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

Not Applicable

• Conditions: Prostate Hyperplasia; Transurethral Incision Of The Prostate; Ejaculatory Dysfunction
• Interventions: Procedure: Ejaculatory sparing TUIP; Procedure: Conventional TUIP

• Registration Number: NCT03176017
• Lead Sponsor: Mansoura University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-29
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-05
• Status Verified: 2020-09
• Study Start: 2020-10-01
• Last Update Submitted: 2020-12-05
• Last Update Posted: 2020-12-08
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ejaculatory sparing TUIP	Ejaculatory sparing TUIP	Ejaculatory sparing TUIP
Conventional TUIP	Conventional TUIP	regular non ejaculatory sparing TUIP

Primary Outcome Measures

Name	Time	Method
impact on ejaculatory function and subsequently the impact of reported ejaculatory changes on orgasm perception	1 year	Ejaculatory domain of Male sexual health questionnaire (Ej-MSHQ)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, Aldakahlia, Egypt