Feasibility of Suprapubic Transvesical Endoscopic Prostatectomy

December 25, 2025 updated by: Ahmed M Abdelbary, MD, Beni-Suef University
In patients with penile prosthesis, any transurethral procedure could place the implant at risk. The use of long or extra-long resectoscope can be of some assistance; however, these are not available in many institutions. So suprapubic transvesical endoscopic prostatectomy is newly developed to bypass the anterior urethra. Thus, the aim of this study is to determine safety and efficacy of Suprapubic Transvesical endoscopic prostatectomy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Banī Suwayf, Egypt
        • Beni-Suef University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male patients with moderate to severe lower urinary tract symptoms ( IPSS score ≥ 8 ) indicated for surgical intervention with prostate size less than 120 cc.

Exclusion Criteria:

  • History of previous pelvic surgery, urothelial cancer, kidney transplantation, uncontrolled coagulopathy, and significant central fat accumulation that could potentially increase the risk during transvesical access(body mass index not exceeding 27 kg/m2)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suprapubic Transvesical endoscopic prostatectomy
Other: Suprapubic transvesical endoscopic prostatectomy
Cysto-uretheroscopy will be done to evaluate the urethera , detect any bladder pathology and to visualise steps of insertion of laparoscopic port. The patient will be in supine position, and the surgeon will stand beside the patient .The bladder is filled with normal saline until it is completely full . Using Ultrasound A 18 G puncture needle is inserted 4 cm above the upper margin of the symphysis pubis to gain access to the bladder. then track is formed through single step dilation using a 30 Fr amplatz dilator and 10 mm laparoscopic port over it. Before starting the procedure, the ureteral orifices must be identified.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
International Prostate Symptom Score
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Q max
Time Frame: 6 months
6 months
PVR (post-void residual volume)
Time Frame: 6 MONTHS
6 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 25, 2025

First Submitted That Met QC Criteria

December 25, 2025

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

December 25, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • FMBSUREC/01072025/Mohamed

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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