stress urinary incontinence
Conditions
Interventions
Experimental group:Medical collagen implants containing polylactic acid microspheres
Control group:Sham treatment control
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1) Females = 18 years old; 2) Symptoms of stress urinary incontinence: involuntary urine leakage from the urethral opening when abdominal pressure is increased such as exertion, laughter, exercise, sneezing or coughing; 3) Patients with stress urinary incontinence symptoms that have persisted for at least 6 months since signing the informed consent form and have been treated with at least 2 or more non-surgical methods (such as behavior change, electrical stimulation, pelvic muscle movement, biofeedback, drug therapy, etc.) for more than 3 months with poor control of urinary incontinence (based on the hospital's diagnostic medical records or the subject's written statement); 4) At least 3 episodes of urinary incontinence within 3 days before signing the informed consent form; 5) Subjects who have a positive pressure-induced test and no urinary urgency and urination during the stress-induced test; 6) Patients with moderate to severe stress urinary incontinence (1-hour urine pad test at baseline is 1 g< 1-hour urine leakage < 50 g), which seriously affects the quality of life; 7) Voluntarily participate in this pilot study and sign the informed consent form; 8) All follow-up patients who are willing to follow the study guidance and complete the requirements.
Exclusion criteria
Exclusion criteria: 1) The urethra is overactive and the tension angle with the horizontal bladder neck = 30°;2) Patients who have undergone urethral surgery or urethral injection or urinary incontinence treatment surgery within 12 months prior to signing the informed consent;3) patients with polyuria (= 2.5L/24 hours);4) Those who have been diagnosed with urinary tract infection within 2 months before signing the informed consent form, or those who have been diagnosed with urethritis, cystitis or vaginitis infection at baseline;5) Body mass index> 35 kg/m2;6) Those who have given birth vaginally within 3 months before signing the informed consent form;7) Patients with ICS Pelvic Organ Prolapse Quantitative Examination (POP-Q) score > stage II;8) Patients who have been treated with medication (including but not limited to selective a1-adrenergic receptor agonists) within 4 weeks before signing the informed consent;9) Patients with autoimmune diseases (such as connective tissue diseases);10) Patients who are taking systemic corticosteroids within 3 months before signing the informed consent form;11) Current cancer or history of cancer within the past 5 years;12) Those who tested positive for hepatitis C virus antibody (anti-HCV), HIV antibody (anti-HIV), and syphilis serospecific antibody (anti-TP); Those who were positive for hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and hepatitis B core antibody (anti-HBcAb);13) Those who have known bleeding disorders, or who have received or plan to receive anticoagulants, antiplatelets, thrombolytics, non-steroidal anti-inflammatory drugs or other drugs known to increase coagulation time within 14 days before signing the informed consent;14) Those who have received or are receiving connective tissue growth factor CTGF therapy within 3 months before screening;15) those who are unable to undergo injection/surgical treatment (e.g., those who are unable to take the lithotomy position after hip arthroplasty) ;16) Those with a history of severe allergies or anaphylaxis, including allergies to PLLA, local anesthetics (such as lidocaine), antibiotics used to treat the urinary tract, or porcine collagen allergy;17) Patients with severe cardiovascular disease;18) Subjects with the following genitourinary diseases:a) vesicoureteral reflux;b) detrusor instability or bladder incompliance;c) Congenital urethral malformationsd) genitourinary fistula (ureteral, bladder, urethral or rectal fistula) or urethral diverticulum or the presence of urethral mucosal injury;e) bladder stones;19) Diabetic patients (fasting blood glucose or preprandial blood glucose greater than 8mmol/L or postprandial blood glucose greater than 12mmol/L);20) patients with genital herpes;21) Those who are currently participating in any other clinical trial, or have participated in another clinical trial within 3 months prior to signing the informed consent; 22) Those who have drug abuse/alcohol abuse or mental disorders;23) Those who are pregnant, breastfeeding or have not taken adequate contraceptive measures and plan to become pregnant during the trial;24) Patients with neurogenic bladder dysfunction (such as abnormal bladder fullness or urination);25) patients with SUI combined with detrusor muscle dysfunction, urinary retention, and small bladder capacity;26) In the opinion of the investigator, it is not suitable for the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1h urinal pad test;72-hour urination diary card; | — |
Secondary
| Measure | Time frame |
|---|---|
| ICI Urinary Incontinence Questionnaire Short Form (ICIQ-SF);Incontinence Quality of Life Questionnaire (I-QOL);24-hour urine pad test; | — |
Countries
China
Contacts
Public ContactDeyi Luo
West China Hospital of Sichuan University
Outcome results
None listed