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HoLEP in Management of BPH Patients With Predominant Voiding vs Storage LUTS: A Comparative Retrospective Study

NCT ID: NCT04178811

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-04-01

Brief Summary

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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

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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preferred surgical treatment for BPH patients for more than 30 years, transurethral resection of prostate (TURP) has been replaced by holmium laser enucleation of prostate (HoLEP) as the gold standard surgical treatment for BPH.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

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Benign Prostatic Hyperplasia (BPH)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Holmium Laser Enucleation of Prostate

Intervention Type DEVICE

Use of Holmium Laser Enucleation of Prostate in management of Benign Prostatic Hyperplasia patients

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

Holmium Laser Enucleation of Prostate

Intervention Type DEVICE

Use of Holmium Laser Enucleation of Prostate in management of Benign Prostatic Hyperplasia patients

Interventions

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Holmium Laser Enucleation of Prostate

Use of Holmium Laser Enucleation of Prostate in management of Benign Prostatic Hyperplasia patients

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

BPH patients who underwent HoLEP for either predominant voiding or predominant storage LUTS

Exclusion Criteria

1. Active UTI.
2. PSA ˃ 10 ng/mL (unless negative prostatic biopsy).
3. Prostatitis within past year.
4. Previous BPH surgery.
5. BPH with concomitant bladder stones.
6. BPH with concomitant neurogenic bladder.
7. BPH patients with predominant storage LUTS along with PVR of 150 ml or more.
8. BPH patients taking medications that may mimic or aggravate the LUTS such as antidepressants, diuretics, bronchodilators, anticholinergics, sympathomimetics, and antihistamines (84).
9. BPH patients having uncontrolled DM or recurrent UTIs.
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Mohamed Atef Abdelaziz Mostafa

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud Khalil, MD

Role: STUDY_DIRECTOR

Assiut University

Mohamed A El-Gammal, MD

Role: STUDY_DIRECTOR

Assiut University

Mohamed A Sayed, MD

Role: STUDY_DIRECTOR

Assiut University

Ayman Mahdy, MD

Role: STUDY_CHAIR

University of Cincinnati

Locations

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Faculty of Medicine Assiut University

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 31937084 (View on PubMed)

Lee 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.

Reference Type BACKGROUND
PMID: 28793314 (View on PubMed)

Gratzke 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.

Reference Type BACKGROUND
PMID: 17382744 (View on PubMed)

Martin 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.

Reference Type BACKGROUND
PMID: 20963421 (View on PubMed)

Saito 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.

Reference Type BACKGROUND
PMID: 26090819 (View on PubMed)

Peters 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.

Reference Type BACKGROUND
PMID: 9072592 (View on PubMed)

Gratzke 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.

Reference Type BACKGROUND
PMID: 25613154 (View on PubMed)

Rodrigues 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.

Reference Type BACKGROUND
PMID: 15703098 (View on PubMed)

Barry 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.

Reference Type BACKGROUND
PMID: 1279218 (View on PubMed)

O'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.

Reference Type BACKGROUND
PMID: 18445080 (View on PubMed)

Jeong 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.

Reference Type BACKGROUND
PMID: 25991576 (View on PubMed)

Other Identifiers

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Benign Prostatic Hyperplasia

Identifier Type: -

Identifier Source: org_study_id