NCT01029106

Brief Summary

This is a prospective, non-randomized, observational, multicentre (5 sites) study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a TVT SECUR operative procedure. The study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires, Intraoperative procedural data will be collected. Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals up to 24 months. The anatomic position of the device will be characterize by transvaginal ultrasound testing. To determine the rate and/or improvement rate of patients who have received the Gynecare Secur device after 12 months and after 24 months.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Last Updated

July 28, 2011

Status Verified

July 1, 2011

Enrollment Period

3 years

First QC Date

October 19, 2009

Last Update Submit

July 27, 2011

Conditions

Stress Urinary Incontinence

Keywords

SUIStress Urinary IncontinencePatients with Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • The primary endpoints are the cure/improvement rate in the cohort at 12 months.

    12 months

Secondary Outcomes (5)

  • Distribution of percentage of subjects having a decrease of pad weight as compared to baseline

    24 months

  • Decrease in number of pads used within a 24-hour period as compared to baseline

    24 months

  • Change in patient questionnaires from baseline

    24 months

  • Change in the sling position on transvaginal ultrasound

    24 months

  • Cure/improvement rate at 24 months

    24 months

Interventions

Gynecare TVT SecurPROCEDURE

Implant of the Gynecare TVT Secur

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Approximately 125 women with SUI from 5 centres across Canada will participate in this study.

You may qualify if:

  • To be considered eligible to participate in this study, subjects must meet the following requirements:
  • Subject has agreed to undergo surgical implantation of the TVT SECUR System
  • Subject has the complaint of SUI for at least 6 months prior to the Preoperative Evaluation Visit.
  • Subject has confirmed SUI resulting from urethral hypermobility on cough stress testing.
  • Subject has at least 4 gm of urine leakage on 1-hour pad testing during the Preoperative Screening Visit.
  • Subject is at least 18 years of age to maximum of 85 years of age
  • Subject is willing and able to give written informed consent prior to any study related procedures.
  • Subject is willing to return for follow-up evaluation and questionnaire completion at 4-6 weeks, and at 3, 6, 12 and 24 month follow-ups.
  • Subject is willing to undergo transvaginal ultrasound evaluation at the 4 weeks and 12 month follow-up visit.

You may not qualify if:

  • Subjects will not be eligible for entry into the study if they meet one of the following criteria:
  • Subject is pregnant.
  • Subject has had any previous synthetic sub-urethral sling procedure.
  • Subject has current urinary tract or vaginal infections.
  • Subject has blood coagulation disorders.
  • Subject has a compromised immune system or any other conditions that would compromise healing.
  • Subject has upper urinary tract obstruction.
  • Subject is unwilling to provide written informed consent.
  • Subject is unwilling or unable to return for evaluation at 4-6 weeks, and at 3, 6, 12, and 24 months.
  • Subject has uncontrolled detrusor overactivity.
  • Subject has PVR greater than 100 cc.
  • Subject has Peak Flow Rate less than 10 ml/sec.
  • Subject has urethral diverticulum.
  • Subject has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
  • Subject has had radiation therapy to the pelvic area at any time.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sender Herschorn, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 19, 2009

First Posted

December 9, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2012

Last Updated

July 28, 2011

Record last verified: 2011-07

Locations

CA(1)