A Technique Improves Urinary Continence in Patients Undergoing Laparoscopic Radical Prostatectomy

NCT06754488 | Recruiting DMC

• 1 other identifier: K2024135K01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Posterior Bladder Wall Reconstruction; Anterior Bladder Wall Reconstruction; Anterior Bladder Wall Suspension

Keywords

prostate cancer; early urinary continence; laparoscopic radical prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month, 3 months, 6 months and 12 months after surgery

Study Arms (4)

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.

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.

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.

Procedure: anterior suspension

Interventions

Posterior Reconstruction PROCEDURE

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.

posterior reconstruction + anterior suspension group; posterior reconstruction group

anterior suspension PROCEDURE

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.

anterior suspension group; posterior reconstruction + anterior suspension group

Eligibility Criteria

• Age: Up to 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Preoperative needle biopsy confirmed prostate cancer; (2) The clinical stage is T1 and T2

You may not qualify if:

• (1) 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.

Sponsors & Collaborators

• Suzhou Municipal Hospital: lead

Study Sites (1)

Suzhou Municipal Hospital

Suzhou, Jiangsu, 215000, China

RECRUITING

Related Publications (20)

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MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Posterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Arthroplasty; Surgical Procedures, Operative; Plastic Surgery Procedures

Central Study Contacts

Tengyue Zeng, doctor

CONTACT

86-18351898896; zty19881201@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 31, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-06

Locations

CN (1)