Prostatic HyperplasiaNCT04561505
HoLEP vs mTURP in Management of Benign Prostatic Hyperplasia
A study testing Holmium laser enucleation of prostate and monopolar transurethral resection of prostate in people with Prostatic Hyperplasia, run by Ain Shams University at 1 site in Egypt.
Trial summary
To compare the clinical outcome regarding safety and efficacy between Holmium laser enucleation of the prostate and transurethral resection of the prostate in management of benign prostatic hyperplasia. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Holmium laser enucleation of prostate and monopolar transurethral resection of prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 29 Feb 2020
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- prostate volume less than 80 ml
- high IPSS more than 19 affecting quality of life
- recurrent urinary retention with failure of medical treatment
- recurrent urinary tract infection
- affection of upper urinary tract
- refractory hematuria
- bladder stones
- bladder diverticula
Who cannot join
- patients with neurogenic bladder
- patients with previous prostate or urethral surgery
- associated urethral stricture
- prostate cancer diagnosed by TRUS biopsy
- prostate volume more than 80 ml
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Holmium Laser Enucleation of the Prostate Versus Monopolar Transurethral Resection of the Prostate in Management of Benign Prostatic Hyperplasia.
To compare the clinical outcome regarding safety and efficacy between Holmium laser enucleation of the prostate and transurethral resection of the prostate in management of benign prostatic hyperplasia.
Read the detailed description
Benign prostatic hyperplasia (BPH) affects 70% of men older than 70 years and is a significant cause of morbidity in this population.
The symptoms of BPH include impaired physiological and functional well-being, which interferes with daily living.
Lower urinary tract symptoms (LUTS) in elderly men are mainly related to an enlarged prostate, the actual link between an enlarged prostate and the onset of symptoms are multifactorial.
LUTS include both irritative symptoms in the form of urgency, frequency, nocturnal enuresis and urge incontinence as well as obstructive symptoms comprise hesitancy, weak interrupted stream of urine, incomplete voiding which eventually affect the quality of life (QoL), the main goal of treatment is resolve these symptom.
Multiple surgical options are available for management of benign prostatic hyperplasia (BPH) and its associated symptoms. Transurethral resection of the prostate (TURP) and open prostatectomy remain the gold standard surgical management. However, considerable morbidities are associated with both procedures and mainly related to the prostate size.
These complications may be either patient or surgically related. The patient's related complications are cardiac arrhythmia, myocardial infarction, pulmonary embolism, exacerbation of previous respiratory disease, deep venous thrombosis and death. The surgical related complication includes bleeding, capsular perforation, urosepsis, incontinence, conversion to open surgery, bladder neck stenosis, redo surgery and transurethral resection syndrome.
Clearly, a wide gap existed between simple medical therapy on one hand and TURP on the other hand. This wide gap is coupled with the need for a less morbid alternative to TURP that led to the emergence of various less invasive therapy among which Laser based minimally invasive procedure.
Modern laser therapy for BPH has advantages over TURP including decreased blood loss and minimal serum electrolyte changes resulting in fewer cardiovascular complications, decreased catheter time, shorter hospital stay and the ability to treat patients on anticoagulation.
Because of these potential advantages, there has been a shift in practice patterns with laser procedures accounting for 57% of surgical interventions for BPH, compared to traditional TURP which accounted for only 39% of interventions in 2005.
Holmium laser enucleation of the prostate (HoLEP) is the most recent step in the evolution of holmium laser prostatectomy. HoLEP is a safe and effective surgical procedure, which has comparable results to transurethral resection of the prostate (TURP) and open prostatectomy, with low morbidity and short hospital stay.
HoLEP is equally suitable for small, medium, and large prostate glands, with clinical outcomes that are independent of prostate size, and recently it has been proposed as a new gold standard for treatment of symptomatic benign prostatic hyperplasia (BPH). Currently, all BPH guidelines recommend HoLEP as a surgical treatment of BPH.
