Clinical trial · Interventional
Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling
Randomized Controlled Trial Examining the Return of Urinary Continence After Robot-assisted Radical Prostatectomy With or Without a Urethrovesical Sling
NCT00937833CI-TRIAL-00016465completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine the impact of an absorbable urethrovesical sling on the post-operative return of urinary continence after robot-assisted radical prostatectomy.
Conditions
Conditions (2)
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 |
| Urinary Incontinence | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostatectomy | Procedure | — | UNRESOLVED |
| Surgisis Male Sling | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Urethrovesical Sling
- description
- Surgisis Male Sling placed at the time of prostatectomy
- interventionNames
- Procedure: Prostatectomy
- Device: Surgisis Male Sling
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Prostatectomy
- interventionNames
- Procedure: Prostatectomy
Primary outcomes (1)
- measure
- Number of Continent Patients Post Prostatectomy
- timeFrame
- 1 Month
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have organ confined prostate cancer. * Patients must have PSA\< 15. * Patients must have clinical stage prostate cancer \< cT3. * Patients must be scheduled for robot assisted transperitoneal laparoscopic radical prostatectomy. * Patients must be able to provide written informed consent and HIPAA authorization for release of personal health information. * Patients must be at least 18 years of age. Exclusion Criteria: * Patients must not have previously undergone transurethral resection, laser therapy, microwave therapy, radiofrequency ablation, or other surgery of the prostate. * Patients must not have previously undergone incision of urethral stricture or incision of bladder neck contracture. * Patients must not have previously been diagnosed with urethral stricture, bladder neck contracture or urinary incontinence. * Patients must not have previously been diagnosed with atonic bladder or neurogenic bladder. * Patients must not have significant pre-operative voiding symptoms as defined by an American Urologic Association symptom score of greater than 19. * Patients must not have a prior history of radiation to the pelvis. * Patients must not have persistent bacteriuria that cannot be cleared, as demonstrated by a negative urinalysis or urine culture, within 1 month of surgery. * Patients must not have allergies to pig tissue or pig products or have religious or cultural objection to the use of pig tissue.
References
Publications (0)
Data not yet available
No reference posted for this study.