Objective To evaluate the safety and efficacy of the domestic urinary incontinence repair system through tension-free vaginal tape-obturator to treat the female stress urinary incontinence. Methods From November 2013 to… Click to show full abstract
Objective To evaluate the safety and efficacy of the domestic urinary incontinence repair system through tension-free vaginal tape-obturator to treat the female stress urinary incontinence. Methods From November 2013 to May 2015, 53 patients were recruited into this multicetral randomiszd controlled clinical trail in our hospital. All the cases were randomly divided into control group and trial group. The patients in control group underwent the TVT-O system, the patients in trial group underwent urinary incontinence repair system. All patients received the tension-free vaginal tape-obturator. Preoperative, intraoperative, postoperative and follow-up situation including the clinical curative efficacy were compared. Post-operation follow-up included 1 hour urine pad test, international incontinence questionnaire (ICI-Q-SF) symptom scores, comfort/satisfaction etc. Results ①There was no significant difference in age, body mass index, course of disease, residual urine between the two groups (P>0.05). ②The difference was not statistically significant in 1 hour urine pad test, international incontinence questionnaire (ICI-Q-SF) symptom scores before operation between the control group and trial group (P>0.05). There was no statistical significance in 1 hour urine pad test and international incontinence questionnaire (ICI-Q-SF) symptom scores between the control group and trial group(P>0.05). There was statistically significant difference in 1 hour urine pad test between the pre-operation and 1 year after the operation in both groups (P<0.05). ③Postoperative patients'comfort/satisfaction reached a good or satisfactory between two groups.④Operative complications of two groups including: three patients in the control group suffered thigh root pain after the operation, and in the other group four cases had thigh root pain, one had difficulty of urination and one had postoperative hematuria, but the symptoms improved significantly after conservative treatment. Conclusions Domestic urinary incontinence repair system in the treatment of female stress urinary incontinence is safe and effective by the tension-free vaginal tape-obturator, and also can obviously improve the patient's quality of life. Key words: Urinary Incontinence, Stress; Quality of Life; Multicenter Study
               
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