Posterior Bladder Wall ReconstructionNCT06754488
A Technique Improves Urinary Continence in Patients Undergoing Laparoscopic Radical Prostatectomy
A study testing Posterior Reconstruction and anterior suspension in people with Posterior Bladder Wall Reconstruction and Anterior Bladder Wall Reconstruction, run by Suzhou Municipal Hospital at 1 site in China.
Trial summary
Laparoscopic radical prostatectomy (LRP) is the main treatment method for early prostate cancer, and postoperative urinary incontinence is one of the main complications after LRP. Read more about this study
- Who is it for?
- Ages Up to 79 years, men only
- Conditions the study is for
- Posterior Bladder Wall Reconstruction, Anterior Bladder Wall Reconstruction, Anterior Bladder Wall Suspension
- What is being tested?
- Posterior Reconstruction and anterior suspension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Dec 2026
- Phase
- Interventional
- 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 Up to 79 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preoperative needle biopsy confirmed prostate cancer; (2) The clinical stage is T1 and T2
Who cannot join
- Diseases that significantly increase the risk of surgery or anesthesia, such as severe cardiovascular diseases, respiratory diseases, and coagulation disorders. (2) Patients with extensive bone metastasis or metastases to other organs (3) patients with a history of urinary incontinence and transurethral resection of the prostate. (4) Tumor invasion of bladder neck.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215000
About this study
Official title: A New Vesicocervical Urethral Reconstruction Technique Improves Urinary Continence in Patients After Laparoscopic Radical Prostatectomy: a Single-center Randomized Controlled Trial
Laparoscopic radical prostatectomy (LRP) is the main treatment method for early prostate cancer, and postoperative urinary incontinence is one of the main complications after LRP. Urologists have applied various new operations in clinical practice to improve the urinary incontinence of patients after LRP surgery, but urinary incontinence is still the main problem affecting the quality of life of patients after surgery. In recent years, we have found that the new bladder neck urethral reconstruction method adopted by our department in LRP surgery can effectively improve the postoperative urinary incontinence of patients. In this study, a randomized controlled trial was intended to verify that the new bladder and neck urethral reconstruction technique could effectively improve early urinary control in patients after radical laparoscopic prostatectomy, and the patients were randomly divided into four groups by factorial design: posterior reconstruction group, posterior reconstruction +anterior suspension group, Sham group, and anterior suspension group to further verify the influencing factors of improved urinary control. The aim is to prove that the new operation can effectively reduce the urinary incontinence rate of patients after LRP, and analyze the mechanism of the new operation to improve the urinary incontinence of patients after LRP, and provide a new idea for the reconstruction of bladder neck and urethra during laparoscopic radical prostatectomy.
Read the detailed description
Prostate cancer is a highly prevalent malignant tumor among men, ranking second in male malignant tumors. Radical prostatectomy (RP) is a primary treatment option for localized prostate cancer, with laparoscopic radical prostatectomy (LRP) being the most commonly used surgical method.
Currently, the evaluation of prostate surgery's effectiveness has expanded beyond merely improving patients' overall survival rates. Both doctors and patients now also prioritize the recovery of postoperative functions. Patel et al. proposed five consecutive criteria for evaluating RP outcomes:Long-term tumor control,Retention of urinary control function,Retention of erectile function,No surgical complications,Negative incisal margin.Urinary incontinence is a significant complication post-RP that severely impacts the quality of life and the willingness of patients to undergo RP. Thus, clinicians continuously improve surgical techniques to enhance urinary control post-RP.
Research indicates that retaining and reconstructing urinary control-related structures can influence postoperative urinary control. Despite various techniques being employed, there is no definitive evidence on the best method for postoperative urinary control. Current techniques to improve postoperative urinary incontinence include:Intraoperative retention of membranous urethra length (MUL),Retention of bladder neck,Retention of neurovascular bundle (NVB),Reconstruction of bladder neck.The internal urethral sphincter, located at the bladder neck, coordinates and controls urination. A study by Nyarangi-Dix et al. showed that preserving the bladder neck opening significantly improves urinary control post-LRP, with urinary control rates of 84.2%, 89.5%, and 94.7% at 3, 6, and 12 months, respectively. These rates were higher compared to those without bladder neck preservation, at 55.3%, 74.8%, and 81.4%.
The impact of NVB retention on urinary control remains controversial, but it may increase the positive resection margin rate. The external urethral sphincter also plays a crucial role in postoperative urine control.Some scholars found that maximizing the preservation of the membranous urethra during surgery improved urinary control rates at 30 days and 1 year post-surgery, reduced the use of urinary pads, and enhanced patients' quality of life.Various scholars have employed different reconstruction techniques to improve postoperative urinary control. For instance, ROCCO et al. used a posterior urethral fascia reconstruction technique, continuously suturing the severed ends of the anterior layer of Denonvilliers' fascia, the posterior bladder wall, the posterior wall of the external urethral sphincter, and the fibrous structure below the external urethral sphincter before vesical-urethral anastomosis. This technique restores the external urethral sphincter to its original anatomic position and reduces vesicourethral anastomosis tension.
