham (inactive) TENS with standard local anesthesia. Electrodes are applied as in Group B, but no electrical stimulation is delivered.
干预措施: Sham Transcutaneous Electrical Nerve Stimulation (Sham TENS) (Device)
C. Sham TENS + Local Anesthesia
Participants receive sham (inactive) TENS with standard local anesthesia. Electrodes are applied as in Group B, but no electrical stimulation is delivered.
干预措施: Local Anesthesia (Procedure)
结局指标
主要结局
Pain intensity during transperineal prostate biopsy
时间窗: Immediately after each procedural stage (within 30 seconds)
Pain will be measured using the Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain) at four key stages of the procedure: (1) ultrasound probe insertion, (2) perineal skin infiltration, (3) peri-prostatic nerve block, and (4) biopsy sampling.
次要结局
- Incidence of adverse events related to biopsy or TENS application(Up to 30 days after biopsy)
- Participant perception of TENS activity (blinding assessment)(Immediately after the procedure)
- Correlation between number of biopsy cores and pain score(Immediately after biopsy sampling)
研究者
Bartłomiej Marczak
MD
Medical University of Gdansk