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Urinary Incontinence (UI)NCT06939140

Urinary Incontinence After Endoscopic Prostatectomy

An observational study of Urinary Incontinence (UI), run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 50 years and older, men only
Conditions the study is for
Urinary Incontinence (UI)
What is being tested?
Bipolar prostatectomy
Type of treatment
Surgery or procedure
How many people
133 participants
Where
1 siteEgypt
Study dates
1 Jul 2022to 1 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • Prostate cancer history
  • Concurrent anti-incontinence procedures

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut University Urology Hospital

    Asyut

Other trials in Egypt

About this study

Official title: Predictors of Urinary Incontinence After Endoscopic Transurethral Bipolar Prostatectomy: a Prospective Cohort Study

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

Read the 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.

Being tested
Bipolar prostatectomy
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)
Medical subject headings
Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence, Urge, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bipolar prostatectomyProcedure or surgery

    Endoscopic transurethral bipolar enucleation or reaction of the prostate

Study groups in NCT06939140
Study groupRoleWhat they receive
Endoscopic transurethral bipolar prostatectomy patientsBenign Prostatic Hyperplasia patients who will undergo endoscopic transurethral bipolar prostatectomy
Receives: Procedure: Bipolar prostatectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preoperative predictors of urinary incontinence

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

    Measured: At 6 months after the procedure

Secondary outcomes (1)

  1. Intraoperative predictors of urinary incontinence

    Association between intraoperative parameters and occurrence of urinary incontinence after the procedure

    Measured: At 6 months after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2025
  2. Study start1 Jul 2022
  3. Primary completion1 Jun 2025
  4. Study completion1 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06939140
Sponsor's protocol ID
UI after prostatectomy
Status last verified
Jul 2025
First submitted
15 Apr 2025
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be made available to protect privacy of patients

Publications

  • 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.

    PubMed 25682782

  • 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.

    PubMed 35587146

  • 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.

    PubMed 21458914

  • 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.

    PubMed 31059663

  • 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.

    PubMed 36800610

  • 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.

    PubMed 24972732

  • 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.

    PubMed 33891930

  • 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.

    PubMed 25165780

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Incontinence (UI), run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preoperative predictors of urinary incontinence (time frame: At 6 months after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06939140, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.

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