The aim of this study is to compare trans-vaginal tape(TVT) and trans-obturator tape(TOT) procedure in female urinary stress incontinence with no intrinsic sphincter deficiency.
Patients with isolated stress incontinence attending to Dr Zekai Tahir Burak Woman Health Teaching and Research Hospital Urogynecology Department will be prospectively randomized,by a computer generated randomisation code,to the TVT or TOT. The patients will be aware of the type of the surgical procedure before the operation. Preoperative evaluation includes clinical history,urinanalysis,pelvic examination QoL assessment and urodynamic study. QoL included Urogenital Distress Inventory Short Form (UDI-6) and the Incontinence Impact Questionnaire Short Form( IIQ-7).Urodynamic study includes cystometry,urethral profilometry and Valsalva leak point pressure (VLPP).In all patients,pelvic floor defect will be evaluated according to the POP quantification (POPQ) staging.To diagnose the occult stress incontinence in patients with pelvic prolapse, a cough test after reducing the prolapse will be performed.Patients will be followed up at 6 and 12 months postoperatively.Objective cure is defined as a negative cough stress test .Negative cough stress test ,but occasional urine leakage during stress will be considered ''improved''. Postoperative subjective outcomes will be categorized as follows:cured (UDI-6 and IIQ-7 postoperative\<10), improved (UDI-6 and IIQ-7 if postoperative\>preoperative) and worsened (UDI-6 and IIQ-7 if postoperative\<preoperative).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Dr Zekai Tahir Burak Woman Health Teaching and Research Hospital
Ankara, Cankaya, Turkey (Türkiye)
Comparison of the efficiency of TVT and TOT in stress incontinence with no intrinsic deficiency
Postoperative UDI-6 and IIQ-7 \<10 and negative cough test will be defined as ''cured''
Time frame: One year
Objective effectiveness by cough test at 6 and 12 th months postoperatively
A patient with a bladder filled 300 cc saline will cough and if no leakage of urine,the patient will be described as ''cured''.
Time frame: One year
Subjective effectiveness by UDI-6 and IIQ-7 at 6-12 th months postoperatively
Postoperative subjective outcomes will be categorized as follows:cured (UDI-6 and IIQ-7 postoperative\<10), improved (UDI-6 and IIQ-7 if postoperative\>preoperative) and worsened (UDI-6 and IIQ-7 if postoperative\<preoperative).
Time frame: One year
Short term and long term surgical complications
Bleeding,bladder and bowel perforation,mesh erosion etc..
Time frame: One year
The prevalence of voiding dysfunction at 1 and 12 th months postoperatively
Postoperative residual volume after first voiding \>100 cc ,difficulty in voiding will be described as ''voiding dysfunction''.
Time frame: One year
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