Prostate Cancer (Post Prostatectomy)NCT06850116
Analysis of Immediate Urinary Continence Predictors After RS-RARP
An observational study of Prostate Cancer (Post Prostatectomy) and Urinary Continence, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
This study is a retrospective, single-center clinical trial. It aims to retrospectively analyze the immediate postoperative urinary continence recovery in prostate cancer patients who underwent Retzius-sparing robot-assisted radical prostatectomy in the investigators' center. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer (Post Prostatectomy), Urinary Continence, Retzius-sparing Robot-assisted Radical Prostatectomy
- What is being tested?
- Retzius-sparing robot-assisted radical prostatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prostate cancer patients underwent RS-RARP.
Who may be able to join
- Prostate cancer diagnosed by prostate biopsy and underwent Retzius-sparing robot-assisted radical prostatectomy in the investigators' hospital.
- Received plain and contrast-enhanced pelvic or prostate MRI examinations before surgery.
- Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 1.
- Complete clinicopathological data.
- In good general condition, without infections, autoimmune diseases, hematological diseases or other malignant tumors.
- Complete postoperative follow-up data, with a postoperative follow-up time of no less than 6 months.
Who cannot join
- The patient has surgical contraindications.
- The patient has contraindications for MRI examination.
- Preoperative presence of congenital urinary system malformations, urinary incontinence or severe lower urinary tract symptoms, and with a history of urinary catheter or previous transurethral resection of the prostate (TURP) surgery.
- Having received neoadjuvant treatments that may affect the results of this study, such as radiotherapy or hormonal therapy.
- The patient has other concurrent malignant tumors.
- The patient has delayed extubation (> 14 days).
- The patient's clinical, imaging and pathological data are incomplete or the patient is lost to follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
first hospital affiliated of Fujian medical university
Fuzhou, Fujian, 350005
About this study
Official title: Analysis of Immediate Urinary Continence Predictors After Retzius-sparing Robot-assisted Radical Prostatectomy: A Single-center Retrospective Clinical Study
This study is a retrospective, single-center clinical trial. It aims to retrospectively analyze the immediate postoperative urinary continence recovery in prostate cancer patients who underwent Retzius-sparing robot-assisted radical prostatectomy in the investigators' center. Based on the general conditions of patients, relevant perioperative clinical indicators, and parameters related to the sphincter and prostate gland measured by MRI, it explores the influencing factors of immediate urinary continence recovery after Retzius-sparing robot-assisted radical prostatectomy in prostate cancer patients and constructs a relevant prediction model, thereby providing clinical guidance value for predicting immediate postoperative urinary continence recovery.
- Conditions
- Prostate Cancer (Post Prostatectomy), Urinary Continence, Retzius-sparing Robot-assisted Radical Prostatectomy
- Being tested
- Retzius-sparing robot-assisted radical prostatectomy
- Keywords
- Retzius-sparing robot-assisted radical prostatectomy, Prostate Cancer, urinary continence
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retzius-sparing robot-assisted radical prostatectomyProcedure or surgery
Retzius-sparing robot-assisted radical prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| The Retzius-sparing robot-assisted radical prostatectomy group | In 2010, Italian urologist Dr Bocciardi carried out the first clinical practice of separation and resection of the prostate via the vesicorectal fossa, and this new surgical procedure was called Retzius-sparing Robotic Assisted Radical Prostatectomy (RS-RARP). In recent years, the posterior approach extrafascial technique of RS-RARP which has been used to widely resect the prostate and its surrounding fascia and neurovascular bundles, compared with RS-RARP, has been proposed to provide more complete resection of the tumour and reduce the rate of positive margins. The patients are included into the Retzius-sparing robot-assisted radical prostatectomy group group who undergo the posterior approach extrafascial technique of RS-RARP. Receives: Procedure: Retzius-sparing robot-assisted radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of continence
Time Frame: 1 week after postoperative removal of the urinary catheter
