Trial Title:
The Role of Levator Ani Muscle Reconstruction Technology in Urinary Incontinence Recovery
NCT ID:
NCT06543420
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Urinary Incontinence
Enuresis
Conditions: Keywords:
Prostate cancer
Levator ani muscle reconstruction
Urinary incontinence recovery
Robot-assisted radical prostatectomy
Randomized controlled trial
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
lateral reconstruction
Description:
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.
Arm group label:
lateral reconstruction group
Intervention type:
Procedure
Intervention name:
posterior reconstruction
Description:
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.
Arm group label:
posterior reconstruction group
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. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosed with prostate cancer and preoperative clinical stage of cT2~T3aN0M0
- Complies with the indications for RARP surgery
Exclusion Criteria:
- 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Zip:
100034
Country:
China
Status:
Recruiting
Contact:
Last name:
Kan Gong
Phone:
(86)-010-83572057
Email:
kan.gong@bjmu.edu.cn
Start date:
July 22, 2024
Completion date:
July 21, 2026
Lead sponsor:
Agency:
Peking University First Hospital
Agency class:
Other
Source:
Peking University First Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06543420
