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

Primary Purpose

Female Urinary Stress Incontinence

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TVT surgery TOT surgery
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Urinary Stress Incontinence focused on measuring TVT,TOT,Randomized

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Dr Zekai Tahir Burak Woman Health Teaching and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Transvaginal Tape Surgery

Transobturator tape surgery

Arm Description

Randomized 50 patients undergoing TVT

Randomized 50 patients undergoing TOT

Outcomes

Primary Outcome Measures

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''

Secondary Outcome Measures

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''.
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).
Short term and long term surgical complications
Bleeding,bladder and bowel perforation,mesh erosion etc..
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''.

Full Information

First Posted
July 13, 2013
Last Updated
June 28, 2014
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01903590
Brief Title
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Urinary Stress Incontinence
Keywords
TVT,TOT,Randomized

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transvaginal Tape Surgery
Arm Type
Active Comparator
Arm Description
Randomized 50 patients undergoing TVT
Arm Title
Transobturator tape surgery
Arm Type
Experimental
Arm Description
Randomized 50 patients undergoing TOT
Intervention Type
Procedure
Intervention Name(s)
TVT surgery TOT surgery
Primary Outcome Measure Information:
Title
Comparison of the efficiency of TVT and TOT in stress incontinence with no intrinsic deficiency
Description
Postoperative UDI-6 and IIQ-7 <10 and negative cough test will be defined as ''cured''
Time Frame
One year
Secondary Outcome Measure Information:
Title
Objective effectiveness by cough test at 6 and 12 th months postoperatively
Description
A patient with a bladder filled 300 cc saline will cough and if no leakage of urine,the patient will be described as ''cured''.
Time Frame
One year
Title
Subjective effectiveness by UDI-6 and IIQ-7 at 6-12 th months postoperatively
Description
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).
Time Frame
One year
Title
Short term and long term surgical complications
Description
Bleeding,bladder and bowel perforation,mesh erosion etc..
Time Frame
One year
Title
The prevalence of voiding dysfunction at 1 and 12 th months postoperatively
Description
Postoperative residual volume after first voiding >100 cc ,difficulty in voiding will be described as ''voiding dysfunction''.
Time Frame
One year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabri Cavkaytar, MD
Organizational Affiliation
Zekai Tahir Burak Women's Health Research and Education Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Zekai Tahir Burak Woman Health Teaching and Research Hospital
City
Ankara
State/Province
Cankaya
ZIP/Postal Code
06590
Country
Turkey

12. IPD Sharing Statement

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

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