Benign Prostatic Hyperplasia (BPH)NCT04178811
HoLEP in Management of BPH Patients With Predominant Voiding vs Storage LUTS: A Comparative Retrospective Study
An observational study of Benign Prostatic Hyperplasia (BPH), run by Assiut University at 1 site in Egypt.
Trial summary
Comparison in outcomes of a minimally invasive surgical modality (Holmium Laser Enucleation of Prostate) in management of voiding versus storage lower urinary tract symptoms associated with Benign Prostatic Hyperplasia Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- Holmium Laser Enucleation of Prostate
- Type of treatment
- Medical device
- How many people
- 132 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 Apr 2022
- Phase
- Observational
- 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
Study population: BPH patients who underwent HoLEP for either predominant voiding or predominant storage LUTS
- Inclusion criteria: BPH patients who underwent HoLEP for either predominant voiding or predominant storage LUTS
- Exclusion criteria:
- Active UTI.
- PSA ˃ 10 ng/mL (unless negative prostatic biopsy).
- Prostatitis within past year.
- Previous BPH surgery.
- BPH with concomitant bladder stones.
- BPH with concomitant neurogenic bladder.
- BPH patients with predominant storage LUTS along with PVR of 150 ml or more.
- BPH patients taking medications that may mimic or aggravate the LUTS such as antidepressants, diuretics, bronchodilators, anticholinergics, sympathomimetics, and antihistamines (84).
- BPH patients having uncontrolled DM or recurrent UTIs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Holmium Laser Enucleation of Prostate in Management of Benign Prostatic Hyperplasia Patients With Predominant Voiding Versus Storage Lower Urinary Tract Symptoms: A Comparative Retrospective Study
Comparison in outcomes of a minimally invasive surgical modality (Holmium Laser Enucleation of Prostate) in management of voiding versus storage lower urinary tract symptoms associated with Benign Prostatic Hyperplasia
Read the detailed description
Benign prostatic hyperplasia (BPH) is a common condition affecting a large number of men over the age of 50 years and is the major cause of the highly prevalent lower urinary tract symptoms (LUTS) in men of this age group that often necessitate surgical intervention. The LUTS associated with BPH are generally divided into voiding symptoms (slow stream, splitting or spraying, intermittency, hesitancy, straining, terminal dribbling) and storage symptoms (day-time urinary frequency, nocturia, urgency, urinary incontinence). These LUTS are among the most common clinical complaints in adult men with reported increasing prevalence with aging. The storage LUTS may also be termed overactive bladder (OAB) symptoms and are largely encompassed by the term "overactive bladder syndrome" (OABS). While the voiding symptoms are usually more prevalent, the storage symptoms are almost always more bothersome. Associated with a significant burden on both patients and society, these LUTS also have a major impact on patients' quality of life (QoL). As such, The American Urological Association (AUA) has developed the International Prostate Symptom Score (IPSS) as one of the most reliable tools to evaluate the severity of LUTS associated with BPH which, in turn, plays a major role in determining the most appropriate treatment option for BPH.
After being the preferred surgical treatment for BPH patients for more than 30 years, transurethral resection of prostate (TURP) has been replaced by holmium laser enucleation of prostate (HoLEP) as the gold standard surgical treatment for BPH. Introduced in 1995, HoLEP is a minimally invasive surgical procedure that has become the first line treatment of BPH as it provides both effective and safe surgical treatment option for BPH without any size limitation, although at the expense of occasional complications. HoLEP has the advantage of enucleating the enlarging BPH adenoma without destroying the bladder neck thus relieving bladder outflow obstruction (BOO) immediately, safely, and effectively.
Although improvement in both storage and voiding LUTS has been demonstrated after either medical treatment with an alpha-blocker or a 5-alpha-reductase inhibitor or surgical treatment with TURP for BPH patients, few studies have been made to measure the outcomes of HoLEP in BPH-related voiding and/or storage LUTS.
We performed our study with the aim to evaluate and compare the effectiveness and safety of HoLEP in relieving either voiding or storage LUTS in BPH patients.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- Holmium Laser Enucleation of Prostate
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium Laser Enucleation of ProstateDevice
Use of Holmium Laser Enucleation of Prostate in management of Benign Prostatic Hyperplasia patients
| Study group | Role | What they receive |
|---|---|---|
| Benign Prostatic Hyperplasia patients with predominant voiding lower urinary tract symptoms | Outcomes of Holmium Laser Enucleation of Prostate in Management of Benign Prostatic Hyperplasia patients with predominant voiding lower urinary tract symptoms Receives: Device: Holmium Laser Enucleation of Prostate | |
| Benign Prostatic Hyperplasia patients with predominant storage lower urinary tract symptoms | Outcomes of Holmium Laser Enucleation of Prostate in Management of Benign Prostatic Hyperplasia patients with predominant storage lower urinary tract symptoms Receives: Device: Holmium Laser Enucleation of Prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficacy
Treatment efficacy which will be evaluated by comparing the preoperative urodynamics study (UDS) parameters, patient symptomatology, and international prostate symptom score (IPSS) with their postoperative counterparts.
