NCT05914519

Brief Summary

The purpose of this study is to assess the outcomes and efficacy of ejaculatory preserving TURP in terms of voiding, erectile function, and ejaculation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
7 months until next milestone

Results Posted

Study results publicly available

January 6, 2026

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

June 12, 2023

Results QC Date

November 16, 2025

Last Update Submit

December 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Preservation of Ejaculation

    The number of patients who can ejaculate after TURP

    6 months

Secondary Outcomes (1)

  • Maximum Flow Rate (Qmax)

    6 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR
Procedure: Ejaculatory Preserving Transurethral resection of prostate

Group 2

ACTIVE COMPARATOR
Procedure: Standard Transurethral Resection of prostate

Interventions

Transurethral resection of prostate with preservation of 1cm safety area above verumontanum and without paracollicular digging

Also known as: EpTURP
Group 1

Transurethral resection of prostate including whole adenoma till the capsule.

Also known as: Standard TURP
Group 2

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient \> 45 years old.
  • Drug refractory urinary retention.
  • Prostate volume range: 20-60 mL.
  • IPSS \> 19 after the medical therapy failure.
  • Qmax \< 10 mL/s.
  • PSA \< 4 ng/mL.
  • Active and healthy sexual life.

You may not qualify if:

  • History of prostate or urethral surgery.
  • Neurogenic bladder.
  • UTI.
  • Urethral stricture disease.
  • prostate cancer.
  • Bleeding diathesis.
  • Capsular or bladder perforation during surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Sohag Governorate, Egypt

Location

MeSH Terms

Conditions

Ejaculatory Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital Diseases

Limitations and Caveats

* Single center study that may result in different findings than elsewhere. * Small sample size that may produce insignificant results. * Relatively short period of follow-up. * We didn't compare Ejaculatory preserving TURP with other established surgical or minimally invasive techniques such as aquablation and Holmium laser enucleation with ejaculatory sparing modifications.

Results Point of Contact

Title
Ahmed Sabri mahmoud
Organization
faculty of medicine sohag university

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 12, 2023

First Posted

June 22, 2023

Study Start

July 1, 2023

Primary Completion

January 1, 2025

Study Completion

June 1, 2025

Last Updated

January 6, 2026

Results First Posted

January 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations