Clinical trial NCT01903590: TVT Versus TOT in Urinary Stress Incontinence With No Intrinsic Sphincter Deficiency
Official title: PROSPECTIVE RANDOMIZED STUDY COMPARING TVT AND TOT IN FEMALE STRESS URINARY INCONTINENCE WITH NO INTRINSIC SPHINCTER DEFICIENCY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Urinary Stress Incontinence
Keywords: TVT,TOT,Randomized
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Comparison of the efficiency of TVT and TOT in stress incontinence with no intrinsic deficiency
timeFrame: One year
Secondary outcomes:
measure: Objective effectiveness by cough test at 6 and 12 th months postoperatively
timeFrame: One year
measure: Subjective effectiveness by UDI-6 and IIQ-7 at 6-12 th months postoperatively
timeFrame: One year
measure: Short term and long term surgical complications
timeFrame: One year
measure: The prevalence of voiding dysfunction at 1 and 12 th months postoperatively
timeFrame: One year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr Zekai Tahir Burak Woman Health Teaching and Research Hospital
state: Cankaya
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: Sabri Cavkaytar, MD
role: PRINCIPAL_INVESTIGATOR
References: