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

The Role of Levator Ani Muscle Reconstruction Technology in Urinary Incontinence Recovery After Robot Assisted Radical Prostatectomy: a Randomized Controlled Clinical Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06543420
Enrollment
192
Registered
2024-08-09
Start date
2024-07-22
Completion date
2026-07-21
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate cancer, Levator ani muscle reconstruction, Urinary incontinence recovery, Robot-assisted radical prostatectomy, Randomized controlled trial

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.

Interventions

PROCEDURElateral 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.

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.

Sponsors

Peking University First Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recovery rate of urinary incontinence1,3,6,9,12 months after operationUrinary incontinence recovery is defined as using 0 urinary pads per day

Secondary

MeasureTime frameDescription
The International Consultation on Incontinence Questionnaire Short-form(ICIQ-SF) Score1,3,6,9,12 months after operationICIQ-SF is a questionnaire used to evaluate urinary incontinence and assess the recovery of postoperative urinary incontinence in patients. The range of scores is from 0 to 21, with higher scores indicating more severe urinary incontinence.
Incontinence Quality of Life Questionnaire(I-QOL) Score1,3,6,9,12 months after operationI-QoL is a questionnaire used to evaluate the quality of life of patients with urinary incontinence after surgery. The range of scores is from 0 to 100, with higher scores indicating higher quality of life.
Perioperative and postoperative complications1,3,6,9,12 months after operationCollect perioperative and postoperative complications such as bleeding and pain to compare the differences between two reconstruction methods and non reconstruction methods.
Prostate-specific antigen1,3,6,9,12 months after operationBiochemical recurrence is defined as two consecutive postoperative PSA levels above 0.2 ng/ml with an upward trend
Duration of operationimmediately after operationThe purpose of collecting surgical duration is to compare whether there are differences between two reconstruction techniques and no reconstruction.

Countries

China

Contacts

Primary ContactKan Gong, MD
kan.gong@bjmu.edu.cn(86)-010-83572075

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026