Clinical trial NCT04178811: HoLEP in Management of BPH Patients With Predominant Voiding vs Storage LUTS: A Comparative Retrospective Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostatic Hyperplasia (BPH)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 132
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: BPH patients who underwent HoLEP for either predominant voiding or predominant storage LUTS

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment efficacy
timeFrame: Six months
Secondary outcomes:
measure: Treatment safety
timeFrame: Six months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine Assiut University
Study officials:
affiliation: Assiut University
name: Mahmoud Khalil, MD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mohamed A El-Gammal, MD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mohamed A Sayed, MD
role: STUDY_DIRECTOR
affiliation: University of Cincinnati
name: Ayman Mahdy, MD
role: STUDY_CHAIR
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