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Retropubic vs. Transobturator Tension-free Vaginal Tape

NCT ID: NCT00441454

Last Updated: 2012-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

564 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Stress Urinary Incontinence

Keywords

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stress urinary incontinence surgery tension-free vaginal tape retropubic transobturator quality-of-life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Retropubic Tension-free Vaginal Tape (TVT)

Group Type ACTIVE_COMPARATOR

Retropubic Tension-free vaginal tape (TVT)

Intervention Type DEVICE

Retropubic Tension-free vaginal tape (TVT)

B

Transobturator Tension-free Vaginal Tape (TVT-O)

Group Type ACTIVE_COMPARATOR

Transobturator Tension-free vaginal tape (TVT-O)

Intervention Type DEVICE

tension-free vaginal tape (TVT)

Interventions

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Transobturator Tension-free vaginal tape (TVT-O)

tension-free vaginal tape (TVT)

Intervention Type DEVICE

Retropubic Tension-free vaginal tape (TVT)

Retropubic Tension-free vaginal tape (TVT)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Austrian Urogynecology Working Group (AUWG)

OTHER

Sponsor Role lead

Responsible Party

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Karl Tamussino, MD

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karl F Tamussino, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Dept. OB/GYN

Locations

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Dept. of Gynecology, Krankenhaus der Barmherzigen Brüder

Graz, , Austria

Site Status

Department of OB/GYN, Medical University of Graz

Graz, , Austria

Site Status

Dept. OB/GYN, Medical University of Vienna

Vienna, , Austria

Site Status

Dept. OB/GYN, Wilhelminenspital

Vienna, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type BACKGROUND
PMID: 14644127 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11859672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11704161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8798092 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12114234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14981369 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28464312 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24819327 (View on PubMed)

Other Identifiers

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TVT vs. TVT-O

Identifier Type: -

Identifier Source: org_study_id