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NCT03176017 Clinical Trial

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

Prostate Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03176017
Other study ID # HoLES-TUIP
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date October 1, 2021

Study information
Verified date September 2020
Source Mansoura University
Contact Abdelwahab R. Hashem, Msc
Phone 01069678979
Email abdelwahab_hashem@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date October 1, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender Male
Age group 40 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Ejaculatory sparing TUIP
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
• Conventional TUIP
the bladder neck will be incised by Collins knife at the 5 or 7-o'clock position till the verumontanum.

Locations
Country Name City State
Egypt Urology and Nephrology Center Mansoura Aldakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

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