Evaluating a new therapy for benign prostatic hyperplasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the steep pulse therapy system for treating benign prostatic hyperplasia (BPH). Participants will either receive Tamsulosin Hydrochloride or undergo the steep pulse ablation procedure. The study will evaluate symptom management and safety concerns associated with steep pulse ablation compared to the standard medication. Follow-up assessments will occur at one and three months post-treatment to monitor outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. patients with BPH diagnosed through digital rectal examination, B-mode ultrasound and urinary flow rate.
2. international prostate symptom score(IPSS)\>=12.
3. Maximum urinary flow rate between \>5ml/s and \<15ml/s with a minimum voided volume ≥ 150ml.
4. Age ≥ 50 years old.
5. Subjects are willing to participate and have signed the informed consent form.

Exclusion Criteria:

1. Patients with acute or severe urinary tract infections.
2. Patients clinically diagnosed with prostate cancer.
3. Patients with neurogenic bladder or bladder dysfunction due to other factors.
4. Patients with urethral stricture.
5. Patients who have undergone previous prostatectomy (TURP), enucleation, or laser surgery.
6. Patients with implanted pacemakers or metal replacements in the pelvis or hip joints.
7. Patients who cannot tolerate general anesthesia or surgery due to severe systemic diseases, heart diseases, pulmonary insufficiency, failure of vital organs, or other reasons.
8. Patients in the trial group who have taken medications that can affect BPH symptoms within 3 months of postoperative follow-up.
9. Patients who have participated in other drug trials or medical device clinical trials within 3 months prior to enrollment.
10. Patients deemed unsuitable for participation in this clinical trial by the investigator.

Where it's running

• The First Affiliated Hospital of University of Science and Technology of China
  Hefei, Anhui, China Recruiting
• Fujian Provincial Hospital
  Fuzhou, Fujian, China Recruiting
• Quanzhou First Hospital
  Quanzhou, Fujian, China Recruiting
• Zhongshan Hospital Affiliated to Xiamen University
  Xiamen, Fujian, China Recruiting
• Zhangzhou Hospital of Fujian Province
  Zhangzhou, Fujian, China Recruiting
• Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University
  Shanghai, Shanghai Municipality, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sonablate HIFU Registry for Prostate Cancer and BPH

  This registry collects real-world data from men treated with Sonablate HIFU to see how well it works and how it affects urinary and sexual function over the long term.

  Recruiting Sonablate · Indianapolis, Indiana · NCT07757490

• Tamsulosin alone vs. tamsulosin with tadalafil for troublesome urinary symptoms from enlarged prostate

  This study tests whether adding tadalafil to tamsulosin helps men with BPH see better urinary symptoms and quality of life, using two tadalafil doses over 12 weeks.

  Recruiting Ain Shams University · Cairo, Cairo Governorate · NCT07722884

• MRI-DTI look at the urethral sphincter ring and prostate base shape

  This imaging study tests how the male urethral internal sphincter ring appears on MRI-DTI and how it relates to prostate base morphology in men undergoing clinically indicated MRI.

  Recruiting Jiangsu Taizhou People's Hospital · Taizhou, Jiangsu · NCT07694752

• Tamsulosin With or Without Tadalafil for a Trial Without Catheter After Acute Urinary Retention

  This study tests whether adding tadalafil to tamsulosin helps men with a first episode of acute urinary retention due to enlarged prostate pass urine without needing a catheter.

  Recruiting Phase 4 Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07654413

• Tamsulosin dose change or switch to silodosin before catheter removal in men with BPH-related acute urinary retention

  This trial tests whether continuing tamsulosin, increasing its dose, or switching to silodosin helps men with BPH-related acute urinary retention go without a catheter after seven days.

  Recruiting Phase 4 Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07650968

• Water Vapor Therapy vs Ejaculation-Sparing Enucleation for Benign Prostatic Hyperplasia

  This study tests whether Water Vapor Thermal Therapy (Rezum) or an ejaculation-sparing enucleation procedure better helps sexually active men with bothersome BPH symptoms.

  Recruiting Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07648888

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.