Benign Prostatic HyperplasiaNCT06263049
Is Ejaculation Preservation TURis the Natural Evolution of the "Gold Standard".
A study testing transurethral resection of prostate in people with Benign Prostatic Hyperplasia, run by Ain Shams University at 1 site in Egypt.
Trial summary
evaluation of the impact of apical urethral mucosa sparring with the urethra around the verumontanum on the ejaculatory function and early postoperative urinary incontinence Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- transurethral resection of prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 Feb 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Our inclusion criteria were preidentified to those who complained of voiding lower urinary tract symptoms (LUTS) and scheduled for TURP with prostate size less than 100 gm. This included patients with refractory retention, recurrent gross hematuria of prostatic origin, non-compliance to medical treatment, recurrent infection, and patients with bladder calculi secondary to obstruction. Exclusion criteria were: patients with neurogenic bladder, detrusor hypo-contractility, Diabetes more than 10 years, urethral stricture, or previous prostatic surgeries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ejaculatory Preserving Transurethral Resection of the Prostate.
evaluation of the impact of apical urethral mucosa sparring with the urethra around the verumontanum on the ejaculatory function and early postoperative urinary incontinence
Read the detailed description
Benign Prostatic Hyperplasia (BPH) is a common disease in elderly men and transurethral resection of the prostate (TURP) is still the gold standard for the treatment of BPH However, postoperative urinary incontinence (UI) and retrograde ejaculation are of the common complications and its incidence is nearly 2% of UI UI brings great suffering to patients and its unpredictability and uncertainty in the recovery period cause significant pressure to surgeons. External urethral sphincter damage is the main reason for UI after prostatectomy. The treatment of postoperative UI and post operative retrograde ejaculation has also become an important issue for many years. Along with the progress of technology, there have been various methods of transurethral resection of the prostate but no method has been found to adequately avoid the occurrence of UI and retrograde ejaculation
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- transurethral resection of prostate
- Keywords
- ejaculation, incontinence
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transurethral resection of prostateProcedure or surgery
resection of prostate by using bipolar cautarization
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | (TURP group underwent traditional TURP) Receives: Procedure: transurethral resection of prostate |
| group B | Active comparator | TURP with preserved urethral mucosa at the prostatic apex Receives: Procedure: transurethral resection of prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative antegrade ejaculation
the ability of the person to ejaculate post TURP procedure
Measured: within 1 month post operative
Secondary outcomes (1)
post operative urine continence
early postoperative urine continence
Measured: within 1 month post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 May 2023
- Primary completion1 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mohamed essmat aboughareb, consultant, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263049
- Sponsor's protocol ID
- ejaculation post TURP
- Status last verified
- Jan 2024
- First submitted
- 7 Feb 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liang JQ, Ma WT, Lu BW, Dai L, Zhao YM, Zhang JD, Tian B, Liu QL. Clinical Study on the Application of Preserved Urethral Mucosa at the Prostatic Apex in Transurethral Plasmakinetic Resection of the Prostate. Front Surg. 2022 Jun 17;9:922479. doi: 10.3389/fsurg.2022.922479. eCollection 2022.
PubMed 35784938
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ejaculatory Preserving Transurethral Resection of the Prostate.
- ClinicalTrials.gov ID
- NCT06263049
- Acronym / sponsor ID
- ejaculation post TURP
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- ejaculation, incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 16 Feb 2024 (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.
evaluation of the impact of apical urethral mucosa sparring with the urethra around the verumontanum on the ejaculatory function and early postoperative urinary incontinence
Detailed description
Benign Prostatic Hyperplasia (BPH) is a common disease in elderly men and transurethral resection of the prostate (TURP) is still the gold standard for the treatment of BPH However, postoperative urinary incontinence (UI) and retrograde ejaculation are of the common complications and its incidence is nearly 2% of UI UI brings great suffering to patients and its unpredictability and uncertainty in the recovery period cause significant pressure to surgeons. External urethral sphincter damage is the main reason for UI after prostatectomy. The treatment of postoperative UI and post operative retrograde ejaculation has also become an important issue for many years. Along with the progress of technology, there have been various methods of transurethral resection of the prostate but no method has been found to adequately avoid the occurrence of UI and retrograde ejaculation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: transurethral resection of prostate(TURP group underwent traditional TURP) |
| group B | Active comparator | Procedure: transurethral resection of prostateTURP with preserved urethral mucosa at the prostatic apex |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| transurethral resection of prostateresection of prostate by using bipolar cautarization | Procedure or surgery | group A, group B |
Primary outcome
post operative antegrade ejaculation
Time frame: within 1 month post operative
the ability of the person to ejaculate post TURP procedure
1 secondary outcome
post operative urine continence
Time frame: within 1 month post operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Results publication: PubMed 35784938Liang JQ, Ma WT, Lu BW, Dai L, Zhao YM, Zhang JD, Tian B, Liu QL. Clinical Study on the Application of Preserved Urethral Mucosa at the Prostatic Apex in Transurethral Plasmakinetic Resection of the Prostate. Front Surg. 2022 Jun 17;9:922479. doi: 10.3389/fsurg.2022.922479. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
mohamed essmat aboughareb, consultant study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transurethral resection of prostate in people with Benign Prostatic Hyperplasia, run by Ain Shams 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?
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: finished, as of the sponsor's last update on 24 Apr 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative antegrade ejaculation (time frame: within 1 month post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06263049, which also lists 1 linked publication.
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 24 Apr 2024.