Outcomes and Efficacy of Ejaculatory Preserving Transurethral Resection of Prostate

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

Study Overview

• Status: Not yet recruiting
• Conditions: BPH; Ejaculatory Dysfunction
• Intervention / Treatment: Procedure: Ejaculatory Preserving Transurethral resection of prostate; Procedure: Standard Transurethral Resection of prostate

Detailed Description

The prostatic gland plays a central role in andrology. It is involved both in fertility and in sexuality with a major role in ejaculation and possibly in orgasm. This could explain the association between the andrological symptoms and prostatic disorders.

The prevalence of Benign Prostatic Hyperplasia (BPH) is approximately 50% for men in their fifties and reaches up to 80% for men over 80 years of age, representing one of the most common diseases affecting males, with potentially significant impact on their quality of life.

It is estimated that around half of men suffering severe or medical treatment unresponsive lower urinary tract symptoms (LUTS) will be offered a surgical procedure to relieve benign prostatic obstruction (BPO).

Despite continuing development of new minimally invasive surgical methods, transurethral resection of the prostate (TURP) still remains the gold standard surgical treatment for LUTS due to BPH.

Although it is benign, this disease has been shown to have a negative impact on the patient's health-related quality of life (HRQL), marked by obstructive and irritative LUTS.

As BPH in most cases is not a life-threatening condition, the main outcomes of its treatment are not only the improvement in LUTS and functional parameters but also quality of life after surgery.

Whilst efficacy of the conventional TURP is proven, a common potentially bothersome side effect, the retrograde ejaculation (RE) which occurs in 65-90% of patients undergoing TURP.

It has been reported that ablative techniques like TURP and recent laser procedures including holmium, thulium and greenlight cause similar rates of ejaculatory dysfunction, occurring in almost three out of four to five men.

For decades, men have been counseled to expect dry orgasm after TURP because of the retrograde flow of semen as a result of bladder neck disruption.

Erectile dysfunction and Ejaculatory dysfunction (EjD) can have a substantial deleterious effect on the Quality of life (QoL) of men who have previously maintained regular sexual activity, inducing significantly increased levels of anxiety and depression.

More recently, a better understanding of ejaculation physiology has enabled the emergence of modified surgical techniques with the aim of preserving antegrade ejaculation.

The key point of standard TURP is resecting the tissues enveloped in the prostatic capsule and the bladder neck, while protecting the urethral tissues below the verumontanum.

The bladder neck plays a significant role in reproduction. For men, bladder neck closure facilitates anterograde ejaculation. It actively contracts the bladder neck during ejaculation through a rich noradrenergic innervation by sympathetic nerves.

Vernet et al. showed that contraction of the bladder neck was not important for anterograde ejaculation. Using endorectal ultrasound videos performed during masturbation in 30 men, it was possible to visualize the bladder neck, the prostate, and the bulbar urethra during ejaculation. They observed that during ejaculation, the verumontanum underwent a slight caudal shift, momentarily making contact with the opposite urethral wall and sperm emitted from the ejaculatory ducts was directed distally by contractions of the external sphincter coordinated with contractions of the bulbar urethra, thus demonstrating the importance of the muscular tissue around the verumontanum and particularly its proximal part. They described this area as a "high-pressure ejaculatory area". The closure of the bladder neck did not seem to play a role in this mechanism. As a result, one can conclude that as long as the tissues around the verumontanum are not injured, ejaculation should still occur even with a well-open bladder neck.

Recently, together with a better understanding of the mechanisms of ejaculation, a greater importance has been given to the impact of dry ejaculation on patients' QoL. A balance between symptomatic improvement in LUTS and preservation of sexual function needs to be addressed for men seeking surgical treatment.

Modifications based on Supramontanal sparing hypothesis have reported favorable outcomes to as high as 92%.

Although preservation of bladder neck structures is often associated with preservation of antegrade ejaculation, the current modern approach is the preservation of the precollicular and para-collicular tissue in the area where the ejaculatory ducts emerge near the verumontanum in the distal apical tissue in laser, aquablation, and bipolar electrosurgical prostatectomy techniques.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1	Procedure: Ejaculatory Preserving Transurethral resection of prostate; Transurethral resection of prostate with preservation of 1cm safety area above verumontanum and without paracollicular digging; Other Names: EpTURP
Active Comparator: Group 2	Procedure: Standard Transurethral Resection of prostate; Transurethral resection of prostate including whole adenoma till the capsule.; Other Names: Standard TURP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Prostate Symptom Score	IPSS assess voiding which has a range from 0 to 35. Increase in score means worsening of symptoms	6 months
Uro-flow-metry (Qmax)	Qmax assess voiding. Decrease in Qmax means worsening of voiding. Unit of Qmax is ml/sec	6 months
Male Sexual Health Questionnaire - Ejaculatory Dysfunction short form (MSHQ-EjD)	MSHQ-EjD assess ejaculation. It consist of 2 items, the first is ejaculatory function which ranges from 1 to 15 and increase in score means improving of ejaculation. The second is satisfaction score which ranges from 0 to 5 and increase in score means worsening of ejaculation.	6 monthes
International Index of erectile function	IIEF score assess erection. It ranges from 5 to 25. Increase in score means improving of erectile function.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication	Rate of complications will be assessed	6 months

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Soh-Med-23-06-02MD

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