Prostate CancerNCT06543420
The Role of Levator Ani Muscle Reconstruction Technology in Urinary Incontinence Recovery
A study testing lateral reconstruction and posterior reconstruction in people with Prostate Cancer, run by Peking University First Hospital at 1 site in China.
Trial summary
This study is a single center, single blind, prospective randomized controlled trial. Patients undergoing robot assisted laparoscopic radical prostatectomy for prostate cancer were randomly divided into 1:1:1 groups, using lateral reconstruction, posterior reconstruction, or no reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- lateral reconstruction and posterior reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2024to 21 Jul 2026
- 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
- Diagnosed with prostate cancer and preoperative clinical stage of cT2~T3aN0M0
- Complies with the indications for RARP surgery
Who cannot join
- History of urinary incontinence or urethral stricture
- Previous prostate related surgical treatment
- Contraindications for RARP surgery
- The patient or their family members refuse to participate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Kan Gong, (86)-010-83572057, kan.gong@bjmu.edu.cn
About this study
Official title: The Role of Levator Ani Muscle Reconstruction Technology in Urinary Incontinence Recovery After Robot Assisted Radical Prostatectomy: a Randomized Controlled Clinical Trial
This study is a single center, single blind, prospective randomized controlled trial. Patients undergoing robot assisted laparoscopic radical prostatectomy for prostate cancer were randomly divided into 1:1:1 groups, using lateral reconstruction, posterior reconstruction, or no reconstruction. Patients were followed up regularly after surgery and clinical data were collected, including daily use of urine pads, ICIQ-SF score, 24-hour urine leakage, I-QoL score, etc., to evaluate the improvement effect of lateral reconstruction on urinary control and the difference in effect between lateral reconstruction and posterior reconstruction, thereby improving the quality of life of prostate cancer patients after surgery.
Read the detailed description
This study is a single center, single blind, prospective randomized controlled trial. Collect baseline data from enrolled patients Materials were randomly divided into experimental group A (lateral reconstruction group), experimental group B (posterior reconstruction group), and control group (non reconstruction group) in a 1:1:1 ratio using a computer-generated random number sequence.
In the control group (non reconstruction group), no lateral or posterior reconstruction was performed after RARP surgery.
In experimental group A (lateral reconstruction group), lateral reconstruction was performed after RARP surgery, in which the levator ani muscle was sutured to the prostatic collateral ligament and fascia to strengthen the lateral posterior support structure.
In experimental group B (post reconstruction group), post reconstruction was performed after RARP surgery.
This study used blinding on patients to avoid subjective factors affecting the results of whether reconstruction was performed or not.
Preoperative collection of baseline data from patients includes age, BMI, history of abdominal surgery, most recent PSA, PI-RADS score, prostate volume, prostate puncture related data (histological type, number of positive needles/puncture needles, Gleason score, maximum tumor proportion), PSMA PET-CT results, neoadjuvant therapy regimen, International Advisory Committee on Urinary Incontinence Questionnaire Brief (ICIQ-SF) score, International Index of Erectile Function (IIEF-5) score, International Prostate Symptom Score (IPSS) score, etc.
Collect postoperative patient surgical data (including ASA score, surgical duration, intraoperative blood loss, etc.), hospitalization data (including hospitalization duration, hospitalization costs, etc.), and pathological data (including lesion diameter, histological type, Gleason score, pathological staging, positive surgical margin, invasion of capsule, invasion of seminal vesicle and adjacent tissues, etc.).
Follow up visits were conducted on patients at 1, 3, 6, 9, and 12 months postoperatively, and relevant clinical data were collected, including the number of urine pads used per day during follow-up, ICIQ-SF score, 24-hour urine leakage (accurately measured by purchasing an electronic scale for patients), perioperative and postoperative complications, IIEF-5 score, PSA, and urinary incontinence quality of life questionnaire (I-QOL) score, in order to evaluate the improvement effect of lateral reconstruction on urinary control and quality of life, as well as the impact on complication incidence, erectile function, and tumor control. The differences in the effects of lateral reconstruction and posterior reconstruction on urinary control recovery and quality of life improvement were compared.