The anterior suspension technique, first proposed by Walsh and later applied in LRP by Patel et al., involves suturing the dorsal vein complex (DVC) to the periosteum of the pubic arch to enhance anterior urethral wall support and restore elastic suspension. The Hood technique, another commonly used method, requires freeing the fat layer on the anterior bladder wall's surface to establish the surgical space without fully exposing the retropubic Retzius space. This preserves the suspension support structures around the retropubic urethra, ensuring its integrity.In China, Liu Zhibin et al. used anterior wall reconstruction and posterior wall strengthening techniques for bladder neck and urethra reconstruction to improve postoperative urine control.
These advancements in surgical techniques demonstrate the continuous effort to enhance the quality of life for prostate cancer patients undergoing radical prostatectomy by improving postoperative urinary control.
Even with the numerous surgical techniques available to improve postoperative urinary control for LRP patients, postoperative urinary incontinence remains a significant issue for many. In recent years, our center has adopted a novel bladder neck and urethra reconstruction method during laparoscopic radical prostatectomy for prostate cancer. We utilize the "inverted tennis racket" technique to reconstruct the bladder neck, which lengthens the posterior bladder wall, followed by vesicourethral anastomosis. Post-anastomosis, this is positioned at the upper margin of the symphysis pubis. The anterior bladder wall is then secured behind the symphysis pubis using a continuous 3-0 barb suture. This method has yielded improved results, significantly reducing the rate of postoperative urinary incontinence.
Prostate cancer patients admitted to the Department of Urology at Suzhou Hospital, affiliated with Nanjing Medical University, post-January 2025, were selected for the study. Eligible prostate cancer patients were randomly divided into four groups:1.Posterior wall reconstruction group,2.Posterior wall reconstruction + suspension group.3.Sham group.4.Anterior suspension group All four groups underwent laparoscopic radical prostatectomy via an extraperitoneal approach. During the bladder neck urethral reconstruction step, the experimental groups received the new bladder neck urethral reconstruction, while the control groups underwent conventional surgery. Patients were followed up post-surgery, comparing the urinary control status of both groups immediately after catheter removal and at 1 month, 3 months, 6 months, and 12 months post-surgery.
Inclusion Criteria:1.Age < 80 years old.2.Preoperative biopsy confirming prostate cancer.3.Clinical stages T1 and T2
Exclusion Criteria:
1.Diseases significantly increasing the risk of surgery or anesthesia (e.g., severe cardiovascular disease, respiratory disease, clotting disorders).2.Extensive bone or other organ metastases.3.History of urinary incontinence or transurethral resection of the prostate.4.Tumor invasion
Surgical Procedure for the Posterior Reconstruction Group:
(1)Establish the extraperitoneal space and place the Trocar.(2)Separate the Retzius space, incise the pelvic fascia on both sides of the prostate, sever the bilateral puboprostatic ligaments, and suture the dorsal vein complex (DVC) with 2-0 barb wire.(3)Treat the bladder neck: cut the anterior bladder neck wall sharply with an ultrasonic knife at the prostate-bladder neck junction (12 o'clock), revealing the posterior bladder neck wall. Separate the posterior bladder neck wall on both sides along the level between the bladder neck and prostate using an ultrasonic knife.Separate the prostate and seminal vesicles: find both vas deferens behind the bladder and cut them off, free both seminal vesicles, expose and cut off the lateral ligaments of the prostate with Hem-o-Lok. Open the Denonvilliers fascia and bluntly sharpen the prostatic gland to the apex.Cut off the prostate tip and urethra: cut the DVC with an ultrasonic knife, fully free the urethra at the prostate tip, preserving as much functional urethra length as possible. Cut the urethra with scissors, completely remove the prostate, and place it in a specimen bag without removing it from the body.Perform bladder neck reconstruction and bladder neck urethral anastomosis: reconstruct the bladder neck using the "inverted tennis racket" method to narrow the bladder neck opening and lengthen the posterior bladder wall. Measure the length of the extended part. Suture the bladder and urethra with a 2-0 sliding line from 5 o'clock, with a total of 8-10 stitches.This innovative method aims to improve postoperative urinary control and enhance the quality of life for patients undergoing laparoscopic radical prostatectomy.
Posterior Reconstruction + Anterior Suspension Group: Laparoscopic radical prostatectomy with an extraperitoneal approach (steps 1 to 5) was performed similarly to the posterior wall reconstruction group.(6) The bladder neck was reconstructed using the "inverted tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra.(7)the anterior wall of the bladder was continuously sutured and fixed onto the muscular membrane of the lower margin of the symphysis pubis using a barb suture.
