TVT Versus TOT in Urinary Stress Incontinence With No Intrinsic Sphincter Deficiency
- Conditions
- Female Urinary Stress Incontinence
- Interventions
- Procedure: TVT surgery TOT surgery
- Registration Number
- NCT01903590
- Lead Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- Women with urinary stress incontinence with no intrinsic sphincter deficiency
- Women with or without pelvic organ prolapse
- Previous incontinence surgery
- Urge incontinence or overactive bladder
- Mixed incontinence
- Intrinsic sphincter deficiency
- Body mass index>35
- Un-willing for randomisation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transvaginal Tape Surgery TVT surgery TOT surgery Randomized 50 patients undergoing TVT Transobturator tape surgery TVT surgery TOT surgery Randomized 50 patients undergoing TOT
- Primary Outcome Measures
Name Time Method Comparison of the efficiency of TVT and TOT in stress incontinence with no intrinsic deficiency One year Postoperative UDI-6 and IIQ-7 \<10 and negative cough test will be defined as ''cured''
- Secondary Outcome Measures
Name Time Method Objective effectiveness by cough test at 6 and 12 th months postoperatively One year A patient with a bladder filled 300 cc saline will cough and if no leakage of urine,the patient will be described as ''cured''.
Subjective effectiveness by UDI-6 and IIQ-7 at 6-12 th months postoperatively One year 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).
Short term and long term surgical complications One year Bleeding,bladder and bowel perforation,mesh erosion etc..
The prevalence of voiding dysfunction at 1 and 12 th months postoperatively One year Postoperative residual volume after first voiding \>100 cc ,difficulty in voiding will be described as ''voiding dysfunction''.
Trial Locations
- Locations (1)
Dr Zekai Tahir Burak Woman Health Teaching and Research Hospital
🇹🇷Ankara, Cankaya, Turkey