Desara® One Single Incision Sling for Stress Incontinence

Institute for Female Pelvic Medicine, Knoxville, TN
Stress IncontinenceDesara® One Single Incision Sling - Device

Study Summary

This trial will compare the safety and effectiveness of two types of surgical slings used to treat urinary incontinence in women.

Eligible Conditions
  • Stress Incontinence

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: 6 weeks, 6, 12, 18, 24, 36 months

36 months
Device and Procedure-related serious adverse events
Month 36
Composite outcome success rates
Improvement in Incontinence
Improvement in Urge and Stress Incontinence
Improvement in Urinary Symptoms
Sexual Function Assessment
Subject pain assessment
Time to void post-implant

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

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

Desara® One
Experimental Group · 1 Intervention: Desara® One Single Incision Sling · Intervention Types: Device
Desara® Blue
ActiveComparator Group · 1 Intervention: Desara® Blue Transobturator Sling · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks, 6, 12, 18, 24, 36 months

Who is running the clinical trial?

Caldera Medical, Inc.Lead Sponsor

Eligibility Criteria

Age 18+ · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You experience more stress-related bladder leakage than sudden urges to urinate, according to a specific questionnaire called MESA.

Who else is applying?

What state do they live in?
New Mexico100.0%
What site did they apply to?
Valley Urogynecology Associates, Inc.100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
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?

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

Unverified Answer

Are there vacancies in this research endeavor for participants?

"As outlined on, this trial is still accepting participants as of August 10th 2022. The initial posting for the study was November 1st 2021." - Anonymous Online Contributor

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.