Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234754
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2005-10-05
Brief Title:
Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Surgical Management of Stress Urinary Incontinence in Women A Randomized Clinical Trial RCT of TOT vs TVT
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 200400964 | None | None | None |