Urinary Incontinence
Conditions
Keywords
Prostate Cancer, Urinary incontinence, Radical prostatectomy, Rhabdosphincter, Robotic Surgery
Brief summary
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.
Interventions
PROCEDURERadical prostatectomy with posterior rhabdosphincter reconstruction
To suture the Denonvilliers fascia and bladder to the median dorsal raphe according to Rocco technique.
PROCEDURERadical prostatectomy without posterior rhabdosphincter reconstruction
Standard technique with a running suture to perform the urethrovesical anastomosis
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Histological confirmation of prostate cancer * Localized or locally advanced prostate cancer * Informed consent signed
Exclusion criteria
* Presence of urinary incontinence prior to the procedure * Previous radiation therapy of the prostate or pelvis * Presence of any prostatic surgery prior to the procedure * Prior medical history of psychiatric diseases or drug addiction * Any condition that contraindicates a radical prostatectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 month after surgery | Absence of urinary incontinence (number of PADs/d) |
| Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 6th month | 6 months after surgery | Absence of urinary incontinence (number of PADs/d) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erectile function | 1, 6 and 12 months | SHIM assessment |
| Quality of life I: urinary and bowel function | 1, 6 and 12 months | EPIC-26 urinary and digestive function |
| Quality of life II: urinary function | 1, 6 and 12 months | ICIQ-SF assessment of urinary function |
| early urinary recovery quantification in Grams (PAD-test 24h) | one day before catheter removal, 2 weeks before and 1 month before | PAD-test during the first month after surgery |
| Oncological outcome: Biochemical free-recurrence status | 1, 6 and 12 months | serum PSA assessment. Biochemical free-recurrence status = PSA \<0.2 |
| Anatomopathological parameters: Surgical margins | 1 month | Surgery margins in prostatectomy specimens |
| Anatomopathological parameters: pTNM classification | 1 month | Pathological pTNM in prostatectomy specimens |
| Quality of life III: urinary function | 1, 6 and 12 months | IPSS assessment of urinary function |
| Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 12th month | 12 months after surgery | Absence of urinary incontinence (number of PADs/d) |
Countries
Spain
Outcome results
None listed