NCT06263049

Brief Summary

evaluation of the impact of apical urethral mucosa sparring with the urethra around the verumontanum on the ejaculatory function and early postoperative urinary incontinence

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 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

Study Start

First participant enrolled

May 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
Last Updated

April 24, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

February 7, 2024

Last Update Submit

April 20, 2024

Conditions

Benign Prostatic Hyperplasia

Keywords

ejaculation, incontinence

Outcome Measures

Primary Outcomes (1)

  • post operative antegrade ejaculation

    the ability of the person to ejaculate post TURP procedure

    within 1 month post operative

Secondary Outcomes (1)

  • post operative urine continence

    within 1 month post operative

Study Arms (2)

group A

ACTIVE COMPARATOR

(TURP group underwent traditional TURP)

Procedure: transurethral resection of prostate

group B

ACTIVE COMPARATOR

TURP with preserved urethral mucosa at the prostatic apex

Procedure: transurethral resection of prostate

Interventions

transurethral resection of prostatePROCEDURE

resection of prostate by using bipolar cautarization

group Agroup B

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university

Cairo, Egypt

Location

Related Publications (1)

  • Liang JQ, Ma WT, Lu BW, Dai L, Zhao YM, Zhang JD, Tian B, Liu QL. Clinical Study on the Application of Preserved Urethral Mucosa at the Prostatic Apex in Transurethral Plasmakinetic Resection of the Prostate. Front Surg. 2022 Jun 17;9:922479. doi: 10.3389/fsurg.2022.922479. eCollection 2022.

    PMID: 35784938RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • mohamed essmat aboughareb, consultant

    Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 16, 2024

Study Start

May 1, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

April 24, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)