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

Zekai Tahir Burak Women's Health Research and Education Hospital

Status: Completed

Conditions: Female Urinary Stress Incontinence

Treatments: Procedure: TVT surgery TOT surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01903590

ZekaiTahirBurak-SCavkaytar1 (Registry Identifier)

ZTB-070713

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Transvaginal Tape Surgery

Active Comparator group

Description:

Randomized 50 patients undergoing TVT

Treatment:

Procedure: TVT surgery TOT surgery

Transobturator tape surgery

Experimental group

Description:

Randomized 50 patients undergoing TOT

Treatment:

Procedure: TVT surgery TOT surgery