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

NCT ID: NCT01903590

Last Updated: 2014-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-06-30

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).

Conditions

Female Urinary Stress Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Transvaginal Tape Surgery

Randomized 50 patients undergoing TVT

Group Type: ACTIVE_COMPARATOR

TVT surgery TOT surgery

Intervention Type: PROCEDURE

Transobturator tape surgery

Randomized 50 patients undergoing TOT

Group Type: EXPERIMENTAL

TVT surgery TOT surgery

Intervention Type: PROCEDURE

Interventions

TVT surgery TOT surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sabri Cavkaytar

Obstetrics and Gynecology specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sabri Cavkaytar, MD

Role: PRINCIPAL_INVESTIGATOR

Zekai Tahir Burak Women's Health Research and Education Hospital

Locations

Dr Zekai Tahir Burak Woman Health Teaching and Research Hospital

Ankara, Cankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ZekaiTahirBurak-SCavkaytar1

Identifier Type: REGISTRY

Identifier Source: secondary_id

ZTB-070713

Identifier Type: -

Identifier Source: org_study_id