Clinical trial · Interventional
Augmented BLAdder NecK rEconstruction Trial for Improved Urinary Function After Radical Prostatectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Stopped due to COVID-19 pandemic, low priority among initiatives and officially terminated.
Summary
Brief summary (as posted)
The investigators are conducting a prospective, randomized trial to investigate whether patients randomized to receive an augmented bladder neck reconstruction (aBNR) at the time of robotic-assisted laparoscopic prostatectomy experience improved urinary function post-operatively compared to patients who undergo prostatectomy with a standard BNR. An aBNR here consists of the autologous medial umbilical ligament sling as well as a bladder neck intussusception stitch. The standard BNR group will receive the intussusception stitch only.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
| Urinary Incontinence | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Augmented Bladder Neck Reconstruction | Procedure | — | UNRESOLVED |
| Standard Bladder Neck Reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Augmented Bladder Neck Reconstruction
- description
- Augmented Bladder Neck Reconstruction (Sling + Intussusception)
- interventionNames
- Procedure: Augmented Bladder Neck Reconstruction
- type
- ACTIVE_COMPARATOR
- label
- Standard Bladder Neck Reconstruction
- description
- Standard Bladder Neck Reconstruction (Intussusception Only)
- interventionNames
- Procedure: Standard Bladder Neck Reconstruction
Primary outcomes (1)
- measure
- EPIC Urinary Incontinence subscale score
- timeFrame
- 1 Month
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Men aged 40 to 70 years of age with localized prostate cancer (clinical stage T2c or less, Gleason grade 5+5=10 or less without any evidence of distant metastases) * Scheduled to undergo curative robot-assisted radical prostatectomy Exclusion Criteria: * Planned pre-operative or post-operative (within 1 month) androgen therapy * Planned pre-operative or post-operative (within 1 month) radiation therapy * History of spinal trauma or surgery to the brain or spinal cord * Pre-operative history of stress urinary incontinence
References
Publications (0)
Data not yet available