Is Ejaculation Preservation TURis the Natural Evolution of the "Gold Standard".

April 20, 2024 updated by: Ain Shams University

Ejaculatory Preserving Transurethral Resection of the Prostate.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Benign Prostatic Hyperplasia (BPH) is a common disease in elderly men and transurethral resection of the prostate (TURP) is still the gold standard for the treatment of BPH However, postoperative urinary incontinence (UI) and retrograde ejaculation are of the common complications and its incidence is nearly 2% of UI UI brings great suffering to patients and its unpredictability and uncertainty in the recovery period cause significant pressure to surgeons. External urethral sphincter damage is the main reason for UI after prostatectomy. The treatment of postoperative UI and post operative retrograde ejaculation has also become an important issue for many years. Along with the progress of technology, there have been various methods of transurethral resection of the prostate but no method has been found to adequately avoid the occurrence of UI and retrograde ejaculation

Study Type

Interventional

Enrollment (Actual)

106

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
      • Cairo, Egypt
        • Ain shams 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

Yes

Description

Our inclusion criteria were preidentified to those who complained of voiding lower urinary tract symptoms (LUTS) and scheduled for TURP with prostate size less than 100 gm. This included patients with refractory retention, recurrent gross hematuria of prostatic origin, non-compliance to medical treatment, recurrent infection, and patients with bladder calculi secondary to obstruction. Exclusion criteria were: patients with neurogenic bladder, detrusor hypo-contractility, Diabetes more than 10 years, urethral stricture, or previous prostatic surgeries.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A
(TURP group underwent traditional TURP)
Procedure: transurethral resection of prostate
resection of prostate by using bipolar cautarization
Active Comparator: group B
TURP with preserved urethral mucosa at the prostatic apex
Procedure: transurethral resection of prostate
resection of prostate by using bipolar cautarization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative antegrade ejaculation
Time Frame: within 1 month post operative
the ability of the person to ejaculate post TURP procedure
within 1 month post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative urine continence
Time Frame: within 1 month post operative
early postoperative urine continence
within 1 month post operative

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Director: mohamed essmat aboughareb, consultant, Ain shams university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2023

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

February 7, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 20, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ejaculation post TURP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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