Retropubic vs. Transobturator Tension-free Vaginal Tape

NCT00441454 | Completed

• 1 other identifier: TVT vs. TVT-O
• Study Type: interventional
• Target: 564
• Locations: 1 country
• Sites: 4

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.

Conditions

Stress Urinary Incontinence

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Continence

  5 years

Secondary Outcomes (1)

• Quality of life

  5 years

Study Arms (2)

A

ACTIVE COMPARATOR

Retropubic Tension-free Vaginal Tape (TVT)

Device: Retropubic Tension-free vaginal tape (TVT)

B

ACTIVE COMPARATOR

Transobturator Tension-free Vaginal Tape (TVT-O)

Device: Transobturator Tension-free vaginal tape (TVT-O)

Interventions

Transobturator Tension-free vaginal tape (TVT-O) DEVICE

tension-free vaginal tape (TVT)

B

Retropubic Tension-free vaginal tape (TVT) DEVICE

Retropubic Tension-free vaginal tape (TVT)

A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Austrian Urogynecology Working Group (AUWG): lead

Study Sites (4)

Dept. of Gynecology, Krankenhaus der Barmherzigen Brüder

Graz, 8020, Austria

Location

Department of OB/GYN, Medical University of Graz

Graz, 8036, Austria

Location

Dept. OB/GYN, Medical University of Vienna

Vienna, 1090, Austria

Location

Dept. OB/GYN, Wilhelminenspital

Vienna, 1160, Austria

Location

Related Publications (8)

• 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.

  PMID: 14644127 BACKGROUND

• 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.

  PMID: 11859672 BACKGROUND

• 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.

  PMID: 11704161 BACKGROUND

• 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.

  PMID: 8798092 BACKGROUND

• 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.

  PMID: 12114234 BACKGROUND

• 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.

  PMID: 14981369 BACKGROUND

• 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.

  PMID: 28464312 DERIVED

• 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.

  PMID: 24819327 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karl F Tamussino, MD

  Medical University of Graz, Dept. OB/GYN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: February 28, 2007
• First Posted: March 1, 2007
• Study Start: September 1, 2004
• Primary Completion: June 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

AU (4)