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

December 18, 2022 updated by: Mostafa Mohamed Atef Abdelaziz Mostafa, Assiut University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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preferred surgical treatment for BPH patients for more than 30 years, transurethral resection of prostate (TURP) has been replaced by holmium laser enucleation of prostate (HoLEP) as the gold standard surgical treatment for BPH.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

Observational

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • faculty of medicine Assiut university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Device: Holmium Laser Enucleation of Prostate
Use of Holmium Laser Enucleation of Prostate in management of Benign Prostatic Hyperplasia patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment safety
Time Frame: Six months
Treatment safety which will be evaluated by collected and analysing any reported complication within the first 6 postoperative months.
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Mahmoud Khalil, MD, Assiut University
  • Study Director: Mohamed A El-Gammal, MD, Assiut University
  • Study Director: Mohamed A Sayed, MD, Assiut University
  • Study Chair: Ayman Mahdy, MD, University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

November 25, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (Actual)

November 26, 2019

Study Record Updates

Last Update Posted (Estimate)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 18, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • benign prostatic hyperplasia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Benign Prostatic Hyperplasia (BPH)

Clinical Trials on Holmium Laser Enucleation of Prostate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe