Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ZekaiTahirBurak-SCavkaytar1 | Registry Identifier | ZekaiTahirBurak |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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\
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transvaginal Tape Surgery | Active Comparator | Randomized 50 patients undergoing TVT |
|
| Transobturator tape surgery | Experimental | Randomized 50 patients undergoing TOT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TVT surgery TOT surgery | Procedure |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sabri Cavkaytar, MD | Zekai Tahir Burak Women's Health Research and Education Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Zekai Tahir Burak Woman Health Teaching and Research Hospital | Ankara | Cankaya | 06590 | Turkey (Türkiye) |
Not provided
Not provided
Not provided
Not provided
Not provided
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\ |
| 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 |