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

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

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.

Study Overview

• Status: Completed
• Conditions: Female Urinary Stress Incontinence
• Intervention / Treatment: Procedure: TVT surgery TOT surgery

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).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Cankaya
    • Ankara, Cankaya, Turkey, 06590
      • Dr Zekai Tahir Burak Woman Health Teaching and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Transvaginal Tape Surgery; Randomized 50 patients undergoing TVT	Procedure: TVT surgery TOT surgery
EXPERIMENTAL: Transobturator tape surgery; Randomized 50 patients undergoing TOT	Procedure: TVT surgery TOT surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
• Investigators: Principal Investigator: Sabri Cavkaytar, MD, Zekai Tahir Burak Women's Health Research and Education Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: July 13, 2013
• First Submitted That Met QC Criteria: July 16, 2013
• First Posted (ESTIMATE): July 19, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 1, 2014
• Last Update Submitted That Met QC Criteria: June 28, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: TVT,TOT,Randomized
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: ZTB-070713; ZekaiTahirBurak-SCavkaytar1 (REGISTRY: ZekaiTahirBurak)