Sham Group: Laparoscopic radical prostatectomy with an extraperitoneal approach (steps 1 to 5) was performed similarly to the posterior wall reconstruction group.(6) The bladder neck was reconstructed using the "tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra.
Anterior Suspension Group: Laparoscopic radical prostatectomy with an extraperitoneal approach (steps 1 to 5) was performed similarly to the posterior wall reconstruction group.(6) The bladder neck was reconstructed using the "tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra.(7)the anterior wall of the bladder was continuously sutured and fixed onto the muscular membrane of the lower margin of the symphysis pubis using a barb suture.
Assessment Methods for Urinary Incontinence: The primary assessment methods include the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), daily urine pad usage, and 24-hour pad weight measurement. Post radical prostatectomy, the standard for urine control is achieved by either not using any urine pads or experiencing no urine leakage daily or by using only one safety urine pad. The ICIQ-SF and the 24-hour pad test were used to objectively evaluate urinary incontinence immediately after Foley catheter removal. Assessments were repeated at 1, 3, 6, and 12 months post-surgery.
- Conditions
- Posterior Bladder Wall Reconstruction, Anterior Bladder Wall Reconstruction, Anterior Bladder Wall Suspension
- Being tested
- Posterior Reconstruction, anterior suspension
- Keywords
- prostate cancer, early urinary continence, laparoscopic radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior ReconstructionProcedure or surgery
Reconstruct the bladder neck using the "inverted tennis racket" method to narrow the bladder neck opening and lengthen the posterior bladder wall. Measure the length of the extended part.
anterior suspensionProcedure or surgery
The anterior wall of the bladder was continuously sutured and fixed onto the muscular membrane of the lower margin of the symphysis pubis using a 3-0 barb suture.
| Study group | Role | What they receive |
|---|---|---|
| posterior reconstruction group | Experimental | In the posterior wall reconstruction group, laparoscopic radical prostatectomy was performed using an extraperitoneal approach:(1)The extraperitoneal space was established, and Trocar was placed.(2)The Retzius space was separated, the pelvic fascia on both sides of the prostate was incised, the bilateral puboprostatic ligaments were severed, and the dorsal vein complex (DVC) was sutured with 2-0 barb wire.(3)The bladder neck was severed.(4)The prostate and seminal vesicles were separated, the Denonvilliers fascia was opened, and the prostate gland was bluntly and sharply separated from the apex. The lateral prostatic ligaments were severed on both sides.(5)The prostate tip and urethra were severed.(6)Bladder neck reconstruction and bladder neck urethral anastomosis were performed: The bladder neck was reconstructed using the "inverted tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra. Receives: Procedure: Posterior Reconstruction |
| posterior reconstruction + anterior suspension group | Experimental | In the posterior reconstruction + anterior suspension group, laparoscopic radical prostatectomy with an extraperitoneal approach (steps 1 to 5) was performed similarly to the posterior wall reconstruction group.(6) The bladder neck was reconstructed using the "inverted tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra.(7)the anterior wall of the bladder was continuously sutured and fixed onto the muscular membrane of the lower margin of the symphysis pubis using a barb suture. Receives: Procedure: Posterior Reconstruction; Procedure: anterior suspension |
| Sham group | No intervention | In the posterior reconstruction + anterior suspension group, laparoscopic radical prostatectomy with an extraperitoneal approach (steps 1 to 5) was performed similarly to the posterior wall reconstruction group.(6) The bladder neck was reconstructed using the "tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra. |
| anterior suspension group | Experimental | In the posterior reconstruction + anterior suspension group, laparoscopic radical prostatectomy with an extraperitoneal approach (steps 1 to 5) was performed similarly to the posterior wall reconstruction group.(6) The bladder neck was reconstructed using the "tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra.(7)the anterior wall of the bladder was continuously sutured and fixed onto the muscular membrane of the lower margin of the symphysis pubis using a barb suture. Receives: Procedure: anterior suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of continence
Continence was defined as no more than 1 pads requirement daily by patients for normal physical activity and incontinence was defined as >1 pads daily.
Measured: 1 month, 3 months, 6 months and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Posterior Bladder Wall ReconstructionStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754488
- Sponsor's protocol ID
- K2024135K01
- Status last verified
- Jun 2024
- First submitted
- 23 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sutherland DE, Linder B, Guzman AM, Hong M, Frazier HA 2nd, Engel JD, Bianco FJ Jr. Posterior rhabdosphincter reconstruction during robotic assisted radical prostatectomy: results from a phase II randomized clinical trial. J Urol. 2011 Apr;185(4):1262-7. doi: 10.1016/j.juro.2010.11.085. Epub 2011 Feb 22.