International Prostate Symptom Score (IPSS) Minimum Score is Zero. Maximum Score is 35. 0-7 means mildly symptomatic and so good outcome. 8-19 means moderately symptomatic and so worse outcome. 20-35 means severely symptomatic and so worst outcome. Briefly,The lower the score, the better the outcome.
Measured: Six months
Secondary outcomes (1)
Treatment safety
Treatment safety which will be evaluated by collected and analysing any reported complication within the first 6 postoperative months.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Aug 2021
- Primary completion1 Mar 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohamed Atef Abdelaziz Mostafa, Assiut University
- Investigators
- Mahmoud Khalil, MD, Study director, Assiut UniversityMohamed A El-Gammal, MD, Study director, Assiut UniversityMohamed A Sayed, MD, Study director, Assiut UniversityAyman Mahdy, MD, Study chair, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178811
- Sponsor's protocol ID
- Benign Prostatic Hyperplasia
- Status last verified
- Dec 2022
- First submitted
- 25 Nov 2019
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Porreca A, D'Agostino D, Vigo M, Corsi P, Romagnoli D, Del Rosso A, Schiavina R, Brunocilla E, Artibani W, Giampaoli M. "In-bore" MRI prostate biopsy is a safe preoperative clinical tool to exclude significant prostate cancer in symptomatic patients with benign prostatic obstruction before transurethral laser enucleation. Arch Ital Urol Androl. 2020 Jan 14;91(4):224-229. doi: 10.4081/aiua.2019.4.224.
PubMed 31937084Lee YJ, Oh SA, Kim SH, Oh SJ. Patient satisfaction after holmium laser enucleation of the prostate (HoLEP): A prospective cohort study. PLoS One. 2017 Aug 9;12(8):e0182230. doi: 10.1371/journal.pone.0182230. eCollection 2017.
PubMed 28793314Gratzke C, Schlenker B, Seitz M, Karl A, Hermanek P, Lack N, Stief CG, Reich O. Complications and early postoperative outcome after open prostatectomy in patients with benign prostatic enlargement: results of a prospective multicenter study. J Urol. 2007 Apr;177(4):1419-22. doi: 10.1016/j.juro.2006.11.062.
PubMed 17382744Martin SA, Haren MT, Marshall VR, Lange K, Wittert GA; Members of the Florey Adelaide Male Ageing Study. Prevalence and factors associated with uncomplicated storage and voiding lower urinary tract symptoms in community-dwelling Australian men. World J Urol. 2011 Apr;29(2):179-84. doi: 10.1007/s00345-010-0605-8. Epub 2010 Oct 21.
PubMed 20963421Saito K, Hisasue S, Ide H, Aoki H, Muto S, Yamaguchi R, Tsujimura A, Horie S. The Impact of Increased Bladder Blood Flow on Storage Symptoms after Holmium Laser Enucleation of the Prostate. PLoS One. 2015 Jun 19;10(6):e0129111. doi: 10.1371/journal.pone.0129111. eCollection 2015.
PubMed 26090819Peters TJ, Donovan JL, Kay HE, Abrams P, de la Rosette JJ, Porru D, Thuroff JW. The International Continence Society "Benign Prostatic Hyperplasia" Study: the botherosomeness of urinary symptoms. J Urol. 1997 Mar;157(3):885-9.
PubMed 9072592Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
PubMed 25613154Rodrigues P, Meller A, Campagnari JC, Alcantara D, D'Imperio M. International Prostate Symptom Score--IPSS-AUA as discriminat scale in 400 male patients with lower urinary tract symptoms (LUTS). Int Braz J Urol. 2004 Mar-Apr;30(2):135-41. doi: 10.1590/s1677-55382004000200011.
PubMed 15703098Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992 Nov;148(5):1549-57; discussion 1564. doi: 10.1016/s0022-5347(17)36966-5.
PubMed 1279218O'Leary MP, Wei JT, Roehrborn CG, Miner M; BPH Registry and Patient Survey Steering Committee. Correlation of the International Prostate Symptom Score bother question with the Benign Prostatic Hyperplasia Impact Index in a clinical practice setting. BJU Int. 2008 Jun;101(12):1531-5. doi: 10.1111/j.1464-410X.2008.07574.x. Epub 2008 Apr 28.
