Prostate HyperplasiaNCT03176017
Ejaculatory Sparing Transurethral Incision Of The Prostate (ES-TUIP) Versus Conventional TUIP
A study testing Ejaculatory sparing TUIP and Conventional TUIP in people with Prostate Hyperplasia and Transurethral Incision Of The Prostate, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Hyperplasia, Transurethral Incision Of The Prostate, Ejaculatory Dysfunction
- What is being tested?
- Ejaculatory sparing TUIP and Conventional TUIP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology and Nephrology Center
Al Mansurah, Aldakahlia, 35516
Abdelwahab R. Hashem, Msc, 00201069678979, abdelwahab_hashem@yahoo.com
Ahmed M Elshal, MD, +20502202222 ext. 1643, elshalam@hotmail.com
About this study
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.
- Being tested
- Ejaculatory sparing TUIP, Conventional TUIP
- Keywords
- Transurethral Incision Of The Prostate, Prostate, Ejaculatory Sparing
- Medical subject headings
- Prostatic Hyperplasia, Ejaculatory Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ejaculatory sparing TUIPProcedure or surgery
Also called ES-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
Conventional TUIPProcedure or surgery
Also called regular non ejaculatory sparing TUIP
the bladder neck will be incised by Collins knife at the 5 or 7-o'clock position till the verumontanum.
| Study group | Role | What they receive |
|---|---|---|
| Ejaculatory sparing TUIP | Active comparator | Ejaculatory sparing TUIP Receives: Procedure: Ejaculatory sparing TUIP |
| Conventional TUIP | Placebo comparator | regular non ejaculatory sparing TUIP Receives: Procedure: Conventional TUIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
impact on ejaculatory function and subsequently the impact of reported ejaculatory changes on orgasm perception
Ejaculatory domain of Male sexual health questionnaire (Ej-MSHQ)
Measured: 1 year
Secondary outcomes (3)
Erectile function domains (erectile function, orgasm, desire, intercourse satisfaction and overall satisfaction)
International index of erectile function-15 (IIEF-15) questionnaire
Measured: 1 year
Patient reported functional urinary outcomes
International prostate symptom score (IPSS) questionnaire
Measured: 1 year
maximum flow rate (Q.max)
milliliters per second.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Oct 2020
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate HyperplasiaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelwahab Hashem, Mansoura University
- Investigators
- Ahmed M Shoma, MD, Study chair, Urology and Nephrology centerNasr Eltabey, MD, Study director, Urology and Nephrology centerAhmed N Elshal, MD, Study director, Urology and Nephrology centerMahmoud Laimon, Msc, Principal investigator, Urology and Nephrology centerAhmed Elkashef, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176017
- Sponsor's protocol ID
- HoLES-TUIP
- Status last verified
- Sep 2020
- First submitted
- 29 May 2017
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes meta-analyses by contact the Dr Ahmed Elshal, MD (Study Chair)
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ejaculatory Sparing Transurethral Incision Of The Prostate (ES-TUIP) Versus Conventional TUIP
- ClinicalTrials.gov ID
- NCT03176017
- Acronym / sponsor ID
- HoLES-TUIP
- Keywords
- Transurethral Incision Of The Prostate, Prostate, Ejaculatory Sparing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ejaculatory sparing TUIP | Active comparator | Procedure: Ejaculatory sparing TUIPEjaculatory sparing TUIP |
| Conventional TUIP | Placebo comparator | Procedure: Conventional TUIPregular non ejaculatory sparing TUIP |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ejaculatory sparing TUIPAlso: ES-TUIPThe 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 | Procedure or surgery | Ejaculatory sparing TUIP |
| Conventional TUIPAlso: regular non ejaculatory sparing TUIPthe bladder neck will be incised by Collins knife at the 5 or 7-o'clock position till the verumontanum. | Procedure or surgery | Conventional TUIP |
Primary outcome
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)
3 secondary outcomes
Erectile function domains (erectile function, orgasm, desire, intercourse satisfaction and overall satisfaction)
Time frame: 1 year
Patient reported functional urinary outcomes
Time frame: 1 year
maximum flow rate (Q.max)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Individual participant dataSharing planned: Yes. Yes meta-analyses by contact the Dr Ahmed Elshal, MD (Study Chair)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M Shoma, MD study chair
Urology and Nephrology center
Nasr Eltabey, MD study director
Urology and Nephrology center
Ahmed N Elshal, MD study director
Urology and Nephrology center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ejaculatory sparing TUIP and Conventional TUIP in people with Prostate Hyperplasia and Transurethral Incision Of The Prostate, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelwahab R. Hashem, Msc (01069678979 ext. 002, abdelwahab_hashem@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impact on ejaculatory function and subsequently the impact of reported ejaculatory changes on orgasm perception (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.