PubMed 21334025Soda T, Otsuka H, Koike S, Okada T. Baseline factors and surgical procedures affecting changes in lower urinary tract symptoms after robot-assisted radical prostatectomy: the impact of nerve-sparing. Int Urol Nephrol. 2024 Mar;56(3):989-997. doi: 10.1007/s11255-023-03859-9. Epub 2023 Oct 31.
PubMed 37907707Zhao X, Li K, Zhuang R, Liu H, He W, Dong W, Huang H, Huang J, Lin T. Comparison in Efficacy of Periurethral Reconstruction Leading to Urinary Continence Improvement After Robot-assisted Radical Prostatectomy. Ann Surg Oncol. 2024 Dec;31(13):8978-8985. doi: 10.1245/s10434-024-16225-5. Epub 2024 Sep 17.
PubMed 39287903Ortner G, Honis HR, Bohm J, Konschake M, Tokas T, Nagele U. Improved early continence following laparoscopic radical prostatectomy: the urethral hammock technique. World J Urol. 2024 Mar 16;42(1):168. doi: 10.1007/s00345-024-04857-x.
PubMed 38492077Sakai I, Harada K, Hara I, Eto H, Miyake H. Intussusception of the bladder neck does not promote early restoration to urinary continence after non-nerve-sparing radical retropubic prostatectomy. Int J Urol. 2005 Mar;12(3):275-9. doi: 10.1111/j.1442-2042.2005.01070.x.
PubMed 15828955Rocco F, Carmignani L, Acquati P, Gadda F, Dell'Orto P, Rocco B, Bozzini G, Gazzano G, Morabito A. Restoration of posterior aspect of rhabdosphincter shortens continence time after radical retropubic prostatectomy. J Urol. 2006 Jun;175(6):2201-6. doi: 10.1016/S0022-5347(06)00262-X.
PubMed 16697841Catarin MV, Manzano GM, Nobrega JA, Almeida FG, Srougi M, Bruschini H. The role of membranous urethral afferent autonomic innervation in the continence mechanism after nerve sparing radical prostatectomy: a clinical and prospective study. J Urol. 2008 Dec;180(6):2527-31. doi: 10.1016/j.juro.2008.08.020. Epub 2008 Oct 19.
PubMed 18930493Walz J, Burnett AL, Costello AJ, Eastham JA, Graefen M, Guillonneau B, Menon M, Montorsi F, Myers RP, Rocco B, Villers A. A critical analysis of the current knowledge of surgical anatomy related to optimization of cancer control and preservation of continence and erection in candidates for radical prostatectomy. Eur Urol. 2010 Feb;57(2):179-92. doi: 10.1016/j.eururo.2009.11.009. Epub 2009 Nov 11.
PubMed 19931974Harris MJ. The anatomic radical perineal prostatectomy: an outcomes-based evolution. Eur Urol. 2007 Jul;52(1):81-8. doi: 10.1016/j.eururo.2006.10.041. Epub 2006 Oct 30.
PubMed 17084506Walsh PC. Anatomic radical prostatectomy: evolution of the surgical technique. J Urol. 1998 Dec;160(6 Pt 2):2418-24. doi: 10.1097/00005392-199812020-00010.
PubMed 9817395Patel VR, Coelho RF, Palmer KJ, Rocco B. Periurethral suspension stitch during robot-assisted laparoscopic radical prostatectomy: description of the technique and continence outcomes. Eur Urol. 2009 Sep;56(3):472-8. doi: 10.1016/j.eururo.2009.06.007. Epub 2009 Jun 16.
PubMed 19560260Vis AN, van der Poel HG, Ruiter AEC, Hu JC, Tewari AK, Rocco B, Patel VR, Razdan S, Nieuwenhuijzen JA. Posterior, Anterior, and Periurethral Surgical Reconstruction of Urinary Continence Mechanisms in Robot-assisted Radical Prostatectomy: A Description and Video Compilation of Commonly Performed Surgical Techniques. Eur Urol. 2019 Dec;76(6):814-822. doi: 10.1016/j.eururo.2018.11.035. Epub 2018 Dec 2.
PubMed 30514568Walz J, Epstein JI, Ganzer R, Graefen M, Guazzoni G, Kaouk J, Menon M, Mottrie A, Myers RP, Patel V, Tewari A, Villers A, Artibani W. A Critical Analysis of the Current Knowledge of Surgical Anatomy of the Prostate Related to Optimisation of Cancer Control and Preservation of Continence and Erection in Candidates for Radical Prostatectomy: An Update. Eur Urol. 2016 Aug;70(2):301-11. doi: 10.1016/j.eururo.2016.01.026. Epub 2016 Feb 2.
PubMed 26850969Rocco B, Gregori A, Stener S, Santoro L, Bozzola A, Galli S, Knez R, Scieri F, Scaburri A, Gaboardi F. Posterior reconstruction of the rhabdosphincter allows a rapid recovery of continence after transperitoneal videolaparoscopic radical prostatectomy. Eur Urol. 2007 Apr;51(4):996-1003. doi: 10.1016/j.eururo.2006.10.014. Epub 2006 Oct 23.
PubMed 17079070Rocco B, Cozzi G, Spinelli MG, Coelho RF, Patel VR, Tewari A, Wiklund P, Graefen M, Mottrie A, Gaboardi F, Gill IS, Montorsi F, Artibani W, Rocco F. Posterior musculofascial reconstruction after radical prostatectomy: a systematic review of the literature. Eur Urol. 2012 Nov;62(5):779-90. doi: 10.1016/j.eururo.2012.05.041. Epub 2012 May 30.
PubMed 22664219
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Vesicocervical Urethral Reconstruction Technique Improves Urinary Continence in Patients After Laparoscopic Radical Prostatectomy: a Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06754488
- Acronym / sponsor ID
- K2024135K01
- Conditions
- Posterior Bladder Wall Reconstruction, Anterior Bladder Wall Reconstruction, Anterior Bladder Wall Suspension
- Keywords
- prostate cancer, early urinary continence, laparoscopic radical prostatectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Suzhou Municipal HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 31 Dec 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.
Laparoscopic radical prostatectomy (LRP) is the main treatment method for early prostate cancer, and postoperative urinary incontinence is one of the main complications after LRP. Urologists have applied various new operations in clinical practice to improve the urinary incontinence of patients after LRP surgery, but urinary incontinence is still the main problem affecting the quality of life of patients after surgery. In recent years, we have found that the new bladder neck urethral reconstruction method adopted by our department in LRP surgery can effectively improve the postoperative urinary incontinence of patients. In this study, a randomized controlled trial was intended to verify that the new bladder and neck urethral reconstruction technique could effectively improve early urinary control in patients after radical laparoscopic prostatectomy, and the patients were randomly divided into four groups by factorial design: posterior reconstruction group, posterior reconstruction +anterior suspension group, Sham group, and anterior suspension group to further verify the influencing factors of improved urinary control. The aim is to prove that the new operation can effectively reduce the urinary incontinence rate of patients after LRP, and analyze the mechanism of the new operation to improve the urinary incontinence of patients after LRP, and provide a new idea for the reconstruction of bladder neck and urethra during laparoscopic radical prostatectomy.
Detailed description
Prostate cancer is a highly prevalent malignant tumor among men, ranking second in male malignant tumors. Radical prostatectomy (RP) is a primary treatment option for localized prostate cancer, with laparoscopic radical prostatectomy (LRP) being the most commonly used surgical method.
Currently, the evaluation of prostate surgery's effectiveness has expanded beyond merely improving patients' overall survival rates. Both doctors and patients now also prioritize the recovery of postoperative functions. Patel et al. proposed five consecutive criteria for evaluating RP outcomes:Long-term tumor control,Retention of urinary control function,Retention of erectile function,No surgical complications,Negative incisal margin.Urinary incontinence is a significant complication post-RP that severely impacts the quality of life and the willingness of patients to undergo RP. Thus, clinicians continuously improve surgical techniques to enhance urinary control post-RP.
Research indicates that retaining and reconstructing urinary control-related structures can influence postoperative urinary control. Despite various techniques being employed, there is no definitive evidence on the best method for postoperative urinary control. Current techniques to improve postoperative urinary incontinence include:Intraoperative retention of membranous urethra length (MUL),Retention of bladder neck,Retention of neurovascular bundle (NVB),Reconstruction of bladder neck.The internal urethral sphincter, located at the bladder neck, coordinates and controls urination. A study by Nyarangi-Dix et al. showed that preserving the bladder neck opening significantly improves urinary control post-LRP, with urinary control rates of 84.2%, 89.5%, and 94.7% at 3, 6, and 12 months, respectively. These rates were higher compared to those without bladder neck preservation, at 55.3%, 74.8%, and 81.4%.
The impact of NVB retention on urinary control remains controversial, but it may increase the positive resection margin rate. The external urethral sphincter also plays a crucial role in postoperative urine control.Some scholars found that maximizing the preservation of the membranous urethra during surgery improved urinary control rates at 30 days and 1 year post-surgery, reduced the use of urinary pads, and enhanced patients' quality of life.Various scholars have employed different reconstruction techniques to improve postoperative urinary control. For instance, ROCCO et al. used a posterior urethral fascia reconstruction technique, continuously suturing the severed ends of the anterior layer of Denonvilliers' fascia, the posterior bladder wall, the posterior wall of the external urethral sphincter, and the fibrous structure below the external urethral sphincter before vesical-urethral anastomosis. This technique restores the external urethral sphincter to its original anatomic position and reduces vesicourethral anastomosis tension.