- Conditions
- Prostate Cancer
- Being tested
- lateral reconstruction, posterior reconstruction
- Keywords
- Prostate cancer, Levator ani muscle reconstruction, Urinary incontinence recovery, Robot-assisted radical prostatectomy, Randomized controlled trial
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral reconstructionProcedure or surgery
In lateral reconstruction group, lateral reconstruction is performed by suturing the levator ani muscle to the prostatic collateral ligament and fascia to strengthen the lateral posterior support structure.
posterior reconstructionProcedure or surgery
In posterior group, prior to completion of the operation, the posterior fibrous tissues of the sphincter are joined to the residual Denonvilliers fascia on the posterior bladder wall 1-2 cm cephalad and dorsally to the new bladder neck.
| Study group | Role | What they receive |
|---|---|---|
| lateral reconstruction group | Experimental | After RARP surgery, lateral reconstruction is performed Receives: Procedure: lateral reconstruction |
| posterior reconstruction group | Experimental | After RARP surgery, posterior reconstruction is performed Receives: Procedure: posterior reconstruction |
| control group | No intervention | No lateral or posterior reconstruction is performed after RARP surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery rate of urinary incontinence
Urinary incontinence recovery is defined as using 0 urinary pads per day
Measured: 1,3,6,9,12 months after operation
Secondary outcomes (5)
The International Consultation on Incontinence Questionnaire Short-form(ICIQ-SF) Score
ICIQ-SF is a questionnaire used to evaluate urinary incontinence and assess the recovery of postoperative urinary incontinence in patients. The range of scores is from 0 to 21, with higher scores indicating more severe urinary incontinence.
Measured: 1,3,6,9,12 months after operation
Incontinence Quality of Life Questionnaire(I-QOL) Score
I-QoL is a questionnaire used to evaluate the quality of life of patients with urinary incontinence after surgery. The range of scores is from 0 to 100, with higher scores indicating higher quality of life.
Measured: 1,3,6,9,12 months after operation
Perioperative and postoperative complications
Collect perioperative and postoperative complications such as bleeding and pain to compare the differences between two reconstruction methods and non reconstruction methods.
Measured: 1,3,6,9,12 months after operation
Prostate-specific antigen
Biochemical recurrence is defined as two consecutive postoperative PSA levels above 0.2 ng/ml with an upward trend
Measured: 1,3,6,9,12 months after operation
Duration of operation
The purpose of collecting surgical duration is to compare whether there are differences between two reconstruction techniques and no reconstruction.
Measured: immediately after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start22 Jul 2024
- Primary completion21 Jul 2025 (estimated)
- Study completion21 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GONG Kan, Peking University First Hospital
- Investigators
- Kan Gong, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543420
- Sponsor's protocol ID
- chfcj2024
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Levator Ani Muscle Reconstruction Technology in Urinary Incontinence Recovery After Robot Assisted Radical Prostatectomy: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06543420
- Acronym / sponsor ID
- chfcj2024
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Levator ani muscle reconstruction, Urinary incontinence recovery, Robot-assisted radical prostatectomy, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 21 Jul 2025 (estimated)
- Study completion
- 21 Jul 2026 (estimated)
- First posted
- 9 Aug 2024 (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 single center, single blind, prospective randomized controlled trial. Patients undergoing robot assisted laparoscopic radical prostatectomy for prostate cancer were randomly divided into 1:1:1 groups, using lateral reconstruction, posterior reconstruction, or no reconstruction. Patients were followed up regularly after surgery and clinical data were collected, including daily use of urine pads, ICIQ-SF score, 24-hour urine leakage, I-QoL score, etc., to evaluate the improvement effect of lateral reconstruction on urinary control and the difference in effect between lateral reconstruction and posterior reconstruction, thereby improving the quality of life of prostate cancer patients after surgery.
Detailed description
This study is a single center, single blind, prospective randomized controlled trial. Collect baseline data from enrolled patients Materials were randomly divided into experimental group A (lateral reconstruction group), experimental group B (posterior reconstruction group), and control group (non reconstruction group) in a 1:1:1 ratio using a computer-generated random number sequence.
In the control group (non reconstruction group), no lateral or posterior reconstruction was performed after RARP surgery.
