Post Prostatectomy IncontinenceMansprostIVNCT03494049
Veil Preserving HoLEP vs. Stanadard HoLEP
A study testing Veil sparring HoLEP and Standard HoLEP in people with Post Prostatectomy Incontinence, run by Mansoura University at 1 site in Egypt.
Trial summary
Postoperative transient stress urine leakage following Holmium laser enucleation of the prostate is one of the problems that frustrate both surgeon and patients Standard HoLEP might be associated with some stretch of the sphincter and de-epithelization of the sphincter area anteriorly. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Post Prostatectomy Incontinence
- What is being tested?
- Veil sparring HoLEP and Standard HoLEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Apr 2016to 12 Dec 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients' age ≥50 years
- ASA (American society of anesthesiologists) score ≤3.
- TRUS estimated weight ≥40 grams.
Who cannot join
- Patients who have any of the following were excluded:
- Patient with neurological disorder which might affect bladder function as cerebrovascular stroke or Parkinson disease.
- Active urinary tract infection.
- Presence of bladder cancer (within the last 2 years).
- Prostate cancer patients.
- Patients with bleeding tendency, ongoing anticoagulants or antiplatelet medications
- Previous prostate surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Veil-preserving Versus Standard Holmium Laser Enucleation of the Prostate: Randomized Clinical Trial
Postoperative transient stress urine leakage following Holmium laser enucleation of the prostate is one of the problems that frustrate both surgeon and patients
Standard HoLEP might be associated with some stretch of the sphincter and de-epithelization of the sphincter area anteriorly.
In Veil preserving HoLEP, early separation of the adenoma from the sphincter ring minimizes sphincter stretch. Furthermore, more proximal incision of the 12 O'clock mucosal strip sparring a veil of mucosa covering the sphincter ring.
Our hypothesis is that by this technique the early postoperative transient urine leak would be minimized and duration of leakage if anny would be shortened.
Read the detailed description
Postoperative transient stress urine leakage following Holmium laser enucleation of the prostate is one of the problems that frustrate both surgeon and patients.
Many reports addressed different variables for the cause of post HoLEP urine leakage. Looking for a procedure done by a single surgeon who had tremendous experience of this procedure may enable investigators to identify precisely technical points of interest that may affect post HoLEP stress urine incontinence.
Standard HoLEP might be associated with some stretch of the sphincter and de-epithelization of the sphincter area anteriorly.
In Veil preserving HoLEP, early separation of the adenoma from the sphincter ring minimizes sphincter stretch. Furthermore, more proximal incision of the 12 O'clock mucosal strip sparring a veil of mucosa covering the sphincter ring.
Investigators' hypothesis is that by this technique the early postoperative transient urine leak would be minimized and duration of leakage if any would be shortened.
- Conditions
- Post Prostatectomy Incontinence
- Being tested
- Veil sparring HoLEP, Standard HoLEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veil sparring HoLEPProcedure or surgery
Also called early apical separation
Early mucosal incision; lateral to the Veru and proximal to the apical bulge of the adenoma, followed by early separation of the adenoma from the sphincter ring after identification of the plane of enucleation, this minimizes sphincter stretch.
Furthermore, more proximal incision of the 12 O'clock mucosal strip sparring a veil of mucosa covering the sphincter ring.
Standard HoLEPProcedure or surgery
Holmium laser enucleation of the prostate in the standard approach described by Elhilali et al 2010
| Study group | Role | What they receive |
|---|---|---|
| Veil sparring HoLEP | Active comparator | Early mucosal incision lateral to the Veru followed by early separation of the adenoma from the sphincter ring after identification of the plane of enucleation, this minimizes sphincter stretch.
Furthermore, more proximal incision of the 12 O'clock mucosal strip sparring a veil of mucosa covering the sphincter ring. Receives: Procedure: Veil sparring HoLEP |
| Standard HoLEP | Active comparator | Standard HoLEP TECHNIQUE as described by Elhilali et al 2010 Receives: Procedure: Standard HoLEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine incontinence
one hour pad test for post prostatectomy incontinence, scale from 0 to 4, the higher the more incontinence
Measured: 1 month postoperative
Secondary outcomes (4)
international prostate symptom score
Symptoms core assessment, score from 0 to 35, the higher the worse the urinary symptoms
Measured: 1 year
urine flow rate
rate of urine flow per unit time, how many milliliters of urine passed per second, above 15ml/second is normal
Measured: 1 year
urine incontinence
one hour pad test for post prostatectomy incontinence, scale from 0 to 4, the higher the more incontinence
Measured: 4 months postoperative
International Consultation on Incontinence Questionnaire Short-Form
Continence core assessment, score from 0 to 21, the higher the worse the urinary continence
Measured: one month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start22 Apr 2016
- Primary completion8 Dec 2020
- Study completion12 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Prostatectomy IncontinenceStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elshal, Mansoura University
- Investigators
- Ahmed Elshal, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494049
- Sponsor's protocol ID
- RP.19.11.49
- Acronym
- MansprostIV
- Status last verified
- Jun 2023
- First submitted
- 31 Mar 2018
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veil-preserving Versus Standard Holmium Laser Enucleation of the Prostate: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03494049
- Acronym / sponsor ID
- MansprostIV / RP.19.11.49
- Conditions
- Post Prostatectomy Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 22 Apr 2016 (actual)
- Primary completion
- 8 Dec 2020 (actual)
- Study completion
- 12 Dec 2021 (actual)
- First posted
- 11 Apr 2018 (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.
