Study Summary
This trial will compare the safety and effectiveness of two types of surgical slings used to treat urinary incontinence in women.
- Stress Incontinence
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 7 Secondary · Reporting Duration: 6 weeks, 6, 12, 18, 24, 36 months
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Desara® Blue
1 of 2
Desara® One
1 of 2
Active Control
Experimental Treatment
300 Total Participants · 2 Treatment Groups
Primary Treatment: Desara® One Single Incision Sling · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · Female Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| New Mexico | 100.0% |
What site did they apply to?
| Valley Urogynecology Associates, Inc. | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Why did patients apply to this trial?
- "I am interested in having better control over my incontinence. This seems like a positive option."
What questions have other patients asked about this trial?
- "How long are the screening visits, how many visits are required. What must I do to prepare for this? Is there monetary compensation for participating?"
How many prior treatments have patients received?
| 1 | 100.0% |
Frequently Asked Questions
How pervasive is this research project in the city?
"Right now, 16 clinical trial sites are enrolling for this study. Along with Idaho Falls, Las Vegas and Franklin there are 13 other cities hosting recruitment centres. To reduce the burden of travel, it is recommended to select a location nearby when signing up for this clinical trial." - Anonymous Online Contributor
Are there vacancies in this research endeavor for participants?
"As outlined on clinicaltrials.gov, this trial is still accepting participants as of August 10th 2022. The initial posting for the study was November 1st 2021." - Anonymous Online Contributor
What are the desired outcomes of this research endeavor?
"This multi-year clinical trial will primarily evaluate the occurrence of adverse events associated with a particular medical device or procedure. Secondary assessments include composite success rates, patient impressions related to incontinence post-implant, time taken for voiding after implantation, and overall improvements in incontinence through use of the Patient Global Impression of Improvement index." - Anonymous Online Contributor
How many participants are actively taking part in this research study?
"To fulfill the requirements set out by this clinical trial, 300 patients with specific qualifications must be found. Women's Health Care Associates P.A. dba Rosemark Women Care Specialists in Idaho Falls and Women's Cancer Center of Nevada in Las Vegas are two potential sites for patient participation." - Anonymous Online Contributor