- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07513896
Factors Predicting The Success of Ejaculation Sparing Transurethral Resection of Prostate in Benign Prostatic Hyperplasia Patients
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt, 11566
- AinShams University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- sexually active male patient with normal ejaculatory function
- upper urinary tract affection and renal insufficiency.
- Chronic Urinary Retention
- Patients with failed medical therapy.
- Patients not compliant to medical treatment
- Patients with recurrent hematuria or recurrent lower urinary tract infections
Exclusion Criteria:
- Patients with an anterior urethral stricture
- Patients with history of urethral operations
- Patients with previous prostatic surgery
- Patients with neurological disorders
- Non sexually active patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: patients with BPH underwent Ejaculatory preserving TURP
|
In our study, we performed an EP-TURP technique, which is adopted in our institute and involves the preservation of 1 cm of urethral mucosa all around the verumontanum, including the prostatic apical urethral mucosa, with adequate resection of the prostatic adenoma, including the apical prostatic tissue, which was resected lateral to the spared urethral mucosa to ensure adequate management of the outflow obstruction. (8). Bi-polar TURP was performed using a 26 Fr. Resectoscope (Karl Storz, Tuttlingen, Germany) and Karl Storz- AUTOCON® IV. Intraoperative cystoscopic evaluation and documentation of the prostatic anatomy were done. SML was measured cystoscopically using a 22 Fr sheath with centimeter markings. Operative time, perioperative complications, catheterization duration, and hospital stay were recorded. Urethral catheter removal was planned after 24-48 hours unless prolonged catheterization was clinically indicated. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preservation of antegrade ejaculation at 3 months
Time Frame: 3 months
|
The primary outcome was to assess the post operative ejaculation at 3 months using Male Sexual Health Questionnaire for ejaculatory dysfunction short form (MSHQ-Ej.D-SF).
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
post-operative post-voiding residual volume
Time Frame: 3 months
|
Measurement of post-operative post-voiding residual volume by Pelvi-abdominal Ultrasound
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
post operative complication
Time Frame: 3 months
|
assess post operative complications using Clavien-Dindo classification for TURP
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 2. Tawfik AM, Alloussi S, Ben Rhouma S. (2017). Ejaculation-Sparing Techniques in TURP for Benign Prostatic Hyperplasia: A Systematic Review and Meta-analysis. Journal of Urology; 197(4): 1050-1057.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU MS 397/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Benign Prostatic Hyperplasia
-
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-
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-
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Boston Scientific CorporationCompletedProstatic Hyperplasia | Benign Prostatic Hyperplasia | Prostatic Hyperplasia, Benign | Prostatic Hypertrophy | Prostatic Hypertrophy, Benign | Adenoma, Prostatic | Prostatic Adenoma | RezumDominican Republic, Czechia, Sweden
-
Boston Scientific CorporationCompletedBenign Prostatic Hyperplasia | Prostatic Hyperplasia, Benign | Prostatic Hypertrophy | Prostatic Hypertrophy, Benign | Adenoma, Prostatic | Prostatic Adenoma | RezumDominican Republic
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-
IMBiotechnologies Ltd.CompletedBenign Prostatic Hyperplasia | Benign Prostatic HypertrophyCanada
-
Astellas Pharma Korea, Inc.Not yet recruiting
Clinical Trials on ejaculatory preserving TURP
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-
Ain Shams UniversityRecruiting
-
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-
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-
Lille Catholic UniversityTerminatedSpinal Cord Diseases | Disorder of EjaculationFrance
-
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-
Mansoura UniversityUnknownProstate Hyperplasia | Transurethral Incision Of The Prostate | Ejaculatory DysfunctionEgypt
-
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-
Assiut UniversityNot yet recruitingPSA Changes After TURP
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