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

Female Urinary Stress Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903590
• Other study ID #: ZTB-070713
• Secondary ID: ZekaiTahirBurak-
• Status: Completed
• Phase: N/A
• First received: July 13, 2013
• Last updated: June 28, 2014
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2014
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Female Urinary Stress Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• TVT surgery TOT surgery

Locations

Country	Name	City	State
Turkey	Dr Zekai Tahir Burak Woman Health Teaching and Research Hospital	Ankara	Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	One year	No
Secondary	Short term and long term surgical complications	Bleeding,bladder and bowel perforation,mesh erosion etc..	One year	No
Secondary	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	No