NCT07327424

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Jul 2025Jun 2027

Study Start

First participant enrolled

July 15, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

December 25, 2025

Last Update Submit

December 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • International Prostate Symptom Score

    6 months

Secondary Outcomes (2)

  • Q max

    6 months

  • PVR (post-void residual volume)

    6 MONTHS

Study Arms (1)

Suprapubic Transvesical endoscopic prostatectomy

EXPERIMENTAL
Other: Suprapubic transvesical endoscopic prostatectomy

Interventions

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.

Suprapubic Transvesical endoscopic prostatectomy

Eligibility Criteria

Age55 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-Suef university

Banī Suwayf, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ahmed Abdelbary

Study Record Dates

First Submitted

December 25, 2025

First Posted

January 8, 2026

Study Start

July 15, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

January 8, 2026

Record last verified: 2025-12

Locations