TVT Versus TOT in Urinary Stress Incontinence With No Intrinsic Sphincter Deficiency

Study Overview
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Brief Summary
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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
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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).

Official Title
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PROSPECTIVE RANDOMIZED STUDY COMPARING TVT AND TOT IN FEMALE STRESS URINARY INCONTINENCE WITH NO INTRINSIC SPHINCTER DEFICIENCY

Conditions
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Female Urinary Stress Incontinence

Intervention / Treatment
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* Procedure: TVT surgery TOT surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with urinary stress incontinence with no intrinsic sphincter deficiency Women with or without pelvic organ prolapse Exclusion Criteria: Previous incontinence surgery Urge incontinence or overactive bladder Mixed incontinence Intrinsic sphincter deficiency Body mass index>35 Un-willing for randomisation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transvaginal Tape Surgery<br>Randomized 50 patients undergoing TVT | Procedure: TVT surgery TOT surgery<br> <br> |
| Experimental: Transobturator tape surgery<br>Randomized 50 patients undergoing TOT | Procedure: TVT surgery TOT surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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'' | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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''. | 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). | One year | 
| Short term and long term surgical complications | Bleeding,bladder and bowel perforation,mesh erosion etc.. | 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''. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TVT,TOT,Randomized