Postoperative transient stress urine leakage following Holmium laser enucleation of the prostate is one of the problems that frustrate both surgeon and patients
Standard HoLEP might be associated with some stretch of the sphincter and de-epithelization of the sphincter area anteriorly.
In Veil preserving HoLEP, early separation of the adenoma from the sphincter ring minimizes sphincter stretch. Furthermore, more proximal incision of the 12 O'clock mucosal strip sparring a veil of mucosa covering the sphincter ring.
Our hypothesis is that by this technique the early postoperative transient urine leak would be minimized and duration of leakage if anny would be shortened.
Detailed description
Postoperative transient stress urine leakage following Holmium laser enucleation of the prostate is one of the problems that frustrate both surgeon and patients.
Many reports addressed different variables for the cause of post HoLEP urine leakage. Looking for a procedure done by a single surgeon who had tremendous experience of this procedure may enable investigators to identify precisely technical points of interest that may affect post HoLEP stress urine incontinence.
Standard HoLEP might be associated with some stretch of the sphincter and de-epithelization of the sphincter area anteriorly.
In Veil preserving HoLEP, early separation of the adenoma from the sphincter ring minimizes sphincter stretch. Furthermore, more proximal incision of the 12 O'clock mucosal strip sparring a veil of mucosa covering the sphincter ring.
Investigators' hypothesis is that by this technique the early postoperative transient urine leak would be minimized and duration of leakage if any would be shortened.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Veil sparring HoLEP | Active comparator | Procedure: Veil sparring HoLEPEarly mucosal incision lateral to the Veru followed by early separation of the adenoma from the sphincter ring after identification of the plane of enucleation, this minimizes sphincter stretch. Furthermore, more proximal incision of the 12 O'clock mucosal strip sparring a veil of mucosa covering the sphincter ring. |
| Standard HoLEP | Active comparator | Procedure: Standard HoLEPStandard HoLEP TECHNIQUE as described by Elhilali et al 2010 |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients' age ≥50 years
- ASA (American society of anesthesiologists) score ≤3.
- TRUS estimated weight ≥40 grams.
Key exclusion criteria (7 listed)
- Patient with neurological disorder which might affect bladder function as cerebrovascular stroke or Parkinson disease.
- Active urinary tract infection.
- Presence of bladder cancer (within the last 2 years).
- Prostate cancer patients.
- Patients with bleeding tendency, ongoing anticoagulants or antiplatelet medications
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 |
|---|---|---|
| Veil sparring HoLEPAlso: early apical separationEarly mucosal incision; lateral to the Veru and proximal to the apical bulge of the adenoma, followed by early separation of the adenoma from the sphincter ring after identification of the plane of enucleation, this minimizes sphincter stretch. Furthermore, more proximal incision of the 12 O'clock mucosal strip sparring a veil of mucosa covering the sphincter ring. | Procedure or surgery | Veil sparring HoLEP |
| Standard HoLEPHolmium laser enucleation of the prostate in the standard approach described by Elhilali et al 2010 | Procedure or surgery | Standard HoLEP |
Primary outcome
urine incontinence
Time frame: 1 month postoperative
one hour pad test for post prostatectomy incontinence, scale from 0 to 4, the higher the more incontinence
4 secondary outcomes
international prostate symptom score
Time frame: 1 year
urine flow rate
Time frame: 1 year
urine incontinence
Time frame: 4 months postoperative
International Consultation on Incontinence Questionnaire Short-Form
Time frame: one month postoperative
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 15 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Post Prostatectomy Incontinence
Active, not recruiting
ExMI vs. Biofeedback PFMT for Post-Prostatectomy Incontinence
Post-Prostatectomy Urinary Incontinence, Benign Prostatic Hyperplasia
Not yet recruiting
The Effect of Pelvic Floor Muscle Exercises After Radical Prostatectomy
Prostate Cancer (Post Prostatectomy), Urinary Incontinence (UI)
Recruiting
The Effect of Mobile-Based Perioperative Education on Urinary Incontinence and Erectile Function After Radical Prostatectomy
Prostate Cancer (Post Prostatectomy), Urinary Incontinence (UI)
Recruiting
Efficacy of Extracorporeal Magnetic Stimulation, Pelvic Floor Muscle Exercise, and Combination of Both in Management of Post Radical Prostatectomy Urinary Incontinence
Post Radical Prostatectomy Urinary Incontinence
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 Elshal principal investigator
Mansoura 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 Veil sparring HoLEP and Standard HoLEP in people with Post Prostatectomy Incontinence, 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 15 Jun 2023. 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?
urine incontinence (time frame: 1 month postoperative). 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 15 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.