For a procedure to be considered a gold standard, it must provide effective results, low morbidity, and durable outcomes. HoLEP, as many of the new alternative treatments for symptomatic BPH, has scanty data regarding its role in Egyptian population and if it can replace TURP to be the gold standard.
To our best knowledge, no one estimated cost effectiveness between the two techniques in a developing country.
Our study aimed to compare the efficacy, safety and cost effectiveness of HoLEP versus monopolar TURP in management of benign prostatic hyperplasia in a developing country.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Holmium laser enucleation of prostate, monopolar transurethral resection of prostate
- Keywords
- prostate, transurethral resection of prostate, HoLEP
- 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 prostateProcedure or surgery
surgical management of BPH by Holmium laser enucleation using 0.9% saline fluid for irrigation
monopolar transurethral resection of prostateProcedure or surgery
surgical management of BPH by monopolar TURP using distilled water for irrigation
| Study group | Role | What they receive |
|---|---|---|
| Holmium laser enucleation of prostate | Active comparator | patients that undergo Holmium laser enucleation of prostate (HoLEP) procedure Receives: Procedure: Holmium laser enucleation of prostate |
| monopolar transurethral resection of prostate | Active comparator | patients that undergo monopolar transurethral resection of prostate Receives: Procedure: monopolar transurethral resection of prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
the international prostate symptom score (IPSS)
assessing the improvement of IPSS
Measured: 1 year
maximum urine flow rate (Qmax)
assessing the improvement of Qmax
Measured: 1 year
Secondary outcomes (8)
operative time
estimating the operative time in both groups in minutes
Measured: immediately postoperative
resected volume
measuring the resected volume of prostate after each operation
Measured: immediately postoperative
postoperative drop in hemaoglobin level
comparing postoperative hemoglobin level with preoperative level in both groups
Measured: 1 day postoperative
postoperative drop in sodium level
comparing postoperative sodium level with preoperative level in both groups
Measured: 1 day postoperative
postoperative catheterization time
assessing postoperative catheterization time in both groups
Measured: 4 days postoperative
duration of hospital stay
assessing duration of hospital stay in both groups
Measured: 3 days postoperative
postvoiding residual urine volume
assessing postvoiding residual urine volume in both groups
Measured: 1 year
ultrasound assessed prostate volume
comparing ultrasound assessed prostate volume in both groups
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 posted23 Sep 2020
- Study start1 Feb 2018
- Primary completion1 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salah Sayed, Ain Shams University
- Investigators
- Salah Sayed, master, Principal investigator, assistant lecturer of urology, Ainshams university hospital, Cairo, EgyptAmr Elshorbagy, PhD, Study chair, professor of urology, Ainshams university hospital, Cairo, EgyptMahmoud A. Mahmoud, PhD, Study chair, assistant professor of urology, Ainshams university hospital, Cairo, EgyptDiaaeldin Mostafa, PhD, Study director, assistant professor of urology, Ainshams university hospital, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561505
- Sponsor's protocol ID
- HoLEP
- Status last verified
- Sep 2020
- First submitted
- 18 Sep 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Magoha GA. Medical management of benign prostatic hyperplasia: a review. East Afr Med J. 1996 Jul;73(7):453-6.
PubMed 8918007Oelke M, Bachmann A, Descazeaud A, Emberton M, Gravas S, Michel MC, N'dow J, Nordling J, de la Rosette JJ; European Association of Urology. EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol. 2013 Jul;64(1):118-40. doi: 10.1016/j.eururo.2013.03.004. Epub 2013 Mar 13.
PubMed 23541338Biester K, Skipka G, Jahn R, Buchberger B, Rohde V, Lange S. Systematic review of surgical treatments for benign prostatic hyperplasia and presentation of an approach to investigate therapeutic equivalence (non-inferiority). BJU Int. 2012 Mar;109(5):722-30. doi: 10.1111/j.1464-410X.2011.10512.x. Epub 2011 Aug 22.
