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

December 5, 2020 updated by: Abdelwahab Hashem, Mansoura University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Aldakahlia
      • Mansoura, Aldakahlia, Egypt, 35516

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ejaculatory sparing TUIP
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
Other Names:
  • ES-TUIP
Placebo Comparator: Conventional TUIP
regular non ejaculatory sparing TUIP
Procedure: Conventional TUIP
the bladder neck will be incised by Collins knife at the 5 or 7-o'clock position till the verumontanum.
Other Names:
  • regular non ejaculatory sparing TUIP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
impact on ejaculatory function and subsequently the impact of reported ejaculatory changes on orgasm perception
Time Frame: 1 year
Ejaculatory domain of Male sexual health questionnaire (Ej-MSHQ)
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Chair: Ahmed M Shoma, MD, Urology and nephrology center
  • Study Director: Ahmed N Elshal, MD, Urology and nephrology center
  • Principal Investigator: Ahmed Elkashef, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

May 29, 2017

First Submitted That Met QC Criteria

June 2, 2017

First Posted (Actual)

June 5, 2017

Study Record Updates

Last Update Posted (Actual)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 5, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HoLES-TUIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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