PubMed 18445080Jeong J, Lee HS, Cho WJ, Jung W, You HW, Kim TH, Sung HH, Lee KS. Effect of Detrusor Overactivity on Functional Outcomes After Holmium Laser Enucleation of the Prostate in Patients With Benign Prostatic Obstruction. Urology. 2015 Jul;86(1):133-8. doi: 10.1016/j.urology.2015.03.033. Epub 2015 May 16.
PubMed 25991576
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holmium Laser Enucleation of Prostate in Management of Benign Prostatic Hyperplasia Patients With Predominant Voiding Versus Storage Lower Urinary Tract Symptoms: A Comparative Retrospective Study
- ClinicalTrials.gov ID
- NCT04178811
- Acronym / sponsor ID
- Benign Prostatic Hyperplasia
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 26 Nov 2019 (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.
Comparison in outcomes of a minimally invasive surgical modality (Holmium Laser Enucleation of Prostate) in management of voiding versus storage lower urinary tract symptoms associated with Benign Prostatic Hyperplasia
Detailed description
Benign prostatic hyperplasia (BPH) is a common condition affecting a large number of men over the age of 50 years and is the major cause of the highly prevalent lower urinary tract symptoms (LUTS) in men of this age group that often necessitate surgical intervention. The LUTS associated with BPH are generally divided into voiding symptoms (slow stream, splitting or spraying, intermittency, hesitancy, straining, terminal dribbling) and storage symptoms (day-time urinary frequency, nocturia, urgency, urinary incontinence). These LUTS are among the most common clinical complaints in adult men with reported increasing prevalence with aging. The storage LUTS may also be termed overactive bladder (OAB) symptoms and are largely encompassed by the term "overactive bladder syndrome" (OABS). While the voiding symptoms are usually more prevalent, the storage symptoms are almost always more bothersome. Associated with a significant burden on both patients and society, these LUTS also have a major impact on patients' quality of life (QoL). As such, The American Urological Association (AUA) has developed the International Prostate Symptom Score (IPSS) as one of the most reliable tools to evaluate the severity of LUTS associated with BPH which, in turn, plays a major role in determining the most appropriate treatment option for BPH.
After being the preferred surgical treatment for BPH patients for more than 30 years, transurethral resection of prostate (TURP) has been replaced by holmium laser enucleation of prostate (HoLEP) as the gold standard surgical treatment for BPH. Introduced in 1995, HoLEP is a minimally invasive surgical procedure that has become the first line treatment of BPH as it provides both effective and safe surgical treatment option for BPH without any size limitation, although at the expense of occasional complications. HoLEP has the advantage of enucleating the enlarging BPH adenoma without destroying the bladder neck thus relieving bladder outflow obstruction (BOO) immediately, safely, and effectively.
Although improvement in both storage and voiding LUTS has been demonstrated after either medical treatment with an alpha-blocker or a 5-alpha-reductase inhibitor or surgical treatment with TURP for BPH patients, few studies have been made to measure the outcomes of HoLEP in BPH-related voiding and/or storage LUTS.
We performed our study with the aim to evaluate and compare the effectiveness and safety of HoLEP in relieving either voiding or storage LUTS in BPH patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benign Prostatic Hyperplasia patients with predominant voiding lower urinary tract symptoms | – | Device: Holmium Laser Enucleation of ProstateOutcomes of Holmium Laser Enucleation of Prostate in Management of Benign Prostatic Hyperplasia patients with predominant voiding lower urinary tract symptoms |
| Benign Prostatic Hyperplasia patients with predominant storage lower urinary tract symptoms | – | Device: Holmium Laser Enucleation of ProstateOutcomes of Holmium Laser Enucleation of Prostate in Management of Benign Prostatic Hyperplasia patients with predominant storage lower urinary tract symptoms |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- BPH patients who underwent HoLEP for either predominant voiding or predominant storage LUTS
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 |
|---|---|---|
| Holmium Laser Enucleation of ProstateUse of Holmium Laser Enucleation of Prostate in management of Benign Prostatic Hyperplasia patients | Device | Benign Prostatic Hyperplasia patients with predominant storage lower urinary tract symptoms, Benign Prostatic Hyperplasia patients with predominant voiding lower urinary tract symptoms |
Primary outcome
Treatment efficacy
Time frame: Six months
Treatment efficacy which will be evaluated by comparing the preoperative urodynamics study (UDS) parameters, patient symptomatology, and international prostate symptom score (IPSS) with their postoperative counterparts. International Prostate Symptom Score (IPSS) Minimum Score is Zero. Maximum Score is 35. 0-7 means mildly symptomatic and so good outcome. 8-19 means moderately symptomatic and so worse outcome. 20-35 means severely symptomatic and so worst outcome. Briefly,The lower the score, the better the outcome.
