Clinical trial NCT06543420: The Role of Levator Ani Muscle Reconstruction Technology in Urinary Incontinence Recovery
Official title: The Role of Levator Ani Muscle Reconstruction Technology in Urinary Incontinence Recovery After Robot Assisted Radical Prostatectomy: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Levator ani muscle reconstruction
Urinary incontinence recovery
Robot-assisted radical prostatectomy
Randomized controlled trial
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 192
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recovery rate of urinary incontinence
timeFrame: 1,3,6,9,12 months after operation
Secondary outcomes:
measure: The International Consultation on Incontinence Questionnaire Short-form(ICIQ-SF) Score
timeFrame: 1,3,6,9,12 months after operation
measure: Incontinence Quality of Life Questionnaire(I-QOL) Score
timeFrame: 1,3,6,9,12 months after operation
measure: Perioperative and postoperative complications
timeFrame: 1,3,6,9,12 months after operation
measure: Prostate-specific antigen
timeFrame: 1,3,6,9,12 months after operation
measure: Duration of operation
timeFrame: immediately after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Kan Gong
role: PRINCIPAL_INVESTIGATOR
References: