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

Stress Urinary Incontinence Clinical Trial

Official title:

Surgical Management of Stress Urinary Incontinence in Women: A Randomized Clinical Trial (RCT) of TOT vs TVT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234754
• Other study ID #: 18421
• Secondary ID: 200400964
• Status: Completed
• Phase: N/A
• First received: October 5, 2005
• Last updated: August 29, 2016
• Start date: September 2005
• Est. completion date: October 2013

Study information

• Verified date: August 2016
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a randomized trial in which women with stress incontinence will be allocated to receive either TOT or TVT procedures. Women who elect surgical management of their type II stress incontinence are eligible to participate in the trial. Baseline data, including a patient questionnaire, will be collected. Hospital outcomes, including length of stay and surgical complications will be documented from hospital charts. All women attend a 6-week follow-up visit as standard of care: a structured data collection form will be used by surgeons to collect information and another patient questionnaire will be administered. At 12 months postoperatively women will attend the clinic for objective measurement of incontinence, a full exam and to complete a questionnaire. The main outcome is effectiveness of the procedure determined using a 1-hour pad test. Secondary research questions include:

How effective is TOT compared to TVT in terms of:

Subjective cure at 12 months postoperatively? Incontinence-specific quality of life at 6 weeks and 12 months postoperatively? Satisfaction with surgery at 12 months postoperatively? Return to usual activities and usual sex life after surgery? The prevalence of voiding dysfunction at 12 months postoperatively? Surgical complications, both short term and long term? Utility and cost? (an economic evaluation) The study will be carried out according to the ICH Good Clinical Practice Guidelines.

At 5 years postoperatively women will attend the clinic for a further follow-up. The primary research question of the 5-year follow-up is:

Safety - What is the incidence of vaginal erosion or other serious adverse outcomes of surgery among women who had a surgical procedure for stress urinary incontinence utilizing a TOT device, versus a TVT device, over the 5 years following surgery?

Secondary questions are as follows:

Effectiveness - What are the objective and subjective outcomes of TOT compared with TVT at 5 years following surgery for SUI? Health economics - What are the disease-specific rates of health service utilization related to repeat surgical intervention, as well as surgery and other treatment related to adverse events for women who had a TOT procedure, versus those who had a TVT procedure, over the 5 years after surgery? Using economic modelling and cost utility analysis, is TOT cost-effective compared with TVT over the 5 years after surgery?

Other question:

Do women with tape found to be palpable in the vagina at 12 months postoperatively, go on to develop vaginal erosion by 5 years following surgery?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women with type II stress incontinence, defined as leaking with increased abdominal pressure

• Are eligible for both types of surgery

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• TVT Surgery TOT Surgery
TVT surgery and TOT surgery

Locations

Country	Name	City	State
Canada	Calgary Health Region	Calgary	Alberta

Sponsors (5)

Lead Sponsor	Collaborator
University of Calgary	Alberta Health Services, Alberta Heritage Foundation for Medical Research, Boston Scientific Corporation, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. 2016 Aug 10. doi: 10.1111/1471-0528.14227. [Epub ahead of prin — View Citation

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) — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Vaginal erosion or other serious adverse outcomes of surgery over 5 years postoperatively		5 years	Yes
Secondary	How effective is TOT compared to TVT in terms of subjective cure 12 months postoperatively?		1 year	No
Secondary	Incontinence-specific quality of life at 6 weeks and 12 months postoperatively?		1 year	No
Secondary	Satisfaction with surgery at 12 months postoperatively?		1 year	No
Secondary	Return to usual activities and usual sex life after surgery?		6 weeks and 1 year	No
Secondary	The prevalence of voiding dysfunction at 12 months postoperatively?		1 year	No
Secondary	Surgical complications, both short term and long term?		6 weeks and 1 year	Yes
Secondary	Utility and cost? (an economic evaluation)		1 year	No
Secondary	Subjective effectiveness at 5 years postoperatively		5 years	No
Secondary	Incontinence-specific quality of life at 5 years postoperatively	Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)	5 years	No
Secondary	Health care utilization over 5 years postoperatively		5 year	No
Secondary	Cost effectiveness over 5 years postoperatively		5 year	No
Secondary	Objective effectiveness at 5 years postoperatively	Pad test leakage of <1g over period of test	5 years	No