Comparison of TUSP Versus TURP for Treatment of Benign Prostatic Hyperplasia in a Small Prostate Volume

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04912349
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

Comparison of transurethral split of the prostate versus transurethral resection of the prostate for treatment of benign prostatic hyperplasia in a small prostate volume: A prospective controlled study

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	Procedure: TUSP; Procedure: TURP	N/A

Detailed Description

Transurethral resection of the prostate (TURP) was considered as the golden standard to treat benign prostatic hyperplasia (BPH) for decades. However, TURP was associated with low efficiency to alleviate the lower urinary tract symptoms and a significantly higher risk of bladder neck contracture (BNC) for patients with small-volume BPH. We aimed to compare the therapeutic effect of transurethral split of the prostate (TUSP) with TURP for patients with small-volume BPH (<30 ml).

In this study, some selected small-volume BPH patients were randomly divided into two groups (TUSP and TURP group). The patient's baseline characteristics and perioperative outcomes were recorded. The follow-up was made at 6 months, 1 year and 2 years after surgical treatment.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Transurethral Split of the Prostate Versus Transurethral Resection of the Prostate for Treatment of Benign Prostatic Hyperplasia in a Small Prostate Volume: A Prospective Controlled Study
• Actual Study Start Date: Jul 1, 2020
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Group Patients received the transurethral split of the prostate(TUSP) treatment.	Procedure: TUSP; Patients received the transurethral split of the prostate(TUSP) treatment.
Active Comparator: Control Group Patients received the transurethral resection of the prostate(TURP) treatment.	Procedure: TURP; Patients received the transurethral resection of the prostate(TURP) treatment.

Outcome Measures

Primary Outcome Measures

1. international prostate symptoms score（IPSS） [within 24 months after surgery]

   Measuring the International Prostate Symptoms Score by a questionnaire (which minimum value is zero and the maximum value is 35; higher scores mean a worse outcome)

2. maximum urinary flow rate（Qmax） [within 24 months after surgery]

   Measuring the maximum urinary flow rate by a urodynamic study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Benign prostatic hyperplasia patients with surgical indication

• Maximum flow rate <12ml/s

• Prostate volume <30ml

• The international prostate symptoms score>21

• Medication of α-adrenergic blockers for at least 3 months

Exclusion Criteria:

• Acute prostatitis and urethritis

• Neurogenic bladder

• Abnormal prostate-specific antigen level

• Urethral injury history

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310009

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

• Principal Investigator: Jiaming Wen, Dr., Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04912349
• Other Study ID Numbers: 2020-525
• First Posted: Jun 3, 2021
• Last Update Posted: Jun 3, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia

Study Results

No Results Posted as of Jun 3, 2021