PubMed 21883855Bach T, Muschter R, Sroka R, Gravas S, Skolarikos A, Herrmann TR, Bayer T, Knoll T, Abbou CC, Janetschek G, Bachmann A, Rassweiler JJ. Laser treatment of benign prostatic obstruction: basics and physical differences. Eur Urol. 2012 Feb;61(2):317-25. doi: 10.1016/j.eururo.2011.10.009. Epub 2011 Oct 21.
PubMed 22033173Rassweiler J, Teber D, Kuntz R, Hofmann R. Complications of transurethral resection of the prostate (TURP)--incidence, management, and prevention. Eur Urol. 2006 Nov;50(5):969-79; discussion 980. doi: 10.1016/j.eururo.2005.12.042. Epub 2006 Jan 30.
PubMed 16469429Pearce SM, Pariser JJ, Malik RD, Famakinwa OJ, Chung DE. Outcomes following Thulium vapoenucleation of large prostates. Int Braz J Urol. 2016 Jul-Aug;42(4):757-65. doi: 10.1590/S1677-5538.IBJU.2015.0424.
PubMed 27564287Yu X, Elliott SP, Wilt TJ, McBean AM. Practice patterns in benign prostatic hyperplasia surgical therapy: the dramatic increase in minimally invasive technologies. J Urol. 2008 Jul;180(1):241-5; discussion 245. doi: 10.1016/j.juro.2008.03.039. Epub 2008 May 21.
PubMed 18499180Elzayat EA, Elhilali MM. Holmium laser enucleation of the prostate (HoLEP): the endourologic alternative to open prostatectomy. Eur Urol. 2006 Jan;49(1):87-91. doi: 10.1016/j.eururo.2005.08.015. Epub 2005 Nov 2.
PubMed 16314033Kuntz RM, Lehrich K, Ahyai S. Does perioperative outcome of transurethral holmium laser enucleation of the prostate depend on prostate size? J Endourol. 2004 Mar;18(2):183-8. doi: 10.1089/089277904322959842.
PubMed 15072628Kuntz RM. Current role of lasers in the treatment of benign prostatic hyperplasia (BPH). Eur Urol. 2006 Jun;49(6):961-9. doi: 10.1016/j.eururo.2006.03.028. Epub 2006 Mar 31.
PubMed 16632179
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holmium Laser Enucleation of the Prostate Versus Monopolar Transurethral Resection of the Prostate in Management of Benign Prostatic Hyperplasia.
- ClinicalTrials.gov ID
- NCT04561505
- Acronym / sponsor ID
- HoLEP
- Conditions
- Prostatic Hyperplasia
- Keywords
- prostate, transurethral resection of prostate, HoLEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 23 Sep 2020 (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.
To compare the clinical outcome regarding safety and efficacy between Holmium laser enucleation of the prostate and transurethral resection of the prostate in management of benign prostatic hyperplasia.
Detailed description
Benign prostatic hyperplasia (BPH) affects 70% of men older than 70 years and is a significant cause of morbidity in this population.
The symptoms of BPH include impaired physiological and functional well-being, which interferes with daily living.
Lower urinary tract symptoms (LUTS) in elderly men are mainly related to an enlarged prostate, the actual link between an enlarged prostate and the onset of symptoms are multifactorial.
LUTS include both irritative symptoms in the form of urgency, frequency, nocturnal enuresis and urge incontinence as well as obstructive symptoms comprise hesitancy, weak interrupted stream of urine, incomplete voiding which eventually affect the quality of life (QoL), the main goal of treatment is resolve these symptom.
Multiple surgical options are available for management of benign prostatic hyperplasia (BPH) and its associated symptoms. Transurethral resection of the prostate (TURP) and open prostatectomy remain the gold standard surgical management. However, considerable morbidities are associated with both procedures and mainly related to the prostate size.