In experimental group A (lateral reconstruction group), lateral reconstruction was performed after RARP surgery, in which the levator ani muscle was sutured to the prostatic collateral ligament and fascia to strengthen the lateral posterior support structure.
In experimental group B (post reconstruction group), post reconstruction was performed after RARP surgery.
This study used blinding on patients to avoid subjective factors affecting the results of whether reconstruction was performed or not.
Preoperative collection of baseline data from patients includes age, BMI, history of abdominal surgery, most recent PSA, PI-RADS score, prostate volume, prostate puncture related data (histological type, number of positive needles/puncture needles, Gleason score, maximum tumor proportion), PSMA PET-CT results, neoadjuvant therapy regimen, International Advisory Committee on Urinary Incontinence Questionnaire Brief (ICIQ-SF) score, International Index of Erectile Function (IIEF-5) score, International Prostate Symptom Score (IPSS) score, etc.
Collect postoperative patient surgical data (including ASA score, surgical duration, intraoperative blood loss, etc.), hospitalization data (including hospitalization duration, hospitalization costs, etc.), and pathological data (including lesion diameter, histological type, Gleason score, pathological staging, positive surgical margin, invasion of capsule, invasion of seminal vesicle and adjacent tissues, etc.).
Follow up visits were conducted on patients at 1, 3, 6, 9, and 12 months postoperatively, and relevant clinical data were collected, including the number of urine pads used per day during follow-up, ICIQ-SF score, 24-hour urine leakage (accurately measured by purchasing an electronic scale for patients), perioperative and postoperative complications, IIEF-5 score, PSA, and urinary incontinence quality of life questionnaire (I-QOL) score, in order to evaluate the improvement effect of lateral reconstruction on urinary control and quality of life, as well as the impact on complication incidence, erectile function, and tumor control. The differences in the effects of lateral reconstruction and posterior reconstruction on urinary control recovery and quality of life improvement were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lateral reconstruction group | Experimental | Procedure: lateral reconstructionAfter RARP surgery, lateral reconstruction is performed |
| posterior reconstruction group | Experimental | Procedure: posterior reconstructionAfter RARP surgery, posterior reconstruction is performed |
| control group | No intervention | –No lateral or posterior reconstruction is performed after RARP surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with prostate cancer and preoperative clinical stage of cT2~T3aN0M0
- Complies with the indications for RARP surgery
Key exclusion criteria (4 listed)
- History of urinary incontinence or urethral stricture
- Previous prostate related surgical treatment
- Contraindications for RARP surgery
- The patient or their family members refuse to participate
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 |
|---|---|---|
| lateral reconstructionIn lateral reconstruction group, lateral reconstruction is performed by suturing the levator ani muscle to the prostatic collateral ligament and fascia to strengthen the lateral posterior support structure. | Procedure or surgery | lateral reconstruction group |
| posterior reconstructionIn posterior group, prior to completion of the operation, the posterior fibrous tissues of the sphincter are joined to the residual Denonvilliers fascia on the posterior bladder wall 1-2 cm cephalad and dorsally to the new bladder neck. | Procedure or surgery | posterior reconstruction group |
Primary outcome
Recovery rate of urinary incontinence
Time frame: 1,3,6,9,12 months after operation
Urinary incontinence recovery is defined as using 0 urinary pads per day
5 secondary outcomes
The International Consultation on Incontinence Questionnaire Short-form(ICIQ-SF) Score
Time frame: 1,3,6,9,12 months after operation
Incontinence Quality of Life Questionnaire(I-QOL) Score
Time frame: 1,3,6,9,12 months after operation
Perioperative and postoperative complications
Time frame: 1,3,6,9,12 months after operation
Prostate-specific antigen
Time frame: 1,3,6,9,12 months after operation
Duration of operation
Time frame: immediately after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Kan Gong principal investigator
Peking University First 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 lateral reconstruction and posterior reconstruction in people with Prostate Cancer, run by Peking University First 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kan Gong, MD ((86)-010-83572075, kan.gong@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery rate of urinary incontinence (time frame: 1,3,6,9,12 months after operation). 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 9 Aug 2024.