Prostate CancerNCT04037800
An RCT to Compare Early Continence Recovery After RARP With or Without Sustainable Functional Urethral Reconstruction
A study testing SFUR-RARP and Standard RARP in people with Prostate Cancer and Urinary Incontinence, run by Changhai Hospital at 1 site in China.
Trial summary
The study is a prospective randomized controlled trail to compare early urinary continence recovery after robotic-assisted radical prostatectomy with or without sustainable functional urethral reconstruction (SFUR). Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer, Urinary Incontinence
- What is being tested?
- SFUR-RARP and Standard RARP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2019to 28 Sep 2021
- 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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥40, but ≤75 years old；
- Histological confirmed prostate cancer；
- Localized or locally advanced prostate cancer；
- Presence of urinary continence prior to the procedure;
- Informed consent signed;
Who cannot join
- Metastatic prostate cancer confirmed by ECT, PSMA or whole-body MRI;
- Presence of any prostatic surgery(such as transurethral resection, laser therapy, microwave therapy, radiofrequency ablation and so on) prior to the procedure;
- Radiation therapy of the prostate or pelvis prior to the procedure;
- Uncontrolled intercurrent illness that would limit compliance with study requirements;
- Any condition that contraindicates a radical prostatectomy;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Sustainable Functional Urethral Reconstruction on Early Continence Recovery After Robotic-assisted Radical Prostatectomy: a Randomized Controlled Trial
The study is a prospective randomized controlled trail to compare early urinary continence recovery after robotic-assisted radical prostatectomy with or without sustainable functional urethral reconstruction (SFUR).
Read the detailed description
Early urinary incontinence has always been a tricky problem for both patients and urologists, even though over 90% patients can recover 1 year after surgery. Many urologists are trying to modify the surgical technique to resolve this problem. Sustainable functional urethral reconstruction (SFUR) is a novel technique which may improve early urinary continence recovery for both local and locally advanced prostate cancer, and even for those with high volume prostate by providing adequate urethral length with bladder neck tubularization and making sustainable periurethral support with peritoneal flap. The purpose of this study is to verify the impact of this new technique on early recovery of urinary continence, as well as on urinary function and oncological outcomes.
- Conditions
- Prostate Cancer, Urinary Incontinence
- Being tested
- SFUR-RARP, Standard RARP
- Keywords
- Prostate cancer, Prostatectomy, Robotic surgery, Urinary incontinence, Sustainable functional urethral reconstruction
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFUR-RARPProcedure or surgery
Robotic-assisted radical prostatectomy with sustainable functional urethral reconstruction (SFUR)
Standard RARPProcedure or surgery
Robotic-assisted radical prostatectomy with conventional RARP procedures.
| Study group | Role | What they receive |
|---|---|---|
| SFUR-RARP | Experimental | Patients in which RARP with sustainable functional urethral reconstruction (SFUR) is performed. Receives: Procedure: SFUR-RARP |
| Standard RARP | Active comparator | Patients in which standard RARP is performed. Receives: Procedure: Standard RARP |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-month urinary continence recovery rates
Continence defined as daily usage of 0-1 pad with 24-hour pad weights≤50g.
Measured: 1 month after catheter removal
Secondary outcomes (4)
Short-term urinary continence recovery
Two definitions of urinary continence: daily usage of 0-1 pad with 24-hour pad weights gain≤50g, 0 pads per day. Besides, quantification of urine leakage with 24-hour pad weight.
Measured: Within 3 month after catheter removal
Peri and postoperative complications
Clavien-Dindo classification.
Measured: 1-year follow up
Post-operative oncological outcomes
Two assessment methods: positive surgical margin (PSM) rates and 1-year biochemical recurrence-free survival (BFS, defined as two consecutive PSA levels>0.2 ng/mL).
Measured: 1-year follow up
Short-term urinary function and urinary function-related quality of life
International Prostatic Symptom Score(IPSS) and the IPSS quality of life score.
