Clinical trial · Interventional
Posterior Urethrovesical Anastomotic Reconstruction in Comparison to Conventional Urethrovesical Anastomosis
Impact of Posterior Urethrovesical Reconstruction on Early Return to Urinary Continence Following Robot-assisted Radical Prostatectomy: a Prospective Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Urinary incontinence post radical prostatectomy is a well-recognized complication regardless of approach, with a potential negative impact on health-related quality of life. Although 12-month continence rates range from 85-95% in the literature, few patients are continent in the early postoperative period. It has been suggested that posterior reconstruction of the Denonvilliers' musculofascial plate, also known as the Rocco stitch, may improve early return to urinary continence, though clinical equipoise remains.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional vesicourethral anastomosis. | Procedure | — | UNRESOLVED |
| Posterior reconstruction urethrovesical anastomosis. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Posterior reconstruction urethrovesical anastomosis.
- description
- The intervention comprised of a 2-stitch approximation of the free edge of the Denonvilliers' fascia and posterior bladder wall cranially, to the posterior aspect of the rhabdosphincter and the posterior median raphe caudally, respectively, following prostate extraction. The aim of this approach is to ultimately restore the length of the urethrosphincteric complex, prevent its caudal retraction, and avoid undue tension on the subsequent vesicourethral anastomosis, and provide a posterior support to the urethral sphincter complex to facilitate its effective contraction.
- interventionNames
- Procedure: Posterior reconstruction urethrovesical anastomosis.
- type
- ACTIVE_COMPARATOR
- label
- Conventional urethrovesical anastomosis.
- description
- The conventional is fashioned with a continuous running technique that uses two sutures. The first suture is passed in a clockwise hemicircumferential manner, starting from outside in on the bladder neck at the 5 o'clock position and inside out on the urethra up toward the 12 o'clock position. The second suture is similarly run in a counter- clockwise hemicircumferential direction. The running sutures are snug down after each apposition to ensure there is no slack, and finally tied together with several knots at the 12 o'clock position.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any patient over age 18 (with the ability to give informed consent) with localized prostate cancer (cT1-2, N0, M0). Exclusion Criteria: * History of previous prostatic and/or urethral surgery * A known history of a disease or comorbidity that could affect continence, such as insulin-dependent diabetes or urethral stenosis * Presence of a urinary catheter preventing preoperative evaluation of continence.
References
Publications (0)
Data not yet available