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

NCT ID: NCT06543420

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-22
• Study Completion Date: 2026-07-21

Brief 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

lateral reconstruction group

After RARP surgery, lateral reconstruction is performed

Group Type: EXPERIMENTAL

lateral reconstruction

Intervention Type: PROCEDURE

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.

posterior reconstruction group

After RARP surgery, posterior reconstruction is performed

Group Type: EXPERIMENTAL

posterior reconstruction

Intervention Type: PROCEDURE

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.

control group

No lateral or posterior reconstruction is performed after RARP surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

lateral reconstruction

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.

Intervention Type: PROCEDURE

posterior reconstruction

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

GONG Kan

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kan Gong

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Kan Gong, MD

Role: CONTACT

kan.gong@bjmu.edu.cn

(86)-010-83572075

Facility Contacts

Kan Gong

Role: primary

kan.gong@bjmu.edu.cn

(86)-010-83572057

Other Identifiers

chfcj2024

Identifier Type: -

Identifier Source: org_study_id