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

M

Mansoura University

Status

Unknown

Conditions

Ejaculatory Dysfunction
Prostate Hyperplasia
Transurethral Incision Of The Prostate

Treatments

Procedure: Ejaculatory sparing TUIP
Procedure: Conventional TUIP

Study type

Interventional

Funder types

Other

Identifiers

NCT03176017
HoLES-TUIP

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups, including a placebo group

Ejaculatory sparing TUIP
Active Comparator group
Description:
Ejaculatory sparing TUIP
Treatment:
Procedure: Ejaculatory sparing TUIP
Conventional TUIP
Placebo Comparator group
Description:
regular non ejaculatory sparing TUIP
Treatment:
Procedure: Conventional TUIP

Trial contacts and locations

1

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Central trial contact

Abdelwahab R. Hashem, Msc; Ahmed Alhussein, MBBCH

Data sourced from clinicaltrials.gov

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