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The Role of Levator Ani Muscle Reconstruction Technology in Urinary Incontinence Recovery

P

Peking University

Status

Enrolling

Conditions

Prostate Cancer

Treatments

Procedure: lateral reconstruction
Procedure: posterior reconstruction

Study type

Interventional

Funder types

Other

Identifiers

NCT06543420
chfcj2024

Details and patient eligibility

About

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.

Full 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.

Enrollment

192 estimated patients

Sex

Male

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

192 participants in 3 patient groups

lateral reconstruction group
Experimental group
Description:
After RARP surgery, lateral reconstruction is performed
Treatment:
Procedure: lateral reconstruction
posterior reconstruction group
Experimental group
Description:
After RARP surgery, posterior reconstruction is performed
Treatment:
Procedure: posterior reconstruction
control group
No Intervention group
Description:
No lateral or posterior reconstruction is performed after RARP surgery

Trial contacts and locations

1

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Central trial contact

Kan Gong, MD

Data sourced from clinicaltrials.gov

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