These complications may be either patient or surgically related. The patient's related complications are cardiac arrhythmia, myocardial infarction, pulmonary embolism, exacerbation of previous respiratory disease, deep venous thrombosis and death. The surgical related complication includes bleeding, capsular perforation, urosepsis, incontinence, conversion to open surgery, bladder neck stenosis, redo surgery and transurethral resection syndrome.
Clearly, a wide gap existed between simple medical therapy on one hand and TURP on the other hand. This wide gap is coupled with the need for a less morbid alternative to TURP that led to the emergence of various less invasive therapy among which Laser based minimally invasive procedure.
Modern laser therapy for BPH has advantages over TURP including decreased blood loss and minimal serum electrolyte changes resulting in fewer cardiovascular complications, decreased catheter time, shorter hospital stay and the ability to treat patients on anticoagulation.
Because of these potential advantages, there has been a shift in practice patterns with laser procedures accounting for 57% of surgical interventions for BPH, compared to traditional TURP which accounted for only 39% of interventions in 2005.
Holmium laser enucleation of the prostate (HoLEP) is the most recent step in the evolution of holmium laser prostatectomy. HoLEP is a safe and effective surgical procedure, which has comparable results to transurethral resection of the prostate (TURP) and open prostatectomy, with low morbidity and short hospital stay.
HoLEP is equally suitable for small, medium, and large prostate glands, with clinical outcomes that are independent of prostate size, and recently it has been proposed as a new gold standard for treatment of symptomatic benign prostatic hyperplasia (BPH). Currently, all BPH guidelines recommend HoLEP as a surgical treatment of BPH.
For a procedure to be considered a gold standard, it must provide effective results, low morbidity, and durable outcomes. HoLEP, as many of the new alternative treatments for symptomatic BPH, has scanty data regarding its role in Egyptian population and if it can replace TURP to be the gold standard.
To our best knowledge, no one estimated cost effectiveness between the two techniques in a developing country.
Our study aimed to compare the efficacy, safety and cost effectiveness of HoLEP versus monopolar TURP in management of benign prostatic hyperplasia in a developing country.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Holmium laser enucleation of prostate | Active comparator | Procedure: Holmium laser enucleation of prostatepatients that undergo Holmium laser enucleation of prostate (HoLEP) procedure |
| monopolar transurethral resection of prostate | Active comparator | Procedure: monopolar transurethral resection of prostatepatients that undergo monopolar transurethral resection of prostate |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- prostate volume less than 80 ml
- high IPSS more than 19 affecting quality of life
- recurrent urinary retention with failure of medical treatment
- recurrent urinary tract infection
- affection of upper urinary tract
Key exclusion criteria (5 listed)
- patients with neurogenic bladder
- patients with previous prostate or urethral surgery
- associated urethral stricture
- prostate cancer diagnosed by TRUS biopsy
- prostate volume more than 80 ml
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 prostatesurgical management of BPH by Holmium laser enucleation using 0.9% saline fluid for irrigation | Procedure or surgery | Holmium laser enucleation of prostate |
| monopolar transurethral resection of prostatesurgical management of BPH by monopolar TURP using distilled water for irrigation | Procedure or surgery | monopolar transurethral resection of prostate |
Primary outcome
the international prostate symptom score (IPSS)
Time frame: 1 year
assessing the improvement of IPSS
maximum urine flow rate (Qmax)
Time frame: 1 year
assessing the improvement of Qmax
8 secondary outcomes
operative time
Time frame: immediately postoperative
resected volume
Time frame: immediately postoperative
postoperative drop in hemaoglobin level
Time frame: 1 day postoperative
postoperative drop in sodium level
Time frame: 1 day postoperative
postoperative catheterization time
Time frame: 4 days postoperative
duration of hospital stay
Time frame: 3 days postoperative
postvoiding residual urine volume
Time frame: 1 year
ultrasound assessed prostate volume
Time frame: 1 year
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 23 Sep 2020.
