Stress Urinary IncontinenceNCT04772131
Desara ® One Single Incision Sling 522 Study
A study testing Desara® One Single Incision Sling and Desara® Blue Transobturator Sling in people with Stress Urinary Incontinence, run by Caldera Medical, Inc. at 15 sites in United States.
Trial summary
A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months. 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?
- Desara® One Single Incision Sling and Desara® Blue Transobturator Sling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 15 sitesUnited States
- Study dates
- 1 Nov 2021to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Female ≥ 18 of age.
- Subject agrees that she is willing and able to return for all study related procedures and evaluations.
- Subject has provided signed informed consent.
- Subject has stress urinary incontinence (SUI) confirmed by either supine or standing cough stress test (CST) with bladder pre-fill to subjective fullness with 200-300 mL, or with bladder fullness confirmed via ultrasound.
- Subject has confirmed stress incontinence greater than urge incontinence per MESA questionnaire.
- Subject no longer has childbearing capacity or has a negative pregnancy test and has decided to cease childbearing. Childbearing capacity to be confirmed by documented history of:
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- A hysterectomy or
- Tubal ligation or
- Is otherwise incapable of pregnancy or has
- Negative pregnancy test prior to study entry and has decided to cease childbearing
- Subject has been offered and either failed or refused alternative non-invasive SUI treatment options and has elected to proceed with a surgical intervention.
- Subject is eligible to undergo laparoscopic/robotic (with or without mesh) or vaginal (with or without mesh) apical, anterior or posterior prolapse concomitant surgical repair procedures (non-mesh).
Who cannot join
- Subject reports baseline pelvic pain ≥ 2 on 10 point Numeric Rating Scale (NRS).
- Subject has a known neurological disease (with or without signs/symptoms of neurogenic bladder).
- Subject has known pre-existing pain syndrome and/or has been evaluated by an interventional pain management physician.
- Subject has a history of chronic opioid, or narcotic use for:
- pain or
- any other specified reason
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- Subject is on anti-coagulation therapy that cannot be suspended or adjusted for a minimum of 24-48 hours prior to planned sling implantation surgery.
- Subject is on chronic (> 3 months) systemic steroid treatment (except for inhalational use as indicated for pulmonary conditions).
- Subject has uncontrolled diabetes defined as A1c ≥ 7% or fasting serum glucose > 130mg/dl at screening/baseline.
- Subject has an active lesion or skin infection of the perineum, urethra, or vagina as noted per visual pelvic exam.
- Subject has active UTI which requires treatment, as determined by the Investigator.
- Subject has pattern of recurrent UTIs, defined as ≥ 3 culture-proven UTIs during the 6-month period prior to surgery.
- Subject has a urethral obstruction or other anatomic defects of the urethra (inclusive of urethral diverticulum or stricture or bladder neck contracture).
- The subject has had:
- any prior surgical stress urinary incontinence treatment or
- any prior surgery on their urethra or
- any prior surgery to distal anterior vaginal wall, including fistula repair or prior cystocele repair
- any previous pelvic floor mesh use or complication
- Subject has any of the following confounding conditions:
- bladder stones or tumors
- pathology that in the opinion of the Investigator would compromise implant placement
- pathology that would limit pelvic blood supply
- pathology that would require chemotherapy and systemic use of immunosuppressants
- Subject has abnormal bladder capacity <300 mL.
- Subject has a post void residual volume ≥ 150 mL on two different measurements. (Prolapse reduction during PVR measurement is only allowed if a prolapse repair will be performed concomitantly with the sling implantation)
- Subject has had previous radiation therapy or brachytherapy to the pelvis.
- Subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function, interfere with clinical outcomes, or impact analysis of this device.
- Subject has known reaction, sensitivity or allergy to polypropylene.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Mt. Auburn Hospital Division of Urogynecology
Cambridge, Massachusetts, 02138
Novant Health Urogynecology
Charlotte, North Carolina, 28210
The Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, 45219
Center for Pelvic Health
Franklin, Tennessee, 37067
Urological Research Center Corp
Hialeah, Florida, 33016
Women's Health Care Associates P.A. dba Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404
Center for Total Women's Health
Lansdale, Pennsylvania, 19446
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169
University of Louisville
Louisville, Kentucky, 40202
CMB Research, LLC
Newburgh, Indiana, 47630
Valley Urogynecology Associates, Inc.
