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This is a prospective randomized controlled trail to assess early urinary continence recovery rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter reconstruction is performed or not. A hundred forty-six patients with clinically localized and histological confirmed prostate cancer will be enrolled. Continence recovery is defined in the present study as declared urinary continence (absence of incontinence episodes) in the physician interview as no pad use. Continence rates will be explored also by EPIC, ICIQ-SF, IPSS questionnaires 1, 6 and 12 months after the procedure. The sexual function as the secondary objective will be assessed by SHIM questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posterior Rhabdosphincter Reconstruction | Experimental | Patients in who posterior rhabdosphincter reconstruction is performed |
|
| Standard Technique | Active Comparator | Patients in who posterior rhabdosphincter reconstruction is NOT performed, Standard technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radical prostatectomy with posterior rhabdosphincter reconstruction | Procedure | To suture the Denonvilliers fascia and bladder to the median dorsal raphe according to Rocco technique. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 1st monthNumber of patients using 0-1 PAD/d (EPIC-26 question_5) at 1st month | Absence of urinary incontinence (number of PADs/d) | 1 month after surgery |
| Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 6th month | Absence of urinary incontinence (number of PADs/d) | 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| early urinary recovery quantification in Grams (PAD-test 24h) | PAD-test during the first month after surgery | one day before catheter removal, 2 weeks before and 1 month before |
| Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 12th month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Morote, PhD | Hospital Vall d'Hebron | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35272967 | Derived | Salazar A, Regis L, Planas J, Celma A, Trilla E, Morote J. Continence definition and prognostic factors for early urinary continence recovery in posterior rhabdosphincter reconstruction after robot-assisted radical prostatectomy. Post-hoc analysis of a randomised controlled trial. Actas Urol Esp (Engl Ed). 2022 Apr;46(3):159-166. doi: 10.1016/j.acuroe.2021.06.012. Epub 2022 Mar 7. English, Spanish. | |
| 33653674 |
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This is a prospective randomized controlled trial to assess early urinary continence recovery rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter reconstruction is performed or not.
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|
| Radical prostatectomy without posterior rhabdosphincter reconstruction | Procedure | Standard technique with a running suture to perform the urethrovesical anastomosis |
|
Absence of urinary incontinence (number of PADs/d)
| 12 months after surgery |
| Erectile function | SHIM assessment | 1, 6 and 12 months |
| Quality of life I: urinary and bowel function | EPIC-26 urinary and digestive function | 1, 6 and 12 months |
| Quality of life II: urinary function | ICIQ-SF assessment of urinary function | 1, 6 and 12 months |
| Quality of life III: urinary function | IPSS assessment of urinary function | 1, 6 and 12 months |
| Oncological outcome: Biochemical free-recurrence status | serum PSA assessment. Biochemical free-recurrence status = PSA <0.2 | 1, 6 and 12 months |
| Anatomopathological parameters: Surgical margins | Surgery margins in prostatectomy specimens | 1 month |
| Anatomopathological parameters: pTNM classification | Pathological pTNM in prostatectomy specimens | 1 month |
| Derived |
| Salazar A, Regis L, Planas J, Celma A, Santamaria A, Trilla E, Morote J. A Randomised Controlled Trial to Assess the Benefit of Posterior Rhabdosphincter Reconstruction in Early Urinary Continence Recovery after Robot-assisted Radical Prostatectomy. Eur Urol Oncol. 2022 Aug;5(4):460-463. doi: 10.1016/j.euo.2021.02.005. Epub 2021 Feb 27. |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D011469 | Prostatic Diseases |
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| ID | Term |
|---|---|
| D000072229 | Posterior Cruciate Ligament Reconstruction |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D001178 | Arthroplasty |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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