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Retropubic vs. Transobturator Tension-free Vaginal Tape

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Transobturator Tension-free vaginal tape (TVT-O)
Retropubic Tension-free vaginal tape (TVT)
Sponsored by
Austrian Urogynecology Working Group (AUWG)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring stress urinary incontinence, surgery, tension-free vaginal tape, retropubic, transobturator, quality-of-life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Planned surgery for primary stress incontinence (positive stress test at bladder filling of 300 ml) without concomitant prolapse surgery or hysterectomy
  • Patient able and willing to participate in follow-up
  • Informed consent

Exclusion Criteria:´

  • Detrusor overactivity, predominant complaint overactive bladder (OAB)
  • Major concomitant surgery
  • Prolapse beyond introitus or any prolapse necessitating surgery
  • Previous incontinence surgery other than colporrhaphy
  • Residual urine >100 ml
  • Neurologic disease
  • Allergy to local anesthetic agents
  • Coagulation disorders

Sites / Locations

  • Dept. of Gynecology, Krankenhaus der Barmherzigen Brüder
  • Department of OB/GYN, Medical University of Graz
  • Dept. OB/GYN, Medical University of Vienna
  • Dept. OB/GYN, Wilhelminenspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

Retropubic Tension-free Vaginal Tape (TVT)

Transobturator Tension-free Vaginal Tape (TVT-O)

Outcomes

Primary Outcome Measures

Continence

Secondary Outcome Measures

Quality of life

Full Information

First Posted
February 28, 2007
Last Updated
December 9, 2012
Sponsor
Austrian Urogynecology Working Group (AUWG)
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1. Study Identification

Unique Protocol Identification Number
NCT00441454
Brief Title
Retropubic vs. Transobturator Tension-free Vaginal Tape
Official Title
Retropubic vs. Transobturator Tension-free Vaginal Tape (TVT vs. TVT-O): A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Austrian Urogynecology Working Group (AUWG)

4. Oversight

5. Study Description

Brief Summary
The so-called tension-free vaginal tape (TVT), first described in Sweden in 1996, has become a standard operation worldwide for the treatment of women with stress urinary incontinence. This tape is placed from the vagina behind the pubic bone and exits through the skin of the lower abdomen, just above the pubic bone. In 2001 a urologist in France proposed passing a similar tape laterally (as opposed to behind the pubic bone). This tape is passed through a window of the pelvic bones (the so-called obturator foramen), by what is called a transobturator approach. It is passed through the skin of the thigh (as opposed to the lower abdomen). The reason for this modification was to avoid injuring the bladder and, possibly, provide a more physiologic restoration of the continence mechanism. However, it is unclear whether the lateral (so-called transobturator approach) is as good as or better than the initial approach behind the pubic bone. The purpose of the present study is to compare the standard (retropubic) and the newer (transobturator) approach for the placement of a tape for treating women with stress urinary incontinence.
Detailed Description
After informed consent women scheduled for surgery for stress urinary incontinence are randomized to receive a tension-free vaginal tape either by the retropubic or the transobturator approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
stress urinary incontinence, surgery, tension-free vaginal tape, retropubic, transobturator, quality-of-life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
564 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Retropubic Tension-free Vaginal Tape (TVT)
Arm Title
B
Arm Type
Active Comparator
Arm Description
Transobturator Tension-free Vaginal Tape (TVT-O)
Intervention Type
Device
Intervention Name(s)
Transobturator Tension-free vaginal tape (TVT-O)
Intervention Description
tension-free vaginal tape (TVT)
Intervention Type
Device
Intervention Name(s)
Retropubic Tension-free vaginal tape (TVT)
Intervention Description
Retropubic Tension-free vaginal tape (TVT)
Primary Outcome Measure Information:
Title
Continence
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Planned surgery for primary stress incontinence (positive stress test at bladder filling of 300 ml) without concomitant prolapse surgery or hysterectomy Patient able and willing to participate in follow-up Informed consent Exclusion Criteria:´ Detrusor overactivity, predominant complaint overactive bladder (OAB) Major concomitant surgery Prolapse beyond introitus or any prolapse necessitating surgery Previous incontinence surgery other than colporrhaphy Residual urine >100 ml Neurologic disease Allergy to local anesthetic agents Coagulation disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl F Tamussino, MD
Organizational Affiliation
Medical University of Graz, Dept. OB/GYN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Gynecology, Krankenhaus der Barmherzigen Brüder
City
Graz
ZIP/Postal Code
8020
Country
Austria
Facility Name
Department of OB/GYN, Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Dept. OB/GYN, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Dept. OB/GYN, Wilhelminenspital
City
Vienna
ZIP/Postal Code
1160
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
14644127
Citation
de Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol. 2003 Dec;44(6):724-30. doi: 10.1016/j.eururo.2003.09.003.
Results Reference
background
PubMed Identifier
11859672
Citation
Delorme E. [Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women]. Prog Urol. 2001 Dec;11(6):1306-13. French.
Results Reference
background
PubMed Identifier
11704161
Citation
Tamussino KF, Hanzal E, Kolle D, Ralph G, Riss PA; Austrian Urogynecology Working Group. Tension-free vaginal tape operation: results of the Austrian registry. Obstet Gynecol. 2001 Nov;98(5 Pt 1):732-6. doi: 10.1016/s0029-7844(01)01565-4.
Results Reference
background
PubMed Identifier
8798092
Citation
Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7(2):81-5; discussion 85-6. doi: 10.1007/BF01902378.
Results Reference
background
PubMed Identifier
12114234
Citation
Ward K, Hilton P; United Kingdom and Ireland Tension-free Vaginal Tape Trial Group. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ. 2002 Jul 13;325(7355):67. doi: 10.1136/bmj.325.7355.67.
Results Reference
background
PubMed Identifier
14981369
Citation
Ward KL, Hilton P; UK and Ireland TVT Trial Group. A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am J Obstet Gynecol. 2004 Feb;190(2):324-31. doi: 10.1016/j.ajog.2003.07.029.
Results Reference
background
PubMed Identifier
28464312
Citation
Tammaa A, Aigmuller T, Hanzal E, Umek W, Kropshofer S, Lang PFJ, Ralph G, Riss P, Koelle D, Jundt K, Tamussino K, Bjelic-Radisic V; Austrian Urogynecology Working Group. Retropubic versus transobturator tension-free vaginal tape (TVT vs TVT-O): Five-year results of the Austrian randomized trial. Neurourol Urodyn. 2018 Jan;37(1):331-338. doi: 10.1002/nau.23298. Epub 2017 May 2.
Results Reference
derived
PubMed Identifier
24819327
Citation
Aigmuller T, Tammaa A, Tamussino K, Hanzal E, Umek W, Kolle D, Kropshofer S, Bjelic-Radisic V, Haas J, Giuliani A, Lang PF, Preyer O, Peschers U, Jundt K, Ralph G, Dungl A, Riss PA; Austrian TVT vs. TVT-O Study Group. Retropubic vs. transobturator tension-free vaginal tape for female stress urinary incontinence: 3-month results of a randomized controlled trial. Int Urogynecol J. 2014 Aug;25(8):1023-30. doi: 10.1007/s00192-014-2384-z. Epub 2014 May 13.
Results Reference
derived

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Retropubic vs. Transobturator Tension-free Vaginal Tape

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