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

Benign Prostatic Hyperplasia (BPH) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04178811
• Other study ID #: Benign Prostatic Hyperplasia
• Status: Completed
• Start date: August 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: December 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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preferred surgical treatment for BPH patients for more than 30 years, transurethral resection of prostate (TURP) has been replaced by holmium laser enucleation of prostate (HoLEP) as the gold standard surgical treatment for BPH.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: April 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

1. Inclusion criteria:

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

2. 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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Six months
Secondary	Treatment safety	Treatment safety which will be evaluated by collected and analysing any reported complication within the first 6 postoperative months.	Six months