Back to resultsEjaculatory Sparing Transurethral Incision Of The Prostate (ES-TUIP) Versus Conventional TUIP
Primary Purpose
Prostate Hyperplasia, Transurethral Incision Of The Prostate, Ejaculatory Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ejaculatory sparing TUIP
Conventional TUIP
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Hyperplasia focused on measuring Transurethral Incision Of The Prostate, Prostate, Ejaculatory Sparing
Eligibility Criteria
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
Sites / Locations
- Urology and Nephrology CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ejaculatory sparing TUIP
Conventional TUIP
Arm Description
Ejaculatory sparing TUIP
regular non ejaculatory sparing TUIP
Outcomes
Primary Outcome Measures
impact on ejaculatory function and subsequently the impact of reported ejaculatory changes on orgasm perception
Ejaculatory domain of Male sexual health questionnaire (Ej-MSHQ)
Secondary Outcome Measures
Erectile function domains (erectile function, orgasm, desire, intercourse satisfaction and overall satisfaction)
International index of erectile function-15 (IIEF-15) questionnaire
Patient reported functional urinary outcomes
International prostate symptom score (IPSS) questionnaire
maximum flow rate (Q.max)
milliliters per second.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03176017
Brief Title
Ejaculatory Sparing Transurethral Incision Of The Prostate (ES-TUIP) Versus Conventional TUIP
Official Title
Ejaculatory Sparing Transurethral Incision Of The Prostate (ES-TUIP) Versus Conventional TUIP
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Hyperplasia, Transurethral Incision Of The Prostate, Ejaculatory Dysfunction
Keywords
Transurethral Incision Of The Prostate, Prostate, Ejaculatory Sparing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ejaculatory sparing TUIP
Arm Type
Active Comparator
Arm Description
Ejaculatory sparing TUIP
Arm Title
Conventional TUIP
Arm Type
Placebo Comparator
Arm Description
regular non ejaculatory sparing TUIP
Intervention Type
Procedure
Intervention Name(s)
Ejaculatory sparing TUIP
Other Intervention Name(s)
ES-TUIP
Intervention Description
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
Intervention Name(s)
Conventional TUIP
Other Intervention Name(s)
regular non ejaculatory sparing TUIP
Intervention Description
the bladder neck will be incised by Collins knife at the 5 or 7-o'clock position till the verumontanum.
Primary Outcome Measure Information:
Title
impact on ejaculatory function and subsequently the impact of reported ejaculatory changes on orgasm perception
Description
Ejaculatory domain of Male sexual health questionnaire (Ej-MSHQ)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Erectile function domains (erectile function, orgasm, desire, intercourse satisfaction and overall satisfaction)
Description
International index of erectile function-15 (IIEF-15) questionnaire
Time Frame
1 year
Title
Patient reported functional urinary outcomes
Description
International prostate symptom score (IPSS) questionnaire
Time Frame
1 year
Title
maximum flow rate (Q.max)
Description
milliliters per second.
Time Frame
1 year
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelwahab R. Hashem, Msc
Phone
01069678979
Ext
002
Email
abdelwahab_hashem@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Alhussein, MBBCH
Phone
00201009074121
Email
ahmedalhussein20@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Shoma, MD
Organizational Affiliation
Urology and Nephrology center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nasr Eltabey, MD
Organizational Affiliation
Urology and Nephrology center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed N Elshal, MD
Organizational Affiliation
Urology and Nephrology center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mahmoud Laimon, Msc
Organizational Affiliation
Urology and Nephrology center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed Elkashef
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansoura
State/Province
Aldakahlia
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelwahab R. Hashem, Msc
Phone
00201069678979
Email
abdelwahab_hashem@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ahmed M Elshal, MD
Phone
+20502202222
Ext
1643
Email
elshalam@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Yes meta-analyses by contact the Dr Ahmed Elshal, MD (Study Chair)
Learn more about this trial
Ejaculatory Sparing Transurethral Incision Of The Prostate (ES-TUIP) Versus Conventional TUIP
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