Ejaculatory Sparing Transurethral Incision Of The Prostate (ES-TUIP) Versus Conventional TUIP

Study Overview
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Brief Summary
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In this study, Investigators planned to compare ejaculatory sparing and non-ejaculatory sparing (conventional) TUIP using both subjective and objective assessment tools for the degree of deobstruction. Furthermore, the impact of both techniques on ejaculation and its secondary effect on orgasm perception and different domains of sexual function will be thoroughly assessed.

Official Title
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Ejaculatory Sparing Transurethral Incision Of The Prostate (ES-TUIP) Versus Conventional TUIP

Conditions
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Prostate Hyperplasia, Transurethral Incision Of The Prostate, Ejaculatory Dysfunction

Intervention / Treatment
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* Procedure: Ejaculatory sparing TUIP
* Procedure: Conventional TUIP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American society of anesthesiologists (ASA) score ≤3. TRUS estimated prostate weight ≤ 35 grams. Sexually interested and having continuous relationship with the same partner (interested). Bladder outlet obstruction index (BOOI ) ≥ 20 as per pressure flow study Exclusion Criteria: Preoperative sexual or ejaculatory disturbances or pelvic pain syndrome Neurological disorders that can affect potency and ejaculation e.g. long standing uncontrolled diabetes mellitus (DM) type 2 (> 10 years), DM type 1, cerebral stroke, Parkinsonism Urodynamic changes consistent with urethropathy or detrusor hypocontractility Previous pelvic surgeries or radiotherapy

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ejaculatory sparing TUIP<br>Ejaculatory sparing TUIP | Procedure: Ejaculatory sparing TUIP<br>* The bladder neck will be incised and vaporized at the 5 or 7-o'clock position. The incision will start near the ureteral orifice and carry downward to about 0.5-1.0 cm proximal to the verumontanum<br>* Other names: ES-TUIP;|
| Placebo Comparator: Conventional TUIP<br>regular non ejaculatory sparing TUIP | Procedure: Conventional TUIP<br>* the bladder neck will be incised by Collins knife at the 5 or 7-o'clock position till the verumontanum.<br>* Other names: regular non ejaculatory sparing TUIP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact on ejaculatory function and subsequently the impact of reported ejaculatory changes on orgasm perception | Ejaculatory domain of Male sexual health questionnaire (Ej-MSHQ) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile function domains (erectile function, orgasm, desire, intercourse satisfaction and overall satisfaction) | International index of erectile function-15 (IIEF-15) questionnaire | 1 year | 
| Patient reported functional urinary outcomes | International prostate symptom score (IPSS) questionnaire | 1 year | 
| maximum flow rate (Q.max) | milliliters per second. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ejaculatory Sparing, Transurethral Incision Of The Prostate, Prostate