The anterior suspension technique, first proposed by Walsh and later applied in LRP by Patel et al., involves suturing the dorsal vein complex (DVC) to the periosteum of the pubic arch to enhance anterior urethral wall support and restore elastic suspension. The Hood technique, another commonly used method, requires freeing the fat layer on the anterior bladder wall's surface to establish the surgical space without fully exposing the retropubic Retzius space. This preserves the suspension support structures around the retropubic urethra, ensuring its integrity.In China, Liu Zhibin et al. used anterior wall reconstruction and posterior wall strengthening techniques for bladder neck and urethra reconstruction to improve postoperative urine control.
These advancements in surgical techniques demonstrate the continuous effort to enhance the quality of life for prostate cancer patients undergoing radical prostatectomy by improving postoperative urinary control.
Even with the numerous surgical techniques available to improve postoperative urinary control for LRP patients, postoperative urinary incontinence remains a significant issue for many. In recent years, our center has adopted a novel bladder neck and urethra reconstruction method during laparoscopic radical prostatectomy for prostate cancer. We utilize the "inverted tennis racket" technique to reconstruct the bladder neck, which lengthens the posterior bladder wall, followed by vesicourethral anastomosis. Post-anastomosis, this is positioned at the upper margin of the symphysis pubis. The anterior bladder wall is then secured behind the symphysis pubis using a continuous 3-0 barb suture. This method has yielded improved results, significantly reducing the rate of postoperative urinary incontinence.
Prostate cancer patients admitted to the Department of Urology at Suzhou Hospital, affiliated with Nanjing Medical University, post-January 2025, were selected for the study. Eligible prostate cancer patients were randomly divided into four groups:1.Posterior wall reconstruction group,2.Posterior wall reconstruction + suspension group.3.Sham group.4.Anterior suspension group All four groups underwent laparoscopic radical prostatectomy via an extraperitoneal approach. During the bladder neck urethral reconstruction step, the experimental groups received the new bladder neck urethral reconstruction, while the control groups underwent conventional surgery. Patients were followed up post-surgery, comparing the urinary control status of both groups immediately after catheter removal and at 1 month, 3 months, 6 months, and 12 months post-surgery.
Inclusion Criteria:1.Age < 80 years old.2.Preoperative biopsy confirming prostate cancer.3.Clinical stages T1 and T2
Exclusion Criteria:
1.Diseases significantly increasing the risk of surgery or anesthesia (e.g., severe cardiovascular disease, respiratory disease, clotting disorders).2.Extensive bone or other organ metastases.3.History of urinary incontinence or transurethral resection of the prostate.4.Tumor invasion
Surgical Procedure for the Posterior Reconstruction Group:
(1)Establish the extraperitoneal space and place the Trocar.(2)Separate the Retzius space, incise the pelvic fascia on both sides of the prostate, sever the bilateral puboprostatic ligaments, and suture the dorsal vein complex (DVC) with 2-0 barb wire.(3)Treat the bladder neck: cut the anterior bladder neck wall sharply with an ultrasonic knife at the prostate-bladder neck junction (12 o'clock), revealing the posterior bladder neck wall. Separate the posterior bladder neck wall on both sides along the level between the bladder neck and prostate using an ultrasonic knife.Separate the prostate and seminal vesicles: find both vas deferens behind the bladder and cut them off, free both seminal vesicles, expose and cut off the lateral ligaments of the prostate with Hem-o-Lok. Open the Denonvilliers fascia and bluntly sharpen the prostatic gland to the apex.Cut off the prostate tip and urethra: cut the DVC with an ultrasonic knife, fully free the urethra at the prostate tip, preserving as much functional urethra length as possible. Cut the urethra with scissors, completely remove the prostate, and place it in a specimen bag without removing it from the body.Perform bladder neck reconstruction and bladder neck urethral anastomosis: reconstruct the bladder neck using the "inverted tennis racket" method to narrow the bladder neck opening and lengthen the posterior bladder wall. Measure the length of the extended part. Suture the bladder and urethra with a 2-0 sliding line from 5 o'clock, with a total of 8-10 stitches.This innovative method aims to improve postoperative urinary control and enhance the quality of life for patients undergoing laparoscopic radical prostatectomy.
Posterior Reconstruction + Anterior Suspension Group: Laparoscopic radical prostatectomy with an extraperitoneal approach (steps 1 to 5) was performed similarly to the posterior wall reconstruction group.(6) The bladder neck was reconstructed using the "inverted tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra.(7)the anterior wall of the bladder was continuously sutured and fixed onto the muscular membrane of the lower margin of the symphysis pubis using a barb suture.
