Retropubic vs. Transobturator Tension-free Vaginal Tape

Stress Urinary Incontinence Clinical Trial

Official title:

Retropubic vs. Transobturator Tension-free Vaginal Tape (TVT vs. TVT-O): A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441454
• Other study ID #: TVT vs. TVT-O
• Status: Completed
• Phase: N/A
• First received: February 28, 2007
• Last updated: December 9, 2012
• Start date: September 2004
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Austrian Urogynecology Working Group (AUWG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 564
• Est. completion date: October 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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

Locations

Country	Name	City	State
Austria	Department of OB/GYN, Medical University of Graz	Graz
Austria	Dept. of Gynecology, Krankenhaus der Barmherzigen Brüder	Graz
Austria	Dept. OB/GYN, Medical University of Vienna	Vienna
Austria	Dept. OB/GYN, Wilhelminenspital	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Austrian Urogynecology Working Group (AUWG)

Country where clinical trial is conducted

Austria, 

References & Publications (6)

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. — View 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. — View Citation

Tamussino KF, Hanzal E, Kölle 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continence		5 years
Secondary	Quality of life		5 years