Female Urinary Stress Incontinence
Conditions
Keywords
TVT,TOT,Randomized
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).
Interventions
PROCEDURETVT surgery TOT surgery
Sponsors
Zekai Tahir Burak Women's Health Research and Education Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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''. |
Countries
Turkey (Türkiye)
Outcome results
None listed