Stress Urinary IncontinenceNCT00234754
Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women
A study testing TVT Surgery TOT Surgery in people with Stress Urinary Incontinence, run by University of Calgary at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- TVT Surgery TOT Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with type II stress incontinence, defined as leaking with increased abdominal pressure
- Are eligible for both types of surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Management of Stress Urinary Incontinence in Women: A Randomized Clinical Trial (RCT) of TOT vs TVT
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.
Read the detailed 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?
- Conditions
- Stress Urinary Incontinence
- Being tested
- TVT Surgery TOT Surgery
- Keywords
- Incontinence, Surgery, Trans-vaginal tape, Trans-obturator tape
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVT Surgery TOT SurgeryProcedure or surgery
TVT surgery and TOT surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Trans-vaginal tape Surgery Receives: Procedure: TVT Surgery TOT Surgery |
| 2 | Experimental | Trans-obturator tape surgery Receives: Procedure: TVT Surgery TOT Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Vaginal erosion or other serious adverse outcomes of surgery over 5 years postoperatively
Measured: 5 years
Secondary outcomes (12)
How effective is TOT compared to TVT in terms of subjective cure 12 months postoperatively?
Measured: 1 year
Incontinence-specific quality of life at 6 weeks and 12 months postoperatively?
Measured: 1 year
Satisfaction with surgery at 12 months postoperatively?
Measured: 1 year
Return to usual activities and usual sex life after surgery?
Measured: 6 weeks and 1 year
The prevalence of voiding dysfunction at 12 months postoperatively?
Measured: 1 year
Surgical complications, both short term and long term?
Measured: 6 weeks and 1 year
Utility and cost? (an economic evaluation)
Measured: 1 year
Subjective effectiveness at 5 years postoperatively
Measured: 5 years
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)
Measured: 5 years
Health care utilization over 5 years postoperatively
Measured: 5 year
Cost effectiveness over 5 years postoperatively
Measured: 5 year
Objective effectiveness at 5 years postoperatively
Pad test leakage of <1g over period of test
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2005 (estimated)
- Study startSep 2005
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Alberta Health services, Boston Scientific Corporation, Alberta Heritage Foundation for Medical Research
- Responsible party
- Principal investigator, Dr. Sue Ross, University of Calgary
- Investigators
- Sue Ross, PhD, Principal investigator, University of CalgaryMagali Robert, MD, Principal investigator, Univerty of Calgary, Calgary Health Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234754
- Sponsor's protocol ID
- 18421
- Other IDs
- 200400964
- Status last verified
- Aug 2016
- First submitted
- 5 Oct 2005
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Decision to share will depend on review of IPD protocol
Publications
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.
PubMed 21781314Ross 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.
PubMed 19935032Lier 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.
PubMed 21291510Ross 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.
PubMed 26670575Lier 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.
PubMed 27506185
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Management of Stress Urinary Incontinence in Women: A Randomized Clinical Trial (RCT) of TOT vs TVT
- ClinicalTrials.gov ID
- NCT00234754
- Acronym / sponsor ID
- 18421
- Conditions
- Stress Urinary Incontinence
- Keywords
- Incontinence, Surgery, Trans-vaginal tape, Trans-obturator tape
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Alberta Health services, Boston Scientific Corporation, Alberta Heritage Foundation for Medical Research
- Study start
- Sep 2005
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: TVT Surgery TOT SurgeryTrans-vaginal tape Surgery |
| 2 | Experimental | Procedure: TVT Surgery TOT SurgeryTrans-obturator tape surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with type II stress incontinence, defined as leaking with increased abdominal pressure
- Are eligible for both types of surgery
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TVT Surgery TOT SurgeryTVT surgery and TOT surgery | Procedure or surgery | 1, 2 |
Primary outcome
How effective is TOT compared to TVT in terms of objective cure at 12 months postoperatively?
Time frame: 1 year
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.
Vaginal erosion or other serious adverse outcomes of surgery over 5 years postoperatively
Time frame: 5 years
12 secondary outcomes
How effective is TOT compared to TVT in terms of subjective cure 12 months postoperatively?
Time frame: 1 year
Incontinence-specific quality of life at 6 weeks and 12 months postoperatively?
Time frame: 1 year
Satisfaction with surgery at 12 months postoperatively?
Time frame: 1 year
Return to usual activities and usual sex life after surgery?
Time frame: 6 weeks and 1 year
The prevalence of voiding dysfunction at 12 months postoperatively?
Time frame: 1 year
Surgical complications, both short term and long term?
Time frame: 6 weeks and 1 year
Utility and cost? (an economic evaluation)
Time frame: 1 year
Subjective effectiveness at 5 years postoperatively
Time frame: 5 years
Incontinence-specific quality of life at 5 years postoperatively
Time frame: 5 years
Health care utilization over 5 years postoperatively
Time frame: 5 year
Cost effectiveness over 5 years postoperatively
Time frame: 5 year
Objective effectiveness at 5 years postoperatively
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Background: PubMed 21781314Ross 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.
- Results publication: PubMed 19935032Ross 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.
- Results publication: PubMed 21291510Lier 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.
- Results publication: PubMed 26670575Ross 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.
- Results publication: PubMed 27506185Lier 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.
- Individual participant dataSharing planned: Undecided. Decision to share will depend on review of IPD protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sue Ross, PhD principal investigator
University of Calgary
Magali Robert, MD principal investigator
Univerty of Calgary, Calgary Health Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TVT Surgery TOT Surgery in people with Stress Urinary Incontinence, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
How effective is TOT compared to TVT in terms of objective cure at 12 months postoperatively? (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00234754, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016.