Measured: 1-week, 2-week, 1-month, 3-month after catheter removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start8 Dec 2019
- Primary completion10 Jan 2021
- Study completion28 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinghao Sun, Changhai Hospital
- Investigators
- Yinghao Sun, MD, PHD, Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037800
- Sponsor's protocol ID
- CH-URO2019001
- Status last verified
- May 2022
- First submitted
- 24 Jul 2019
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ficarra V, Novara G, Rosen RC, Artibani W, Carroll PR, Costello A, Menon M, Montorsi F, Patel VR, Stolzenburg JU, Van der Poel H, Wilson TG, Zattoni F, Mottrie A. Systematic review and meta-analysis of studies reporting urinary continence recovery after robot-assisted radical prostatectomy. Eur Urol. 2012 Sep;62(3):405-17. doi: 10.1016/j.eururo.2012.05.045. Epub 2012 Jun 1.
PubMed 22749852Dev HS, Sooriakumaran P, Srivastava A, Tewari AK. Optimizing radical prostatectomy for the early recovery of urinary continence. Nat Rev Urol. 2012 Jan 24;9(4):189-95. doi: 10.1038/nrurol.2012.2.
PubMed 22270136Bessede T, Sooriakumaran P, Takenaka A, Tewari A. Neural supply of the male urethral sphincter: comprehensive anatomical review and implications for continence recovery after radical prostatectomy. World J Urol. 2017 Apr;35(4):549-565. doi: 10.1007/s00345-016-1901-8. Epub 2016 Aug 2.
PubMed 27484205Pavlovich CP, Rocco B, Druskin SC, Davis JW. Urinary continence recovery after radical prostatectomy - anatomical/reconstructive and nerve-sparing techniques to improve outcomes. BJU Int. 2017 Aug;120(2):185-196. doi: 10.1111/bju.13852. Epub 2017 Apr 17.
PubMed 28319318Bianchi L, Turri FM, Larcher A, De Groote R, De Bruyne P, De Coninck V, Goossens M, D'Hondt F, De Naeyer G, Schatteman P, Mottrie A. A Novel Approach for Apical Dissection During Robot-assisted Radical Prostatectomy: The "Collar" Technique. Eur Urol Focus. 2018 Sep;4(5):677-685. doi: 10.1016/j.euf.2018.01.004. Epub 2018 May 7.
PubMed 29402756
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sustainable Functional Urethral Reconstruction on Early Continence Recovery After Robotic-assisted Radical Prostatectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04037800
- Acronym / sponsor ID
- CH-URO2019001
- Conditions
- Prostate Cancer, Urinary Incontinence
- Keywords
- Prostate cancer, Prostatectomy, Robotic surgery, Urinary incontinence, Sustainable functional urethral reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 8 Dec 2019 (actual)
- Primary completion
- 10 Jan 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 30 Jul 2019 (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.
The study is a prospective randomized controlled trail to compare early urinary continence recovery after robotic-assisted radical prostatectomy with or without sustainable functional urethral reconstruction (SFUR).
