Surgical Slings for Stress Urinary Incontinence

Recruiting at 18 trial locations

Overseen By Sean Francis, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Caldera Medical, Inc.

Must not be taking: Anticoagulants, Opioids, Steroids

Disqualifiers: Neurological disease, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the safety and effectiveness of two surgical slings for treating stress urinary incontinence (SUI), a condition where physical movement or activity causes involuntary urine leakage. Participants will receive either the Desara® One Single Incision Sling or the Desara® Blue Transobturator Sling to determine which is more effective over 36 months. Women with stress urinary incontinence who have tried other non-surgical treatments and are ready for a surgical option may be suitable for this trial. As an unphased trial, this study allows participants to contribute to valuable research that could enhance future treatment options for SUI.

Will I have to stop taking my current medications?

The trial requires that participants stop taking anti-coagulation therapy for at least 24-48 hours before the surgery. If you are on chronic systemic steroid treatment, you may not be eligible to participate.

What prior data suggests that these surgical slings are safe for stress urinary incontinence?

Research has shown that sling procedures like the Desara® One Single Incision Sling and the Desara® Blue Transobturator Sling are generally well-tolerated. Studies on similar single incision slings have found them safe for treating stress urinary incontinence (SUI) in women.

The Desara® Blue Transobturator Sling has been in use for some time and received FDA approval, which supports its safety. Long-term studies on slings like the Desara® Blue indicate that complications are rare and manageable.

In summary, both slings have a strong safety record and are designed to help women with SUI without causing significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for stress urinary incontinence because they offer innovative approaches compared to traditional options like the mid-urethral sling. The Desara® One Single Incision Sling is unique because it requires just a single incision, potentially reducing recovery time and minimizing risks associated with surgery. Meanwhile, the Desara® Blue Transobturator Sling uses a transobturator approach, which may offer better support and fewer complications for certain patients. These advancements could make a significant difference in patient comfort and outcomes.

What evidence suggests that this trial's treatments could be effective for stress urinary incontinence?

This trial will compare the Desara® One Single Incision Sling (SIS) and the Desara® Blue Transobturator Sling for treating stress urinary incontinence (SUI). Research has shown that the Desara® One Single Incision Sling might not be as effective in curing SUI as standard mid-urethral slings. However, participants using this sling often report greater satisfaction and an improved quality of life over three years. In contrast, the Desara® Blue Transobturator Sling has proven effective for treating SUI, with many individuals experiencing a short-term cure. Both treatments aim to support the urethra (the tube that carries urine out of the bladder) and help reduce accidental leakage. When considering these options, weigh the benefits of improved quality of life against differences in cure rates. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for women over 18 with stress urinary incontinence who've tried non-surgical treatments without success. They must not be pregnant, have finished childbearing, and be able to attend follow-up visits. Exclusions include previous pelvic radiation therapy, polypropylene allergy, significant pelvic pain or neurological diseases affecting bladder control.

Inclusion Criteria

I have been diagnosed with stress urinary incontinence.

I have tried or decided against non-surgical treatments for SUI and chosen surgery.

You have more trouble with leaking urine when you cough or sneeze than with a sudden, strong urge to go to the bathroom.

Exclusion Criteria

You have had a bad reaction or allergy to polypropylene.

I experience pelvic pain at a level of 2 or higher on a scale of 10.

I have had radiation treatment to my pelvic area before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Desara® One Single Incision Sling or Desara® Blue Sling for the treatment of stress urinary incontinence

6 weeks

1 visit (in-person) for implantation

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits

36 months

Follow-up visits at 2 and 6 weeks, 6, 12, 18, 24, and 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Desara® Blue Transobturator Sling
• Desara® One Single Incision Sling

Trial Overview The study compares the Desara® One Single Incision Sling (SIS) to an FDA-approved transobturator sling for treating urinary incontinence over three years. It aims to assess which method is safer and more effective.

How Is the Trial Designed?

Group I: Desara® One Experimental Treatment 1 Intervention

Single Incision Sling

Group II: Desara® Blue Active Control 1 Intervention

Transobturator Sling

Desara® Blue Transobturator Sling is already approved in United States for the following indications:

Approved in United States as Desara Blue Transobturator Sling for:

• Genuine Stress Urinary Incontinence (SUI)
• Mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency

Who Is Running the Clinical Trial?

Caldera Medical, Inc.

Lead Sponsor

Trials

1

Recruited

300+

Published Research Related to This Trial

In a study of 209 women with stress urinary incontinence, the transobturator Monarc sling showed a very low complication rate (less than 1%) and a success rate of 95%, making it a safe and effective option for treatment.

The suburethral TVT sling had a higher complication rate but still achieved a success rate of 94.5%. Additionally, the Indian-designed Trivedi's sling was significantly more cost-effective, costing only 15-20% of international brands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Evaluation of Suburethral and Transobturator Sling in 209 Cases with Stress Urinary Incontinence in 8 years. Trivedi, P., D'Costa, S., Shirkande, P., et al.[2021]

In a long-term follow-up study of 94 patients treated for stress urinary incontinence, both the transobturator sling (TVT-O) and single-incision sling (TVT-S) showed similar objective cure and subjective satisfaction rates after 10 years.