1 secondary outcome
Treatment safety
Time frame: Six months
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 20 Dec 2022.
- Background: PubMed 31937084Porreca A, D'Agostino D, Vigo M, Corsi P, Romagnoli D, Del Rosso A, Schiavina R, Brunocilla E, Artibani W, Giampaoli M. "In-bore" MRI prostate biopsy is a safe preoperative clinical tool to exclude significant prostate cancer in symptomatic patients with benign prostatic obstruction before transurethral laser enucleation. Arch Ital Urol Androl. 2020 Jan 14;91(4):224-229. doi: 10.4081/aiua.2019.4.224.
- Background: PubMed 28793314Lee YJ, Oh SA, Kim SH, Oh SJ. Patient satisfaction after holmium laser enucleation of the prostate (HoLEP): A prospective cohort study. PLoS One. 2017 Aug 9;12(8):e0182230. doi: 10.1371/journal.pone.0182230. eCollection 2017.
- Background: PubMed 17382744Gratzke C, Schlenker B, Seitz M, Karl A, Hermanek P, Lack N, Stief CG, Reich O. Complications and early postoperative outcome after open prostatectomy in patients with benign prostatic enlargement: results of a prospective multicenter study. J Urol. 2007 Apr;177(4):1419-22. doi: 10.1016/j.juro.2006.11.062.
- Background: PubMed 20963421Martin SA, Haren MT, Marshall VR, Lange K, Wittert GA; Members of the Florey Adelaide Male Ageing Study. Prevalence and factors associated with uncomplicated storage and voiding lower urinary tract symptoms in community-dwelling Australian men. World J Urol. 2011 Apr;29(2):179-84. doi: 10.1007/s00345-010-0605-8. Epub 2010 Oct 21.
- Background: PubMed 26090819Saito K, Hisasue S, Ide H, Aoki H, Muto S, Yamaguchi R, Tsujimura A, Horie S. The Impact of Increased Bladder Blood Flow on Storage Symptoms after Holmium Laser Enucleation of the Prostate. PLoS One. 2015 Jun 19;10(6):e0129111. doi: 10.1371/journal.pone.0129111. eCollection 2015.
- Background: PubMed 9072592Peters TJ, Donovan JL, Kay HE, Abrams P, de la Rosette JJ, Porru D, Thuroff JW. The International Continence Society "Benign Prostatic Hyperplasia" Study: the botherosomeness of urinary symptoms. J Urol. 1997 Mar;157(3):885-9.
- Background: PubMed 25613154Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
- Background: PubMed 15703098Rodrigues P, Meller A, Campagnari JC, Alcantara D, D'Imperio M. International Prostate Symptom Score--IPSS-AUA as discriminat scale in 400 male patients with lower urinary tract symptoms (LUTS). Int Braz J Urol. 2004 Mar-Apr;30(2):135-41. doi: 10.1590/s1677-55382004000200011.
- Background: PubMed 1279218Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992 Nov;148(5):1549-57; discussion 1564. doi: 10.1016/s0022-5347(17)36966-5.
- Background: PubMed 18445080O'Leary MP, Wei JT, Roehrborn CG, Miner M; BPH Registry and Patient Survey Steering Committee. Correlation of the International Prostate Symptom Score bother question with the Benign Prostatic Hyperplasia Impact Index in a clinical practice setting. BJU Int. 2008 Jun;101(12):1531-5. doi: 10.1111/j.1464-410X.2008.07574.x. Epub 2008 Apr 28.
- Background: PubMed 25991576Jeong J, Lee HS, Cho WJ, Jung W, You HW, Kim TH, Sung HH, Lee KS. Effect of Detrusor Overactivity on Functional Outcomes After Holmium Laser Enucleation of the Prostate in Patients With Benign Prostatic Obstruction. Urology. 2015 Jul;86(1):133-8. doi: 10.1016/j.urology.2015.03.033. Epub 2015 May 16.
- 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.
Mahmoud Khalil, MD study director
Assiut University
Mohamed A El-Gammal, MD study director
Assiut University
Mohamed A Sayed, MD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia (BPH), run by Assiut 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 20 Dec 2022. 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?
Treatment efficacy (time frame: Six months). 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 NCT04178811, which also lists 11 linked publications.
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 20 Dec 2022.