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

NCT ID: NCT03176017

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-10-01

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.

Detailed Description

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Conditions

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Prostate Hyperplasia Transurethral Incision Of The Prostate Ejaculatory Dysfunction

Keywords

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Transurethral Incision Of The Prostate Prostate Ejaculatory Sparing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ejaculatory sparing TUIP

Ejaculatory sparing TUIP

Group Type ACTIVE_COMPARATOR

Ejaculatory sparing TUIP

Intervention Type PROCEDURE

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

regular non ejaculatory sparing TUIP

Group Type PLACEBO_COMPARATOR

Conventional TUIP

Intervention Type PROCEDURE

the bladder neck will be incised by Collins knife at the 5 or 7-o'clock position till the verumontanum.

Interventions

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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

Intervention Type PROCEDURE

Conventional TUIP

the bladder neck will be incised by Collins knife at the 5 or 7-o'clock position till the verumontanum.

Intervention Type PROCEDURE

Other Intervention Names

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ES-TUIP regular non ejaculatory sparing TUIP

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
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Abdelwahab Hashem

Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed M Shoma, MD

Role: STUDY_CHAIR

Urology and Nephrology center

Nasr Eltabey, MD

Role: STUDY_DIRECTOR

Urology and Nephrology center

Ahmed N Elshal, MD

Role: STUDY_DIRECTOR

Urology and Nephrology center

Mahmoud Laimon, Msc

Role: PRINCIPAL_INVESTIGATOR

Urology and Nephrology center

Ahmed Elkashef

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Urology and Nephrology Center

Al Mansurah, Aldakahlia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Abdelwahab R. Hashem, Msc

Role: CONTACT

Phone: 01069678979

Email: [email protected]

Ahmed Alhussein, MBBCH

Role: CONTACT

Phone: 00201009074121

Email: [email protected]

Facility Contacts

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Abdelwahab R. Hashem, Msc

Role: primary

Ahmed M Elshal, MD

Role: backup

Other Identifiers

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HoLES-TUIP

Identifier Type: -

Identifier Source: org_study_id