Urinary IncontinenceRHABDO-PROSTNCT03302169
Trial to Compare Urinary Continence Recovery After Robotic Radical Prostatectomy With or Without Rhabdosphincter Reconstruction.
A study testing Radical prostatectomy with posterior rhabdosphincter reconstruction and Radical prostatectomy without posterior rhabdosphincter reconstruction in people with Urinary Incontinence, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Radical prostatectomy with posterior rhabdosphincter reconstruction and Radical prostatectomy without posterior rhabdosphincter reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2017to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of prostate cancer
- Localized or locally advanced prostate cancer
- Informed consent signed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Trial to Compare Early Urinary Continence Recovery After Robotic Assisted Radical Prostatectomy With or Without Posterior Rhabdosphincter Reconstruction.
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.
- Conditions
- Urinary Incontinence
- Being tested
- Radical prostatectomy with posterior rhabdosphincter reconstruction, Radical prostatectomy without posterior rhabdosphincter reconstruction
- Keywords
- Prostate Cancer, Urinary incontinence, Radical prostatectomy, Rhabdosphincter, Robotic Surgery
- Medical subject headings
- Urinary Incontinence, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical prostatectomy with posterior rhabdosphincter reconstructionProcedure or surgery
Also called Rocco reconstruction technique, Posterior reconstruction, Rocco Stitch
To suture the Denonvilliers fascia and bladder to the median dorsal raphe according to Rocco technique.
Radical prostatectomy without posterior rhabdosphincter reconstructionProcedure or surgery
Standard technique with a running suture to perform the urethrovesical anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Posterior Rhabdosphincter Reconstruction | Experimental | Patients in who posterior rhabdosphincter reconstruction is performed Receives: Procedure: Radical prostatectomy with posterior rhabdosphincter reconstruction |
| Standard Technique | Active comparator | Patients in who posterior rhabdosphincter reconstruction is NOT performed, Standard technique. Receives: Procedure: Radical prostatectomy without posterior rhabdosphincter reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 6 months after surgery
Secondary outcomes (9)
early urinary recovery quantification in Grams (PAD-test 24h)
PAD-test during the first month after surgery
Measured: 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
Absence of urinary incontinence (number of PADs/d)
Measured: 12 months after surgery
Erectile function
SHIM assessment
Measured: 1, 6 and 12 months
Quality of life I: urinary and bowel function
EPIC-26 urinary and digestive function
Measured: 1, 6 and 12 months
Quality of life II: urinary function
ICIQ-SF assessment of urinary function
Measured: 1, 6 and 12 months
Quality of life III: urinary function
IPSS assessment of urinary function
Measured: 1, 6 and 12 months
Oncological outcome: Biochemical free-recurrence status
serum PSA assessment. Biochemical free-recurrence status = PSA <0.2
Measured: 1, 6 and 12 months
Anatomopathological parameters: Surgical margins
Surgery margins in prostatectomy specimens
Measured: 1 month
Anatomopathological parameters: pTNM classification
Pathological pTNM in prostatectomy specimens
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start1 Jan 2017
- Primary completion1 Nov 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Morote, PhD, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302169
- Sponsor's protocol ID
- PR(AG)330/2016
- Acronym
- RHABDO-PROST
- Status last verified
- Oct 2020
- First submitted
- 15 Aug 2017
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35272967Salazar 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.
PubMed 33653674
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial to Compare Early Urinary Continence Recovery After Robotic Assisted Radical Prostatectomy With or Without Posterior Rhabdosphincter Reconstruction.
- ClinicalTrials.gov ID
- NCT03302169
- Acronym / sponsor ID
- RHABDO-PROST / PR(AG)330/2016
- Conditions
- Urinary Incontinence
- Keywords
- Prostate Cancer, Urinary incontinence, Radical prostatectomy, Rhabdosphincter, Robotic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 5 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Posterior Rhabdosphincter Reconstruction | Experimental | Procedure: Radical prostatectomy with posterior rhabdosphincter reconstructionPatients in who posterior rhabdosphincter reconstruction is performed |
| Standard Technique | Active comparator | Procedure: Radical prostatectomy without posterior rhabdosphincter reconstructionPatients in who posterior rhabdosphincter reconstruction is NOT performed, Standard technique. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histological confirmation of prostate cancer
- Localized or locally advanced prostate cancer
- Informed consent signed
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical prostatectomy with posterior rhabdosphincter reconstructionAlso: Rocco reconstruction technique, Posterior reconstruction, Rocco StitchTo suture the Denonvilliers fascia and bladder to the median dorsal raphe according to Rocco technique. | Procedure or surgery | Posterior Rhabdosphincter Reconstruction |
| Radical prostatectomy without posterior rhabdosphincter reconstructionStandard technique with a running suture to perform the urethrovesical anastomosis | Procedure or surgery | Standard Technique |
Primary outcome
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
Time frame: 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
Time frame: 6 months after surgery
Absence of urinary incontinence (number of PADs/d)
9 secondary outcomes
early urinary recovery quantification in Grams (PAD-test 24h)
Time frame: 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
Time frame: 12 months after surgery
Erectile function
Time frame: 1, 6 and 12 months
Quality of life I: urinary and bowel function
Time frame: 1, 6 and 12 months
Quality of life II: urinary function
Time frame: 1, 6 and 12 months
Quality of life III: urinary function
Time frame: 1, 6 and 12 months
Oncological outcome: Biochemical free-recurrence status
Time frame: 1, 6 and 12 months
Anatomopathological parameters: Surgical margins
Time frame: 1 month
Anatomopathological parameters: pTNM classification
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Derived from this study: PubMed 35272967Salazar 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.
- Derived from this study: PubMed 33653674Salazar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Morote, PhD principal investigator
Hospital Vall d'Hebron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical prostatectomy with posterior rhabdosphincter reconstruction and Radical prostatectomy without posterior rhabdosphincter reconstruction in people with Urinary Incontinence, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1 month after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03302169, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.