Clinical trial NCT06939140: Urinary Incontinence After Endoscopic Prostatectomy
Official title: Predictors of Urinary Incontinence After Endoscopic Transurethral Bipolar Prostatectomy: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Urinary Incontinence (UI)
Keywords: Stress Urinary Incontinence (SUI)
Urge Urinary Incontinence (UUI)
Benign Prostatic Hyperplasia (BPH)
Bipolar enucleation of the Prostate (BipolEP)
Bipolar transurethral reaction of the prostate (B-TURP)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 98
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Benign prostatic hyperplasia patients who will undergo endoscopic bipolar transurethral prostatectomy and develop urinary incontinence will be included in the study. Their preoperative and intraoperative data will be studied to identify if there is association between their preoperative and intraoperative parameters and the development of urinary incontinence after endoscopic bipolar transurethral prostatectomy

Brief summary: This is a prospective cohort study aiming to identify the preoperative and intraoperative predictors of urinary incontinence after endoscopic transurethral bipolar prostatectomy

Detailed description: Benign prostatic hyperplasia (BPH) represents a progressive, age-related proliferation of prostatic stromal and epithelial cells, with histopathological changes typically manifesting after the fourth decade of life. Epidemiological studies demonstrate a prevalence increasing from approximately 50% in men aged 60 years to 90% by age 85 years. The condition frequently results in bladder outlet obstruction, clinically presenting as lower urinary tract symptoms (LUTS) that are conventionally categorized into obstructive (voiding) and storage (irritative) subtypes. Among contemporary surgical interventions, transurethral bipolar prostatectomy techniques - including bipolar transurethral resection of the prostate (B-TURP) and bipolar laser enucleation of the prostate (BipoLEP) - have established efficacy in the management of BPH-induced LUTS, as demonstrated in randomized controlled trials and meta-analyses.

Postoperative urinary incontinence (UI) remains among the most clinically significant complications following surgical management of benign prostatic hyperplasia (BPH). Early transient UI represents a frequently observed postoperative sequela, serving as both a primary source of patient anxiety regarding surgical intervention and a substantial determinant of postoperative dissatisfaction. While the majority of transient UI cases demonstrate spontaneous resolution within 1-6 months postoperatively, persistent UI develops in a clinically relevant subset of patients. This chronic manifestation constitutes a serious long-term complication which decrease the quality of life of the patients.

Reported rates of urinary incontinence following BPH surgery exhibit considerable variability, which may be attributed to differences in surgical techniques, inconsistent definitions of incontinence, and heterogeneity in assessment methods. Moreover, the majority of studies fail to specify the type or duration of incontinence.

Predictors of postoperative urinary incontinence (UI) following endoscopic surgery for BPH require systematic evaluation to optimize preoperative counseling and identify high-risk patients. A thorough discussion of UI risk should be incorporated into the shared decision-making process. This prospective study aims to identify and characterize preoperative and intraoperative risk factors for stress (SUI) and urge (UUI) urinary incontinence in patients undergoing endoscopic BPH surgeries.

Eligibility criteria: Inclusion Criteria:

* Males ≥50 years undergoing primary B-TURP/BipolEP for BPH
* Preoperative IPSS ≥8, Qmax ≤15 mL/s, prostate volume ≥30mL
* No prior incontinence/neurological bladder dysfunction

Exclusion Criteria:

* Prostate cancer history
* Concurrent anti-incontinence procedures

Primary outcomes:
measure: Preoperative predictors of urinary incontinence
timeFrame: At 6 months after the procedure
Secondary outcomes:
measure: Intraoperative predictors of urinary incontinence
timeFrame: At 6 months after the procedure
Other outcomes:
Locations:
Study officials:
References:
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