A Technique Improves Urinary Continence in Patients Undergoing Laparoscopic Radical Prostatectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeUp to 79
SponsorSuzhou Municipal Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Factorial

Treatments tested in this trial

  • Posterior Reconstruction

    Procedure/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 suspension

    Procedure/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.

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: posterior reconstruction groupExperimental treatment 1 intervention
Group B: posterior reconstruction + anterior suspension groupExperimental treatment 2 interventions
Group C: Sham groupNo intervention 0 interventions
Group D: anterior suspension groupExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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