Surgical Slings for Stress Urinary Incontinence

Recruiting at 17 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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Desara® Blue Transobturator Sling for stress urinary incontinence?

Research shows that both single-incision and transobturator slings, like the Desara® Blue, are effective for treating stress urinary incontinence in women. Studies have demonstrated their safety and success in improving symptoms over the long term. ^{1 2 3 4 5}

How is the Desara® Blue Transobturator Sling treatment different from other treatments for stress urinary incontinence?

The Desara® Blue Transobturator Sling and Desara® One Single Incision Sling are unique because they use a minimally invasive approach to support the urethra, which can reduce recovery time and complications compared to traditional surgeries. These slings are designed to be more compatible with the body's tissues, potentially offering a more comfortable and effective solution for stress urinary incontinence. ^{1 4 6 7 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

References

1. United States 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. [2011]

2. United States 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. [2020]

3. Canada pubmed.ncbi.nlm.nih.gov

Transobturator sling with intraoperative cough test is effective for patients with low valsalva leak point pressure. [2009]

4. Brazil pubmed.ncbi.nlm.nih.gov

[Retropubic and transobturator sling in treatment of stress urinary incontinence]. [2019]

5. India pubmed.ncbi.nlm.nih.gov

A Comparative Evaluation of Suburethral and Transobturator Sling in 209 Cases with Stress Urinary Incontinence in 8 years. [2021]

6. India pubmed.ncbi.nlm.nih.gov

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

7. Romania pubmed.ncbi.nlm.nih.gov

[Use of slings in vaginal surgery]. [2011]

8. Canada 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. [2020]