Benign Prostatic Hyperplasia, Benign Prostatic Obstruction, Lower Urinary Tract Symptoms
Conditions
Keywords
Bipolar transurethral enucleation of the prostate, B-TUEP, Ejaculation preservation, International Prostate Symptom Score
Brief summary
This prospective randomized controlled trial will compare ejaculation-preserving bipolar transurethral enucleation of the prostate with standard bipolar transurethral enucleation of the prostate in sexually active men with benign prostatic hyperplasia and lower urinary tract symptoms after failed medical treatment. Participants will be randomly assigned to either ejaculation-preserving B-TUEP or standard B-TUEP. The study will evaluate preservation of ejaculatory function, erectile function, urinary symptom improvement, uroflowmetry outcomes, post-void residual urine, perioperative complications, and need for retreatment during follow-up.
Detailed description
Benign prostatic hyperplasia is a common cause of lower urinary tract symptoms in aging men. Surgical treatment is indicated when medical therapy fails or when symptoms remain bothersome. Bipolar transurethral enucleation of the prostate is an established endoscopic surgical technique for benign prostatic obstruction, but standard endoscopic prostate surgery may be associated with loss of antegrade ejaculation. This study will evaluate whether an ejaculation-preserving modification of bipolar transurethral enucleation of the prostate can preserve ejaculatory function while maintaining effective relief of lower urinary tract symptoms. The ejaculation-preserving technique will preserve the paracollicular tissue, the area approximately 1 cm proximal to the verumontanum, and bladder neck fibers, while avoiding deep enucleation behind the verumontanum. The control group will undergo standard bipolar transurethral enucleation of the prostate. Eligible sexually active men with benign prostatic hyperplasia and lower urinary tract symptoms after failed medical treatment will be randomized in a 1:1 ratio to ejaculation-preserving B-TUEP or standard B-TUEP. Sexual and urinary outcomes will be assessed using validated questionnaires and objective urinary parameters. Follow-up assessments will include ejaculatory function, erectile function, International Prostate Symptom Score, post-void residual urine, uroflowmetry, perioperative complications, and need for retreatment.
Interventions
PROCEDUREEjaculation-Preserving Bipolar Transurethral Enucleation of the Prostate
Ejaculation-preserving bipolar transurethral enucleation of the prostate will be performed with preservation of the paracollicular tissue, the area approximately 1 cm proximal to the verumontanum, and bladder neck fibers, while avoiding deep enucleation behind the verumontanum.
PROCEDUREStandard Bipolar Transurethral Enucleation of the Prostate
Standard bipolar transurethral enucleation of the prostate will be performed according to the conventional surgical technique without preservation of the paracollicular tissue and the area approximately 1 cm proximal to the verumontanum.
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The operating surgeon cannot be blinded because the surgical technique differs between groups. Participants and postoperative outcome assessors will be blinded to treatment allocation whenever feasible.
Intervention model description
Participants will be randomized in a 1:1 ratio to either ejaculation-preserving bipolar transurethral enucleation of the prostate or standard bipolar transurethral enucleation of the prostate.
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male patients with lower urinary tract symptoms secondary to benign prostatic obstruction after failed medical treatment for at least 3 months. * Sexually active patients with a continuous relationship with the same partner. * International Prostate Symptom Score of 8 or greater. * Transrectal ultrasound-estimated prostate size between 40 and 100 cc. * Eligible for bipolar transurethral enucleation of the prostate. * Ability to complete the required sexual and urinary function questionnaires. * Ability to provide written informed consent.
Exclusion criteria
* Preoperative sexual dysfunction. * Preoperative ejaculatory dysfunction. * Diagnosis or suspicion of prostate cancer. * Neurological disorders affecting lower urinary tract or sexual function. * Detrusor hypocontractility. * Catheter-dependent patients. * Patients with bladder stones. * Inability or refusal to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form Function Score From Baseline to 6 Months | Baseline and 6 months postoperatively | Ejaculatory function will be assessed using the Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form function score. The function score is based on three ejaculatory function items assessing ejaculation frequency, ejaculation force, and ejaculation volume. The total function score ranges from 1 to 15, with higher scores indicating better ejaculatory function. The outcome will be calculated as the 6-month postoperative score minus the baseline score. A smaller decrease or a positive change indicates better preservation of ejaculatory function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form Bother Score at 6 Months | 6 months postoperatively | Ejaculatory bother will be assessed using the bother item of the Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form. The bother score ranges from 0 to 5, with higher scores indicating greater bother related to ejaculatory dysfunction. |
| Preservation of Antegrade Ejaculation at 6 Months | 6 months postoperatively | The proportion of participants with preserved antegrade ejaculation at 6 months after surgery will be compared between the ejaculation-preserving B-TUEP group and the standard B-TUEP group. Preserved antegrade ejaculation will be defined as patient-reported antegrade seminal emission during orgasm after resumption of sexual activity. Participants reporting absent ejaculation, dry ejaculation, or retrograde ejaculation will be considered not to have preserved antegrade ejaculation. |
| Change in International Index of Erectile Function-5 Score From Baseline to 6 Months | Baseline and 6 months postoperatively | Erectile function will be assessed using the International Index of Erectile Function-5 questionnaire. The total score ranges from 5 to 25, with higher scores indicating better erectile function. The outcome will be calculated as the 6-month postoperative score minus the baseline score. |
| Change in International Prostate Symptom Score From Baseline to 6 Months | Baseline and 6 months postoperatively | Lower urinary tract symptoms will be assessed using the International Prostate Symptom Score. The total score ranges from 0 to 35, with higher scores indicating more severe urinary symptoms. The outcome will be calculated as the 6-month postoperative score minus the baseline score. |
| Change in Maximum Urinary Flow Rate From Baseline to 6 Months | Baseline and 6 months postoperatively | Maximum urinary flow rate will be measured by uroflowmetry and reported in milliliters per second. The outcome will be calculated as the 6-month postoperative maximum urinary flow rate minus the baseline maximum urinary flow rate. |
Countries
Egypt
Contacts
CONTACTHany F Badawy, MD
PRINCIPAL_INVESTIGATORHany F Badawy, MD
Faculty of medicine Beni-Suef University
Outcome results
None listed