However, the TVT-O group maintained a higher success rate over the decade, with no decline in effectiveness, while the TVT-S group experienced a significant drop in success rates, indicating that TVT-O may be a more reliable option for long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of outcomes between single-incision sling and transobturator sling for treating stress urinary incontinence: A 10-year prospective study. Sun, Z., Wang, X., Lang, J., et al.[2020]

In a study of 30 women with stress urinary incontinence, both retropubic and transobturator sling surgeries showed significant improvements in incontinence and quality of life after 12 months, with high cure rates of 84.2% and 88.8%, respectively.

Both surgical techniques demonstrated similar efficacy and low complication rates, indicating that either method is a safe and effective option for treating female stress urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Retropubic and transobturator sling in treatment of stress urinary incontinence]. Tanuri, AL., Feldner, PC., Bella, ZI., et al.[2019]

In a study of 1,398 women with stress urinary incontinence, the single incision sling (SECUR) showed similar effectiveness to traditional retropubic and transobturator slings, with a low rate of positive cough stress tests (15.8% for SECUR compared to 12.8% for retropubic and 3.6% for transobturator).

The SECUR sling had advantages such as shorter operative time, fewer overnight hospital stays, and a quicker return to normal activities, making it a convenient option that can be performed under local anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The TVT Worldwide Observational Registry for Long-Term Data: safety and efficacy of suburethral sling insertion approaches for stress urinary incontinence in women. Tincello, DG., Botha, T., Grier, D., et al.[2011]

The transobturator sling (TOS) is effective for treating female stress urinary incontinence (SUI), showing a subjective cure rate of 94% in patients with low valsalva leak point pressure (VLPP), which indicates intrinsic sphincter deficiency (ISD).

There was no significant difference in cure rates between patients with low VLPP (94%) and those with higher VLPP (84%), suggesting that TOS can be a suitable option for women with SUI and ISD, especially when combined with intraoperative adjustments for optimal tensioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transobturator sling with intraoperative cough test is effective for patients with low valsalva leak point pressure. Anast, JW., Skolarus, TA., Yan, Y., et al.[2009]

The transobturator tape (TOT) procedure for treating stress urinary incontinence (SUI) showed a high success rate of 93.2% in a study of 59 female patients followed for 6 months.

Most patients (86.4%) reported complete satisfaction with the results, and the procedure had minimal complications, suggesting it could become the new gold standard for SUI treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transobturator Tape in Treatment of Stress Urinary Incontinence: It is Time for a New Gold Standard. Magon, N., Chopra, SV.[2022]

In a study of 128 patients with stress urinary incontinence, all three sling types (Composix, TVT, and TVT-O) showed significant long-term improvements in continence, as measured by a 24-hour pad test, with average pad weights dropping from 30.4 g preoperatively to 5 g at 12 months.

While the Composix sling was cost-effective and provided similar continence outcomes, it was associated with a higher rate of minor complications and secondary procedures compared to the other sling types, raising concerns about its safety for future use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An in-house Composix™-based pubovaginal sling trial for female stress urinary incontinence: Five-year comparative followup to tension-free and transobturator vaginal tapes. Ben-Zvi, T., Moore, K., Haidar, N., et al.[2020]

The use of slings for treating genital prolapse and urinary stress incontinence is supported by their effectiveness in reducing relapse rates compared to traditional surgical methods, particularly in patients with poor connective tissue quality.

Several sling techniques, including Tension-free Vaginal Tape (TVT) and Trans-obturator Tape (TOT), are recommended based on specific conditions like cystocele and rectocele, highlighting the importance of tailored approaches in surgical treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of slings in vaginal surgery]. Socolov, D., Socolov, RV.[2011]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04772131?term=William+Oh

Desara ® One Single Incision Sling 522 Study This study will enroll adult females who are clinically indicated for a mid-urethral implant for the treatment of female stress urinary incontinence (SUI) ...

2. clinicaltrial.be clinicaltrial.be/en/details/47092?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Desara ® One Single Incision Sling 522 Study 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 ...

3. ctv.veeva.com ctv.veeva.com/study/desara-r-one-single-incision-sling-522-study

Desara ® One Single Incision Sling 522 Study 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12152813/

Evaluation of the efficacy of mini-sling in the treatment ... The C-NDL procedure is a safe and effective method with few complications and high subjective cure rates on short-term follow-up (6 months).

5. medicaldevice-network.com medicaldevice-network.com/projects/caldera-medicals-desara-tvez-transvaginal-sling-system-us/

Caldera Medical's Desara TVez Transvaginal Sling ... Desara TVez is a transvaginal sling system for the treatment of female stress urinary incontinence (SUI). The device improves physicians' flexibility.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12496164/

Long-term safety of mid-urethral sling for stress urinary ... This is the first study reporting real-life data on long-term complications of MUS from all synthetic MUS implantations, TVT or TOT, performed ...

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?t_id=374&c_id=5964

522 Postmarket Surveillance Studies Database - FDA Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of Desara One single incision sling compared to Desara Blue Sling System implanted via TOR for ...