NCT06939140

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

2.9 years

First QC Date

April 15, 2025

Last Update Submit

July 21, 2025

Conditions

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)

Outcome Measures

Primary Outcomes (1)

  • Preoperative predictors of urinary incontinence

    Association between patients' preoperative parameters and occurrence of urinary incontinence after the procedure

    At 6 months after the procedure

Secondary Outcomes (1)

  • Intraoperative predictors of urinary incontinence

    At 6 months after the procedure

Study Arms (1)

Endoscopic transurethral bipolar prostatectomy patients

Benign Prostatic Hyperplasia patients who will undergo endoscopic transurethral bipolar prostatectomy

Procedure: Bipolar prostatectomy

Interventions

Endoscopic transurethral bipolar enucleation or reaction of the prostate

Endoscopic transurethral bipolar prostatectomy patients

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • Prostate cancer history
  • Concurrent anti-incontinence procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Urology Hospital

Asyut, Egypt

Location

Related Publications (8)

  • 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.

    PMID: 25682782BACKGROUND
  • 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.

    PMID: 35587146BACKGROUND
  • 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.

    PMID: 21458914BACKGROUND
  • 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.

    PMID: 31059663BACKGROUND
  • 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.

    PMID: 36800610BACKGROUND
  • 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.

    PMID: 24972732BACKGROUND
  • 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.

    PMID: 33891930BACKGROUND
  • 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.

    PMID: 25165780BACKGROUND

MeSH Terms

Conditions

Urinary IncontinenceUrinary Incontinence, StressUrinary Incontinence, UrgeProstatic Hyperplasia

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsProstatic DiseasesGenital Diseases, MaleGenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Urology

Study Record Dates

First Submitted

April 15, 2025

First Posted

April 22, 2025

Study Start

July 1, 2022

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be made available to protect privacy of patients

Locations