- Background: PubMed 8918007Magoha GA. Medical management of benign prostatic hyperplasia: a review. East Afr Med J. 1996 Jul;73(7):453-6.
- Background: PubMed 23541338Oelke M, Bachmann A, Descazeaud A, Emberton M, Gravas S, Michel MC, N'dow J, Nordling J, de la Rosette JJ; European Association of Urology. EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol. 2013 Jul;64(1):118-40. doi: 10.1016/j.eururo.2013.03.004. Epub 2013 Mar 13.
- Background: PubMed 21883855Biester K, Skipka G, Jahn R, Buchberger B, Rohde V, Lange S. Systematic review of surgical treatments for benign prostatic hyperplasia and presentation of an approach to investigate therapeutic equivalence (non-inferiority). BJU Int. 2012 Mar;109(5):722-30. doi: 10.1111/j.1464-410X.2011.10512.x. Epub 2011 Aug 22.
- Background: PubMed 22033173Bach T, Muschter R, Sroka R, Gravas S, Skolarikos A, Herrmann TR, Bayer T, Knoll T, Abbou CC, Janetschek G, Bachmann A, Rassweiler JJ. Laser treatment of benign prostatic obstruction: basics and physical differences. Eur Urol. 2012 Feb;61(2):317-25. doi: 10.1016/j.eururo.2011.10.009. Epub 2011 Oct 21.
- Background: PubMed 16469429Rassweiler J, Teber D, Kuntz R, Hofmann R. Complications of transurethral resection of the prostate (TURP)--incidence, management, and prevention. Eur Urol. 2006 Nov;50(5):969-79; discussion 980. doi: 10.1016/j.eururo.2005.12.042. Epub 2006 Jan 30.
- Background: PubMed 27564287Pearce SM, Pariser JJ, Malik RD, Famakinwa OJ, Chung DE. Outcomes following Thulium vapoenucleation of large prostates. Int Braz J Urol. 2016 Jul-Aug;42(4):757-65. doi: 10.1590/S1677-5538.IBJU.2015.0424.
- Background: PubMed 18499180Yu X, Elliott SP, Wilt TJ, McBean AM. Practice patterns in benign prostatic hyperplasia surgical therapy: the dramatic increase in minimally invasive technologies. J Urol. 2008 Jul;180(1):241-5; discussion 245. doi: 10.1016/j.juro.2008.03.039. Epub 2008 May 21.
- Background: PubMed 16314033Elzayat EA, Elhilali MM. Holmium laser enucleation of the prostate (HoLEP): the endourologic alternative to open prostatectomy. Eur Urol. 2006 Jan;49(1):87-91. doi: 10.1016/j.eururo.2005.08.015. Epub 2005 Nov 2.
- Background: PubMed 15072628Kuntz RM, Lehrich K, Ahyai S. Does perioperative outcome of transurethral holmium laser enucleation of the prostate depend on prostate size? J Endourol. 2004 Mar;18(2):183-8. doi: 10.1089/089277904322959842.
- Background: PubMed 16632179Kuntz RM. Current role of lasers in the treatment of benign prostatic hyperplasia (BPH). Eur Urol. 2006 Jun;49(6):961-9. doi: 10.1016/j.eururo.2006.03.028. Epub 2006 Mar 31.
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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.
Salah Sayed, master principal investigator
assistant lecturer of urology, Ainshams university hospital, Cairo, Egypt
Amr Elshorbagy, PhD study chair
professor of urology, Ainshams university hospital, Cairo, Egypt
Mahmoud A. Mahmoud, PhD study chair
assistant professor of urology, Ainshams university hospital, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holmium laser enucleation of prostate and monopolar transurethral resection of prostate in people with 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?
The sponsor lists 8 inclusion and 5 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 23 Sep 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. 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?
the international prostate symptom score (IPSS) (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT04561505, which also lists 10 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 23 Sep 2020.