Measured: rate of the preservation of urinary control function at 1 week after postoperative removal of the urinary catheter status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Post Prostatectomy)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850116
- Sponsor's protocol ID
- MRCTA,ECFAH OfFMUI2025]002
- Status last verified
- Apr 2025
- First submitted
- 24 Feb 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Immediate Urinary Continence Predictors After Retzius-sparing Robot-assisted Radical Prostatectomy: A Single-center Retrospective Clinical Study
- ClinicalTrials.gov ID
- NCT06850116
- Acronym / sponsor ID
- MRCTA,ECFAH OfFMUI2025]002
- Conditions
- Prostate Cancer (Post Prostatectomy), Urinary Continence, Retzius-sparing Robot-assisted Radical Prostatectomy
- Keywords
- Retzius-sparing robot-assisted radical prostatectomy, Prostate Cancer, urinary continence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 27 Feb 2025 (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 study is a retrospective, single-center clinical trial. It aims to retrospectively analyze the immediate postoperative urinary continence recovery in prostate cancer patients who underwent Retzius-sparing robot-assisted radical prostatectomy in the investigators' center. Based on the general conditions of patients, relevant perioperative clinical indicators, and parameters related to the sphincter and prostate gland measured by MRI, it explores the influencing factors of immediate urinary continence recovery after Retzius-sparing robot-assisted radical prostatectomy in prostate cancer patients and constructs a relevant prediction model, thereby providing clinical guidance value for predicting immediate postoperative urinary continence recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Retzius-sparing robot-assisted radical prostatectomy group | – | Procedure: Retzius-sparing robot-assisted radical prostatectomyIn 2010, Italian urologist Dr Bocciardi carried out the first clinical practice of separation and resection of the prostate via the vesicorectal fossa, and this new surgical procedure was called Retzius-sparing Robotic Assisted Radical Prostatectomy (RS-RARP). In recent years, the posterior approach extrafascial technique of RS-RARP which has been used to widely resect the prostate and its surrounding fascia and neurovascular bundles, compared with RS-RARP, has been proposed to provide more complete resection of the tumour and reduce the rate of positive margins. The patients are included into the Retzius-sparing robot-assisted radical prostatectomy group group who undergo the posterior approach extrafascial technique of RS-RARP. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prostate cancer patients underwent RS-RARP.
Key inclusion criteria (6 listed)
- Prostate cancer diagnosed by prostate biopsy and underwent Retzius-sparing robot-assisted radical prostatectomy in the investigators' hospital.
- Received plain and contrast-enhanced pelvic or prostate MRI examinations before surgery.
- Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 1.
- Complete clinicopathological data.
- In good general condition, without infections, autoimmune diseases, hematological diseases or other malignant tumors.
Key exclusion criteria (7 listed)
- The patient has surgical contraindications.
- The patient has contraindications for MRI examination.
- Preoperative presence of congenital urinary system malformations, urinary incontinence or severe lower urinary tract symptoms, and with a history of urinary catheter or previous transurethral resection of the prostate (TURP) surgery.
- Having received neoadjuvant treatments that may affect the results of this study, such as radiotherapy or hormonal therapy.
- The patient has other concurrent malignant tumors.
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 |
|---|---|---|
| Retzius-sparing robot-assisted radical prostatectomyRetzius-sparing robot-assisted radical prostatectomy | Procedure or surgery | The Retzius-sparing robot-assisted radical prostatectomy group |
Primary outcome
rate of continence
Time frame: rate of the preservation of urinary control function at 1 week after postoperative removal of the urinary catheter status
Time Frame: 1 week after postoperative removal of the urinary catheter
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer (Post Prostatectomy) and Urinary Continence, run by First Affiliated Hospital of Fujian Medical University 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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 4 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
rate of continence (time frame: rate of the preservation of urinary control function at 1 week after postoperative removal of the urinary catheter status). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2025.