Phoenix, Arizona, 85016
University of Washington Medical Center
Seattle, Washington, 98195
Specialty Clinical Research of St. Louis, LLC
St Louis, Missouri, 631471
University of Arizona College of Medicine
Tucson, Arizona, 85724
About this study
Official title: Prospective, Post-market Study of the Desara® One Single Incision Sling vs. Desara® Blue Sling Implanted Via the Transobturator Route for the Treatment of Women With Stress Urinary Incontinence
A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.
Read the detailed description
This study is a prospective, non-randomized, parallel cohort, multi-center study of Desara® One single incision sling (SIS) compared to Desara® Blue sling systems implanted via the transobturator-route (TOR) for the treatment of women with stress urinary incontinence (SUI). The study will compare results from SIS patients (N=150) and TOR patients (N=150) at up to 40 sites for a total period of 36 months, with follow-up visits at 2 and 6 weeks, 6, 12, 18, 24 and 36 months. This study will enroll adult females who are clinically indicated for a mid-urethral implant for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
- Conditions
- Stress Urinary Incontinence
- Being tested
- Desara® One Single Incision Sling, Desara® Blue Transobturator Sling
- Keywords
- stress urinary incontinence, female stress urinary incontinence, single incision sling, transobturator sling, Desara® One, Desara® Blue
- 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.
Desara® One Single Incision SlingDevice
Single incision sling
Desara® Blue Transobturator SlingDevice
Standard mid-urethral sling
| Study group | Role | What they receive |
|---|---|---|
| Desara® One | Experimental | Single Incision Sling Receives: Device: Desara® One Single Incision Sling |
| Desara® Blue | Active comparator | Transobturator Sling Receives: Device: Desara® Blue Transobturator Sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of negative standing cough stress test (CST)
Negative standing cough stress test (CST) with bladder pre-fill to subjective fullness with 200-300 mL, or with bladder fullness confirmed via ultrasound, evaluated at the 36-month post-implant follow-up visit. The success rate is defined as the proportion of subjects with a negative CST at the 36-month post-implant follow-up
Measured: 36 months
Device and Procedure-related serious adverse events
- Device- and/or procedure-related adverse event rates at the post-implant follow-up visits
- Revision/re-surgery rates at post-implant follow-up visits
- Device and/or procedure-related serious adverse events
Measured: 36 months
Secondary outcomes (7)
Composite outcome success rates
Defined by the primary effectiveness endpoint and subjective measure of Improvement in the Patient Global Impression of Improvement (PGI-I) index for incontinence post-implant
Measured: 6 weeks, 6, 12, 18, 24, 36 months
Sexual Function Assessment
Use of PISQ-12: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire to assess subject changes in sexual function
Measured: 6 weeks, 6, 12, 18, 24, 36 months
Improvement in Incontinence
Use of PGI-I: Patients Global Impression of Improvement index for incontinence to assess subject improvement post-implant
Measured: 6 weeks, 6, 12, 18, 24, 36 months
Improvement in Urinary Symptoms
Use of IIQ-7: Incontinence Impact Questionnaire, Short Form and ICIQ-UI: International Consultation on Incontinence Questionnaire-Urinary Incontinence to assess improvement in urinary symptoms post-implant
Measured: 6 weeks, 6, 12, 18, 24, 36 months
Improvement in Urge and Stress Incontinence
Use of UDI-6 SF: Urinary Distress Inventory, Short Form to assess subject improvement in urge and stress incontinence post-implant
Measured: 6 weeks, 6, 12, 18, 24, 36 months
Subject pain assessment
Use of Numeric Rating 10-point scale (NRS) to assess post-operative pain. Pain scale is 0= no pain to 10 = worst pain
Measured: 6 weeks, 6, 12, 18, 24, 36 months
Time to void post-implant
Perform a standard post void residual test to confirm that the subject's residual urine volume is ≥150 mL
Measured: 6 weeks, 6, 12, 18, 24, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Nov 2021
- Primary completion7 Aug 2026
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Adult female subjects, who in the opinion of their physician require surgical treatment or who have already been diagnosed with stress urinary incontinence, will be eligible for study participation. Subjects who provide informed consent will undergo screening and baseline assessments. Subjects who successfully meet the study's inclusion and exclusion criteria will be eligible to undergo a Desara SIS or Desara Blue implant procedure, with subsequent follow-up assessments. The choice of implant, Desara One or Desara Blue, will be determined by the investigator based upon patient pathology and surgical preference.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caldera Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772131
- Sponsor's protocol ID
- PS200005
- Status last verified
- Aug 2026
- First submitted
- 5 Feb 2021
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Post-market Study of the Desara® One Single Incision Sling vs. Desara® Blue Sling Implanted Via the Transobturator Route for the Treatment of Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04772131
- Acronym / sponsor ID
- PS200005
- Conditions
- Stress Urinary Incontinence
- Keywords
- stress urinary incontinence, female stress urinary incontinence, single incision sling, transobturator sling, Desara® One, Desara® Blue
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Caldera Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 7 Aug 2026 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 26 Feb 2021 (actual)
- 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.
