- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06939140
Urinary Incontinence After Endoscopic Prostatectomy
Predictors of Urinary Incontinence After Endoscopic Transurethral Bipolar Prostatectomy: a Prospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Assiut, Egypt
- Assiut University Urology Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Endoscopic transurethral bipolar prostatectomy patients
Benign Prostatic Hyperplasia patients who will undergo endoscopic transurethral bipolar prostatectomy
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Endoscopic transurethral bipolar enucleation or reaction of the prostate
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Preoperative predictors of urinary incontinence
Time Frame: At 6 months after the procedure
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Association between patients' preoperative parameters and occurrence of urinary incontinence after the procedure
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At 6 months after the procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative predictors of urinary incontinence
Time Frame: At 6 months after the procedure
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Association between intraoperative parameters and occurrence of urinary incontinence after the procedure
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At 6 months after the procedure
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Pagano E, Laudato M, Griffo M, Capasso R. Phytotherapy of benign prostatic hyperplasia. A minireview. Phytother Res. 2014 Jul;28(7):949-55. doi: 10.1002/ptr.5084.
- Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25.
- Magistro G, Schott M, Keller P, Tamalunas A, Atzler M, Stief CG, Westhofen T. Enucleation vs. Resection: A Matched-pair Analysis of TURP, HoLEP and Bipolar TUEP in Medium-sized Prostates. Urology. 2021 Aug;154:221-226. doi: 10.1016/j.urology.2021.04.004. Epub 2021 Apr 21.
- Matsushita K, Kent MT, Vickers AJ, von Bodman C, Bernstein M, Touijer KA, Coleman JA, Laudone VT, Scardino PT, Eastham JA, Akin O, Sandhu JS. Preoperative predictive model of recovery of urinary continence after radical prostatectomy. BJU Int. 2015 Oct;116(4):577-83. doi: 10.1111/bju.13087. Epub 2015 Mar 30.
- Castellani D, Rubilotta E, Fabiani A, Maggi M, Wroclawski ML, Teoh JY, Pirola GM, Gubbiotti M, Pavia MP, Gomez-Sancha F, Galosi AB, Gauhar V. Correlation Between Transurethral Interventions and Their Influence on Type and Duration of Postoperative Urinary Incontinence: Results from a Systematic Review and Meta-Analysis of Comparative Studies. J Endourol. 2022 Oct;36(10):1331-1347. doi: 10.1089/end.2022.0222. Epub 2022 Jun 13.
- Bauer RM, Gozzi C, Hubner W, Nitti VW, Novara G, Peterson A, Sandhu JS, Stief CG. Contemporary management of postprostatectomy incontinence. Eur Urol. 2011 Jun;59(6):985-96. doi: 10.1016/j.eururo.2011.03.020. Epub 2011 Mar 21.
- Sandhu JS, Breyer B, Comiter C, Eastham JA, Gomez C, Kirages DJ, Kittle C, Lucioni A, Nitti VW, Stoffel JT, Westney OL, Murad MH, McCammon K. Incontinence after Prostate Treatment: AUA/SUFU Guideline. J Urol. 2019 Aug;202(2):369-378. doi: 10.1097/JU.0000000000000314. Epub 2019 Jul 8.
- Huang X, Chen XX, Chen X, Chen QZ, Wang L, Li C, Tian JL. Feasibility of anterior lobe-preserving transurethral enucleation and resection of prostate on improving urinary incontinence in patients with benign prostatic hyperplasia: A retrospective cohort study. Medicine (Baltimore). 2023 Feb 17;102(7):e32884. doi: 10.1097/MD.0000000000032884.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Mental Disorders
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Behavioral Symptoms
- Elimination Disorders
- Urinary Incontinence
- Enuresis
Other Study ID Numbers
- UI after prostatectomy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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