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

NCT04178811 | Completed

• 1 other identifier: Benign Prostatic Hyperplasia
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Benign Prostatic Hyperplasia (BPH)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Treatment safety

  Six months

Study Arms (2)

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

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

Device: Holmium Laser Enucleation of Prostate

Interventions

Holmium Laser Enucleation of Prostate 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; Benign Prostatic Hyperplasia patients with predominant voiding lower urinary tract symptoms

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine Assiut University

Asyut, 71515, Egypt

Location

Related Publications (11)

• 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.

  PMID: 31937084 BACKGROUND

• 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.

  PMID: 28793314 BACKGROUND

• 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.

  PMID: 17382744 BACKGROUND

• 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.

  PMID: 20963421 BACKGROUND

• 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.

  PMID: 26090819 BACKGROUND

• 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.

  PMID: 9072592 BACKGROUND

• 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.

  PMID: 25613154 BACKGROUND

• 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.

  PMID: 15703098 BACKGROUND

• 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.

  PMID: 1279218 BACKGROUND

• 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.

  PMID: 18445080 BACKGROUND

• 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.

  PMID: 25991576 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Mahmoud Khalil, MD

  Assiut University

  STUDY DIRECTOR

• Mohamed A El-Gammal, MD

  Assiut University

  STUDY DIRECTOR

• Mohamed A Sayed, MD

  Assiut University

  STUDY DIRECTOR

• Ayman Mahdy, MD

  University of Cincinnati

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 26, 2019
• Study Start: August 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)