Sham Group: Laparoscopic radical prostatectomy with an extraperitoneal approach (steps 1 to 5) was performed similarly to the posterior wall reconstruction group.(6) The bladder neck was reconstructed using the "tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra.
Anterior Suspension Group: Laparoscopic radical prostatectomy with an extraperitoneal approach (steps 1 to 5) was performed similarly to the posterior wall reconstruction group.(6) The bladder neck was reconstructed using the "tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra.(7)the anterior wall of the bladder was continuously sutured and fixed onto the muscular membrane of the lower margin of the symphysis pubis using a barb suture.
Assessment Methods for Urinary Incontinence: The primary assessment methods include the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), daily urine pad usage, and 24-hour pad weight measurement. Post radical prostatectomy, the standard for urine control is achieved by either not using any urine pads or experiencing no urine leakage daily or by using only one safety urine pad. The ICIQ-SF and the 24-hour pad test were used to objectively evaluate urinary incontinence immediately after Foley catheter removal. Assessments were repeated at 1, 3, 6, and 12 months post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| posterior reconstruction group | Experimental | Procedure: Posterior ReconstructionIn the posterior wall reconstruction group, laparoscopic radical prostatectomy was performed using an extraperitoneal approach:(1)The extraperitoneal space was established, and Trocar was placed.(2)The Retzius space was separated, the pelvic fascia on both sides of the prostate was incised, the bilateral puboprostatic ligaments were severed, and the dorsal vein complex (DVC) was sutured with 2-0 barb wire.(3)The bladder neck was severed.(4)The prostate and seminal vesicles were separated, the Denonvilliers fascia was opened, and the prostate gland was bluntly and sharply separated from the apex. The lateral prostatic ligaments were severed on both sides.(5)The prostate tip and urethra were severed.(6)Bladder neck reconstruction and bladder neck urethral anastomosis were performed: The bladder neck was reconstructed using the "inverted tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra. |
| posterior reconstruction + anterior suspension group | Experimental | Procedure: Posterior Reconstruction, Procedure: anterior suspensionIn the posterior reconstruction + anterior suspension group, laparoscopic radical prostatectomy with an extraperitoneal approach (steps 1 to 5) was performed similarly to the posterior wall reconstruction group.(6) The bladder neck was reconstructed using the "inverted tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra.(7)the anterior wall of the bladder was continuously sutured and fixed onto the muscular membrane of the lower margin of the symphysis pubis using a barb suture. |
| Sham group | No intervention | –In the posterior reconstruction + anterior suspension group, laparoscopic radical prostatectomy with an extraperitoneal approach (steps 1 to 5) was performed similarly to the posterior wall reconstruction group.(6) The bladder neck was reconstructed using the "tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra. |
| anterior suspension group | Experimental | Procedure: anterior suspensionIn the posterior reconstruction + anterior suspension group, laparoscopic radical prostatectomy with an extraperitoneal approach (steps 1 to 5) was performed similarly to the posterior wall reconstruction group.(6) The bladder neck was reconstructed using the "tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra.(7)the anterior wall of the bladder was continuously sutured and fixed onto the muscular membrane of the lower margin of the symphysis pubis using a barb suture. |
Who may qualify
- Ages
- Up to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Preoperative needle biopsy confirmed prostate cancer; (2) The clinical stage is T1 and T2
Key exclusion criteria (1 listed)
- Diseases that significantly increase the risk of surgery or anesthesia, such as severe cardiovascular diseases, respiratory diseases, and coagulation disorders. (2) Patients with extensive bone metastasis or metastases to other organs (3) patients with a history of urinary incontinence and transurethral resection of the prostate. (4) Tumor invasion of bladder neck.
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 |
|---|---|---|
| Posterior ReconstructionReconstruct the bladder neck using the "inverted tennis racket" method to narrow the bladder neck opening and lengthen the posterior bladder wall. Measure the length of the extended part. | Procedure or surgery | posterior reconstruction + anterior suspension group, posterior reconstruction group |
| anterior suspensionThe anterior wall of the bladder was continuously sutured and fixed onto the muscular membrane of the lower margin of the symphysis pubis using a 3-0 barb suture. | Procedure or surgery | anterior suspension group, posterior reconstruction + anterior suspension group |
Primary outcome
The rate of continence
Time frame: 1 month, 3 months, 6 months and 12 months after surgery
Continence was defined as no more than 1 pads requirement daily by patients for normal physical activity and incontinence was defined as >1 pads daily.
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 31 Dec 2024.
- Background: PubMed 21334025Sutherland DE, Linder B, Guzman AM, Hong M, Frazier HA 2nd, Engel JD, Bianco FJ Jr. Posterior rhabdosphincter reconstruction during robotic assisted radical prostatectomy: results from a phase II randomized clinical trial. J Urol. 2011 Apr;185(4):1262-7. doi: 10.1016/j.juro.2010.11.085. Epub 2011 Feb 22.