Detailed description
Early urinary incontinence has always been a tricky problem for both patients and urologists, even though over 90% patients can recover 1 year after surgery. Many urologists are trying to modify the surgical technique to resolve this problem. Sustainable functional urethral reconstruction (SFUR) is a novel technique which may improve early urinary continence recovery for both local and locally advanced prostate cancer, and even for those with high volume prostate by providing adequate urethral length with bladder neck tubularization and making sustainable periurethral support with peritoneal flap. The purpose of this study is to verify the impact of this new technique on early recovery of urinary continence, as well as on urinary function and oncological outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SFUR-RARP | Experimental | Procedure: SFUR-RARPPatients in which RARP with sustainable functional urethral reconstruction (SFUR) is performed. |
| Standard RARP | Active comparator | Procedure: Standard RARPPatients in which standard RARP is performed. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥40, but ≤75 years old；
- Histological confirmed prostate cancer；
- Localized or locally advanced prostate cancer；
- Presence of urinary continence prior to the procedure;
- Informed consent signed;
Key exclusion criteria (5 listed)
- Metastatic prostate cancer confirmed by ECT, PSMA or whole-body MRI;
- Presence of any prostatic surgery(such as transurethral resection, laser therapy, microwave therapy, radiofrequency ablation and so on) prior to the procedure;
- Radiation therapy of the prostate or pelvis prior to the procedure;
- Uncontrolled intercurrent illness that would limit compliance with study requirements;
- 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 |
|---|---|---|
| SFUR-RARPRobotic-assisted radical prostatectomy with sustainable functional urethral reconstruction (SFUR) | Procedure or surgery | SFUR-RARP |
| Standard RARPRobotic-assisted radical prostatectomy with conventional RARP procedures. | Procedure or surgery | Standard RARP |
Primary outcome
1-month urinary continence recovery rates
Time frame: 1 month after catheter removal
Continence defined as daily usage of 0-1 pad with 24-hour pad weights≤50g.
4 secondary outcomes
Short-term urinary continence recovery
Time frame: Within 3 month after catheter removal
Peri and postoperative complications
Time frame: 1-year follow up
Post-operative oncological outcomes
Time frame: 1-year follow up
Short-term urinary function and urinary function-related quality of life
Time frame: 1-week, 2-week, 1-month, 3-month after catheter removal.
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 18 May 2022.
- Background: PubMed 22749852Ficarra V, Novara G, Rosen RC, Artibani W, Carroll PR, Costello A, Menon M, Montorsi F, Patel VR, Stolzenburg JU, Van der Poel H, Wilson TG, Zattoni F, Mottrie A. Systematic review and meta-analysis of studies reporting urinary continence recovery after robot-assisted radical prostatectomy. Eur Urol. 2012 Sep;62(3):405-17. doi: 10.1016/j.eururo.2012.05.045. Epub 2012 Jun 1.
- Background: PubMed 22270136Dev HS, Sooriakumaran P, Srivastava A, Tewari AK. Optimizing radical prostatectomy for the early recovery of urinary continence. Nat Rev Urol. 2012 Jan 24;9(4):189-95. doi: 10.1038/nrurol.2012.2.
- Background: PubMed 27484205Bessede T, Sooriakumaran P, Takenaka A, Tewari A. Neural supply of the male urethral sphincter: comprehensive anatomical review and implications for continence recovery after radical prostatectomy. World J Urol. 2017 Apr;35(4):549-565. doi: 10.1007/s00345-016-1901-8. Epub 2016 Aug 2.
- Background: PubMed 28319318Pavlovich CP, Rocco B, Druskin SC, Davis JW. Urinary continence recovery after radical prostatectomy - anatomical/reconstructive and nerve-sparing techniques to improve outcomes. BJU Int. 2017 Aug;120(2):185-196. doi: 10.1111/bju.13852. Epub 2017 Apr 17.
- Background: PubMed 29402756Bianchi L, Turri FM, Larcher A, De Groote R, De Bruyne P, De Coninck V, Goossens M, D'Hondt F, De Naeyer G, Schatteman P, Mottrie A. A Novel Approach for Apical Dissection During Robot-assisted Radical Prostatectomy: The "Collar" Technique. Eur Urol Focus. 2018 Sep;4(5):677-685. doi: 10.1016/j.euf.2018.01.004. Epub 2018 May 7.
- 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.
Yinghao Sun, MD, PHD study chair
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SFUR-RARP and Standard RARP in people with Prostate Cancer and Urinary Incontinence, run by Changhai Hospital at 1 site in China.
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 5 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 18 May 2022. 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 China. 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?
1-month urinary continence recovery rates (time frame: 1 month after catheter removal). 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 NCT04037800, which also lists 5 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 18 May 2022.