Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women

NCT00234754 | Completed

• 2 other identifiers: 18421200400964
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

Stress urinary incontinence (SUI) is a health concern for many women. The transvaginal tape (TVT) surgery has become a common procedure to address the problem. Another surgery is now available, trans-obturator tape (TOT). The investigators will compare these 2 approaches to dealing with SUI and follow the women for 1 year. Women will also be followed at 5 years after surgery.

Conditions

Stress Urinary Incontinence

Keywords

Incontinence; Surgery; Trans-vaginal tape; Trans-obturator tape

Outcome Measures

Primary Outcomes (2)

• How effective is TOT compared to TVT in terms of objective cure at 12 months postoperatively?

  Objective evidence of SUI will be obtained using a standardised pad test undertaken at 12 months following surgery. The pad test will be carried out using a modification of the International Continence Society (ICS) recommendations. Women will be considered 'cured' if the pad weight gain is less than 1g over the test period. This is the definition of cure used by Ward and will allow comparison with that trial.

  1 year

• Vaginal erosion or other serious adverse outcomes of surgery over 5 years postoperatively

  5 years

Secondary Outcomes (12)

• How effective is TOT compared to TVT in terms of subjective cure 12 months postoperatively?

  1 year

• Incontinence-specific quality of life at 6 weeks and 12 months postoperatively?

  1 year

• Satisfaction with surgery at 12 months postoperatively?

  1 year

• Return to usual activities and usual sex life after surgery?

  6 weeks and 1 year

• The prevalence of voiding dysfunction at 12 months postoperatively?

  1 year

Study Arms (2)

1

ACTIVE COMPARATOR

Trans-vaginal tape Surgery

Procedure: TVT Surgery TOT Surgery

2

EXPERIMENTAL

Trans-obturator tape surgery

Procedure: TVT Surgery TOT Surgery

Interventions

TVT Surgery TOT Surgery PROCEDURE

TVT surgery and TOT surgery

1; 2

Eligibility Criteria

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

You may qualify if:

• Women with type II stress incontinence, defined as leaking with increased abdominal pressure
• Are eligible for both types of surgery

You may not qualify if:

• Have vaginal prolapse requiring surgical repair
• Have had previous incontinence surgery
• Have overactive bladder or incontinence is caused only by bladder overflow
• Intend to have further children
• Have Alzheimer's or Parkinson's disease, progressive neurological disease such as multiple sclerosis, or are immunocompromised
• Are unable to understand English
• Will be unavailable for follow-up

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Alberta Health services: collaborator
• Boston Scientific Corporation: collaborator
• Alberta Heritage Foundation for Medical Research: collaborator

Study Sites (1)

Calgary Health Region

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (5)

• Ross S, Robert M, Lier D, Eliasziw M, Jacobs P. Surgical management of stress urinary incontinence in women: safety, effectiveness and cost-utility of trans-obturator tape (TOT) versus tension-free vaginal tape (TVT) five years after a randomized surgical trial. BMC Womens Health. 2011 Jul 22;11:34. doi: 10.1186/1472-6874-11-34.

  PMID: 21781314 BACKGROUND

• Ross S, Robert M, Swaby C, Dederer L, Lier D, Tang S, Brasher P, Birch C, Cenaiko D, Mainprize T, Murphy M, Carlson K, Baverstock R, Jacobs P, Williamson T. Transobturator tape compared with tension-free vaginal tape for stress incontinence: a randomized controlled trial. Obstet Gynecol. 2009 Dec;114(6):1287-1294. doi: 10.1097/AOG.0b013e3181c2a151.

  PMID: 19935032 RESULT

• Lier D, Ross S, Tang S, Robert M, Jacobs P; Calgary Women's Pelvic Health Research Group. Trans-obturator tape compared with tension-free vaginal tape in the surgical treatment of stress urinary incontinence: a cost utility analysis. BJOG. 2011 Apr;118(5):550-6. doi: 10.1111/j.1471-0528.2010.02845.x. Epub 2011 Feb 4.

  PMID: 21291510 RESULT

• Ross S, Tang S, Eliasziw M, Lier D, Girard I, Brennand E, Dederer L, Jacobs P, Robert M. Transobturator tape versus retropubic tension-free vaginal tape for stress urinary incontinence: 5-year safety and effectiveness outcomes following a randomised trial. Int Urogynecol J. 2016 Jun;27(6):879-86. doi: 10.1007/s00192-015-2902-7. Epub 2015 Dec 15.

  PMID: 26670575 RESULT

• Lier D, Robert M, Tang S, Ross S. Surgical treatment of stress urinary incontinence-trans-obturator tape compared with tension-free vaginal tape-5-year follow up: an economic evaluation. BJOG. 2017 Aug;124(9):1431-1439. doi: 10.1111/1471-0528.14227. Epub 2016 Aug 10.

  PMID: 27506185 RESULT

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

• Sue Ross, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Magali Robert, MD

  Univerty of Calgary, Calgary Health Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor, Obstetrics and Gynecology

Study Record Dates

• First Submitted: October 5, 2005
• First Posted: October 7, 2005
• Study Start: September 1, 2005
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: August 31, 2016

Record last verified: 2016-08

Locations

CA (1)