Robot-assisted surgery for bladder cancer with nerve preservation
Robot-assisted Cystectomy With Prostate and Seminal-sparing Technique Followed by Modified Orthotopic Ileal Neobladder
This study is testing a new robot-assisted surgery for bladder cancer that aims to remove tumors while keeping the prostate and nerves safe to help patients recover better and have fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | Male |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05881642 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a robot-assisted surgical technique for bladder cancer that aims to preserve the prostate and seminal vesicles while ensuring effective tumor control. The approach involves transurethral resection of the prostate to minimize trauma and enhance nerve preservation, potentially improving urinary control and reducing hospitalization time. Patients will be monitored postoperatively for complications and continence levels, with follow-ups scheduled at regular intervals for up to three years. The study compares this innovative method to conventional radical cystoprostatectomy.
Who should consider this trial
Good fit: Ideal candidates are male patients under 70 years old with muscle invasive or recurrent non-muscle invasive bladder cancer and good urethral sphincter function.
Not a fit: Patients with certain types of bladder cancer, renal insufficiency, or severe liver or intestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve sexual function and urinary control for patients undergoing bladder cancer surgery.
How similar studies have performed: While similar approaches have been explored, this specific method of nerve-sparing cystectomy using robotic assistance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Muscle invasive or recurrent multiple non-muscle invasive bladder cancer patients 2. Invasive bladder cancer patients without invasion of the triangle and posterior urethra 3. Age \< 70 years old, urethral sphincter function is good 4. Male patients with serum prostate specific antigen \< 4ug / L Exclusion Criteria: 1. Possible recurrence of urethra after cystectomy 2. Patients with bladder adenocarcinoma and squamous cell carcinoma should not undergo orthotopic neobladder. 3. Patients with renal insufficiency 4. Severe liver dysfunction 5. Severe intestinal diseases ( Crohn 's disease, short bowel syndrome ) 6. Preoperative tumor breaks through the bladder and invades the surrounding tissue 7. urethral stricture cannot pass through the resectoscope
Where this trial is running
Wuhan, Hubei
- Union hospital,Tongji medical college, Huazhong university of science and techonology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Xiaoping Zhang — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study coordinator: Xiaoping Zhang
- Email: xzhang@hust.edu.cn
- Phone: +86-027-85351625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.