A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.
Detailed description
This study is a prospective, non-randomized, parallel cohort, multi-center study of Desara® One single incision sling (SIS) compared to Desara® Blue sling systems implanted via the transobturator-route (TOR) for the treatment of women with stress urinary incontinence (SUI). The study will compare results from SIS patients (N=150) and TOR patients (N=150) at up to 40 sites for a total period of 36 months, with follow-up visits at 2 and 6 weeks, 6, 12, 18, 24 and 36 months. This study will enroll adult females who are clinically indicated for a mid-urethral implant for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Adult female subjects, who in the opinion of their physician require surgical treatment or who have already been diagnosed with stress urinary incontinence, will be eligible for study participation. Subjects who provide informed consent will undergo screening and baseline assessments. Subjects who successfully meet the study's inclusion and exclusion criteria will be eligible to undergo a Desara SIS or Desara Blue implant procedure, with subsequent follow-up assessments. The choice of implant, Desara One or Desara Blue, will be determined by the investigator based upon patient pathology and surgical preference.
| Arm | Type | Receives |
|---|---|---|
| Desara® One | Experimental | Device: Desara® One Single Incision SlingSingle Incision Sling |
| Desara® Blue | Active comparator | Device: Desara® Blue Transobturator SlingTransobturator Sling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female ≥ 18 of age.
- Subject agrees that she is willing and able to return for all study related procedures and evaluations.
- Subject has provided signed informed consent.
- Subject has stress urinary incontinence (SUI) confirmed by either supine or standing cough stress test (CST) with bladder pre-fill to subjective fullness with 200-300 mL, or with bladder fullness confirmed via ultrasound.
- Subject has confirmed stress incontinence greater than urge incontinence per MESA questionnaire.
Key exclusion criteria (28 listed)
- Subject reports baseline pelvic pain ≥ 2 on 10 point Numeric Rating Scale (NRS).
- Subject has a known neurological disease (with or without signs/symptoms of neurogenic bladder).
- Subject has known pre-existing pain syndrome and/or has been evaluated by an interventional pain management physician.
- Subject has a history of chronic opioid, or narcotic use for:
- Subject is on anti-coagulation therapy that cannot be suspended or adjusted for a minimum of 24-48 hours prior to planned sling implantation surgery.
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 |
|---|---|---|
| Desara® One Single Incision SlingSingle incision sling | Device | Desara® One |
| Desara® Blue Transobturator SlingStandard mid-urethral sling | Device | Desara® Blue |
Primary outcome
Success rate of negative standing cough stress test (CST)
Time frame: 36 months
Negative standing cough stress test (CST) with bladder pre-fill to subjective fullness with 200-300 mL, or with bladder fullness confirmed via ultrasound, evaluated at the 36-month post-implant follow-up visit. The success rate is defined as the proportion of subjects with a negative CST at the 36-month post-implant follow-up
Device and Procedure-related serious adverse events
Time frame: 36 months
* Device- and/or procedure-related adverse event rates at the post-implant follow-up visits * Revision/re-surgery rates at post-implant follow-up visits * Device and/or procedure-related serious adverse events
7 secondary outcomes
Composite outcome success rates
Time frame: 6 weeks, 6, 12, 18, 24, 36 months
Sexual Function Assessment
Time frame: 6 weeks, 6, 12, 18, 24, 36 months
Improvement in Incontinence
Time frame: 6 weeks, 6, 12, 18, 24, 36 months
Improvement in Urinary Symptoms
Time frame: 6 weeks, 6, 12, 18, 24, 36 months
Improvement in Urge and Stress Incontinence
Time frame: 6 weeks, 6, 12, 18, 24, 36 months
Subject pain assessment
Time frame: 6 weeks, 6, 12, 18, 24, 36 months
Time to void post-implant
Time frame: 6 weeks, 6, 12, 18, 24, 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desara® One Single Incision Sling and Desara® Blue Transobturator Sling in people with Stress Urinary Incontinence, run by Caldera Medical, Inc. at 15 sites in United States.
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 12 inclusion and 28 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Success rate of negative standing cough stress test (CST) (time frame: 36 months). 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?
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 13 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.