NCT03176017

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
3.3 years until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

December 8, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

May 29, 2017

Last Update Submit

December 5, 2020

Conditions

Prostate HyperplasiaTransurethral Incision Of The ProstateEjaculatory Dysfunction

Keywords

Transurethral Incision Of The ProstateProstateEjaculatory Sparing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Erectile function domains (erectile function, orgasm, desire, intercourse satisfaction and overall satisfaction)

    1 year

  • Patient reported functional urinary outcomes

    1 year

  • maximum flow rate (Q.max)

    1 year

Study Arms (2)

Ejaculatory sparing TUIP

ACTIVE COMPARATOR

Ejaculatory sparing TUIP

Procedure: Ejaculatory sparing TUIP

Conventional TUIP

PLACEBO COMPARATOR

regular non ejaculatory sparing TUIP

Procedure: Conventional TUIP

Interventions

Ejaculatory sparing TUIPPROCEDURE

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

Also known as: ES-TUIP
Ejaculatory sparing TUIP
Conventional TUIPPROCEDURE

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

Also known as: regular non ejaculatory sparing TUIP
Conventional TUIP

Eligibility Criteria

Age40 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Prostatic HyperplasiaEjaculatory Dysfunction

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesSexual Dysfunction, Physiological

Study Officials

  • Ahmed M Shoma, MD

    Urology and Nephrology center

    STUDY CHAIR

  • Nasr Eltabey, MD

    Urology and Nephrology center

    STUDY DIRECTOR

  • Ahmed N Elshal, MD

    Urology and Nephrology center

    STUDY DIRECTOR

  • Mahmoud Laimon, Msc

    Urology and Nephrology center

    PRINCIPAL INVESTIGATOR

  • Ahmed Elkashef

    Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdelwahab R. Hashem, Msc

CONTACT

01069678979abdelwahab_hashem@yahoo.com

Ahmed Alhussein, MBBCH

CONTACT

00201009074121ahmedalhussein20@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 5, 2017

Study Start

October 1, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

December 8, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Yes meta-analyses by contact the Dr Ahmed Elshal, MD (Study Chair)

Locations

EG(1)