A Randomized Controlled Clinical Trials On The Safety And Efficacy Of Regen Sling Used In The Treatment Of Female Stress Urinary Incontinence

Objective: To evaluate the safety and efficacy of Regen Sling used in the treatment of female stress urinary incontinence.Methods: This study is a random,single blind,positive parallel comparison,clinical test.Female patients with stress urinary incontinence that meet certain criteria were 18 cases.All patients were carried out TVT-O surgery by the same doctor,different surgical instruments used in the two groups.The experimental group,9 cases,used no tension incontinence suspension system(trade name: Regen Sling)developed by Medprin Regenerative Medical Technologies Co.,Ltd,(shenzhen).The control group,9 cases,used Tension Free Vaginal Tape-obturator System(trade name.TVT-O)developed by Ethicon SARL.Compare two groups of operation time,surgical blood loss,postoperation pain VAS score,postoperative catheter indwelling time,postoperative residual urine,blood routine,the quality of life(Incontinence Inpact Questionnaire IIQ-7)score,sexual life quality(The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12,PISQ-12)score and whether there is erosion and other complications,and confirm differences in efficacy in order to evaluating the efficacy of the experimental group products.Results: Basic information of RS and ES group,such as the patient’s age,leakage time,preoperative WBC,1h pad test,the quality of life score,sexual life quality score,abdominal and pelvic surgery history had no statistically significant difference {age 53.33(age 37-64)VS age 54.78(age 43-64),P>0.05;6.18 years(2-20 years)VS 9.22 years(2-27 years),P>0.05;6.65*109/L(5.09-9.80*109/L)VS 6.28*109/L(5.15-8.58*109/L),P>0.05;54.32 g(54.32-9.8 g)VS 38.94 g(3.4-40.7 g),P>0.05;18.67 points(9-27 points)VS 15.33 points(9-25 points),P > 0.05;40.67 points(30-49 points)VS 42.67 points(32-53 points),P > 0.05;66.67%(6/9)VS 33.33%(3/9),P > 0.05).Clinical data of RS and ES group,such as operation time,blood loss,intraoperative complications,postoperative pain VAS score,catheter indwelling time,postoperative residual urine,postoperative blood routine,postoperative hospitalization time had no statistically significant differences {43.67 minutes(30-70 minutes)VS 43.67 minutes(30-170 minutes),P > 0.05;5.78 ml(1-20 ml)VS 4.67 ml(1-6 ml),P > 0.05;0 VS 11.11%,P > 0.05;3.78 points(2-6 points)VS 4.67 points(2-7 points),P > 0.05;1.11 d(1-2 d)VS 2.00 d(1-6 d),P > 0.05;59.00 ml(0-298 ml)VS 138.78 ml(0-630 ml),P > 0.05;10.58*109/L(6.43-16.75*109/L)VS 9.72*109/L(5.92-12.59*109/L),P > 0.05;2.22 d(1-4 d)VS 2.78 d(2-7 d),P > 0.05).3 months follow-up of RS and ES group,the quality of life score,the complication rate,had no statistically significant difference {8.73 points(7-56 points)VS 7.56 points(7-12 points),P > 0.05;66.67% VS 66.67%,P > 0.05);6 months follow-up of RS and ES group,the quality of life score,the sexual life quality score,the complication rate,had no statistically significant difference {7.67 points(7-13 points)VS 7.00 points(7-7 points),P > 0.05;43.67 points(36-58 points)VS 41.22(36-50 points),P > 0.05;22.22% VS 33.33%,P > 0.05);9 months follow-up of RS and ES group,the quality of life score,the sexual life quality score,the complication rate,had no statistically significant difference {7.00 points(7-7 points)VS 7.00 points(7-7 points);40.00 points(36-58 points)VS 39.67 points(36-52 points),P > 0.05;22.22% VS 33.33%,P > 0.05).The cure rate of RS group and ES group had no statistically difference {88.89%(8/9)VS 88.89%(7/9),P > 0.05};The improvement rate of RS group and ES group had no statistically difference{100%(9/9)VS 100%(8/9),P > 0.05};The failure rate of RS group and ES group had no statistically difference{0%(0/9)VS 0%(1/9),P > 0.05};The effective rate of RS group and ES group had no statistically difference{100%(9/9)VS 100%(8/9),P > 0.05};The incidence of adverse events rate in RS group and ES group had no statistically difference{66.67%(6/9)VS 66.67%(6/9),P > 0.05}.Conclusions:1 No tension incontinence suspension system,Regen Sling,developed by Medprin Regenerative Medical Technologies Co.,Ltd,(shenzhen),used in the treatment of female stress urinary incontinence,is safe and effective2 TVT-O,used in the treatment of female stress urinary incontinence,have a high effective rate,but also a high incidence of adverse events,surgeons need to carefully select patients matching indications,explain detailed surgical effect and risks to the patients before treatment.