- Background: PubMed 37907707Soda T, Otsuka H, Koike S, Okada T. Baseline factors and surgical procedures affecting changes in lower urinary tract symptoms after robot-assisted radical prostatectomy: the impact of nerve-sparing. Int Urol Nephrol. 2024 Mar;56(3):989-997. doi: 10.1007/s11255-023-03859-9. Epub 2023 Oct 31.
- Background: PubMed 39287903Zhao X, Li K, Zhuang R, Liu H, He W, Dong W, Huang H, Huang J, Lin T. Comparison in Efficacy of Periurethral Reconstruction Leading to Urinary Continence Improvement After Robot-assisted Radical Prostatectomy. Ann Surg Oncol. 2024 Dec;31(13):8978-8985. doi: 10.1245/s10434-024-16225-5. Epub 2024 Sep 17.
- Background: PubMed 38492077Ortner G, Honis HR, Bohm J, Konschake M, Tokas T, Nagele U. Improved early continence following laparoscopic radical prostatectomy: the urethral hammock technique. World J Urol. 2024 Mar 16;42(1):168. doi: 10.1007/s00345-024-04857-x.
- Background: PubMed 15828955Sakai I, Harada K, Hara I, Eto H, Miyake H. Intussusception of the bladder neck does not promote early restoration to urinary continence after non-nerve-sparing radical retropubic prostatectomy. Int J Urol. 2005 Mar;12(3):275-9. doi: 10.1111/j.1442-2042.2005.01070.x.
- Background: PubMed 16697841Rocco F, Carmignani L, Acquati P, Gadda F, Dell'Orto P, Rocco B, Bozzini G, Gazzano G, Morabito A. Restoration of posterior aspect of rhabdosphincter shortens continence time after radical retropubic prostatectomy. J Urol. 2006 Jun;175(6):2201-6. doi: 10.1016/S0022-5347(06)00262-X.
- Background: PubMed 18930493Catarin MV, Manzano GM, Nobrega JA, Almeida FG, Srougi M, Bruschini H. The role of membranous urethral afferent autonomic innervation in the continence mechanism after nerve sparing radical prostatectomy: a clinical and prospective study. J Urol. 2008 Dec;180(6):2527-31. doi: 10.1016/j.juro.2008.08.020. Epub 2008 Oct 19.
- Background: PubMed 19931974Walz J, Burnett AL, Costello AJ, Eastham JA, Graefen M, Guillonneau B, Menon M, Montorsi F, Myers RP, Rocco B, Villers A. A critical analysis of the current knowledge of surgical anatomy related to optimization of cancer control and preservation of continence and erection in candidates for radical prostatectomy. Eur Urol. 2010 Feb;57(2):179-92. doi: 10.1016/j.eururo.2009.11.009. Epub 2009 Nov 11.
- Background: PubMed 17084506Harris MJ. The anatomic radical perineal prostatectomy: an outcomes-based evolution. Eur Urol. 2007 Jul;52(1):81-8. doi: 10.1016/j.eururo.2006.10.041. Epub 2006 Oct 30.
- Background: PubMed 9817395Walsh PC. Anatomic radical prostatectomy: evolution of the surgical technique. J Urol. 1998 Dec;160(6 Pt 2):2418-24. doi: 10.1097/00005392-199812020-00010.
- Background: PubMed 19560260Patel VR, Coelho RF, Palmer KJ, Rocco B. Periurethral suspension stitch during robot-assisted laparoscopic radical prostatectomy: description of the technique and continence outcomes. Eur Urol. 2009 Sep;56(3):472-8. doi: 10.1016/j.eururo.2009.06.007. Epub 2009 Jun 16.
- Background: PubMed 30514568Vis AN, van der Poel HG, Ruiter AEC, Hu JC, Tewari AK, Rocco B, Patel VR, Razdan S, Nieuwenhuijzen JA. Posterior, Anterior, and Periurethral Surgical Reconstruction of Urinary Continence Mechanisms in Robot-assisted Radical Prostatectomy: A Description and Video Compilation of Commonly Performed Surgical Techniques. Eur Urol. 2019 Dec;76(6):814-822. doi: 10.1016/j.eururo.2018.11.035. Epub 2018 Dec 2.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior Reconstruction and anterior suspension in people with Posterior Bladder Wall Reconstruction and Anterior Bladder Wall Reconstruction, run by Suzhou Municipal 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 31 Dec 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?
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?
Contact Tengyue Zeng, doctor (86-18351898896, zty19881201@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of continence (time frame: 1 month, 3 months, 6 months and 12 months after surgery). 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 NCT06754488, which also lists 20 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 31 Dec 2024; AzTrials last refreshed its copy on 1 Nov 2026.