SUI-100 Device for Stress Urinary Incontinence

(SaHARA Trial)

Recruiting at 7 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Acoustic Wave Cell Therapy, Inc.

Disqualifiers: BMI >35, Non-ambulatory, Pregnancy, Others

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

Compensation: Varies

Number of Visits: 3

Duration: 3 months

130 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You may need to keep your current medication dose the same during the trial, especially if you're taking medications for urge urinary incontinence or other drugs that affect incontinence. If you're on oral or vaginal estrogen therapy, testosterone, or certain other medications, you must have been on a stable dose for 3 months before the trial and maintain that dose throughout.

What data supports the effectiveness of the SUI-100™ treatment for stress urinary incontinence?

Research on similar treatments, like intravaginal electrical stimulation combined with pelvic floor exercises, shows a significant decrease in symptoms of stress urinary incontinence, suggesting that SUI-100™ might also be effective. ^{1 2 3 4 5}

What safety data exists for the SUI-100 device for stress urinary incontinence?

Studies have evaluated the safety of disposable intravaginal devices for stress urinary incontinence, showing they are generally safe for use in women. ^{6 7 8 9 10}

What is the purpose of this trial?

The goal of this pivotal clinical trial is to evaluate the safety and effectiveness of the SUI-100 device for the treatment of mild-to-moderate stress urinary incontinence (SUI) in females aged 22-70 years. The main questions this study aims to answer are: 1. Does treatment with the SUI-100 device reduce SUI symptoms, as measured by urine leakage. 2. Is the device safe and effective compared to the sham group? Participants will: 1. Be randomly assigned to an active or sham control group in a blinded, multicenter study. 2. Attend treatment visits during the Treatment Phase, with SUI assessments conducted at specific intervals. 3. Enter a 3-month, treatment-free follow-up phase, with SUI assessment. 4. Proceed to three monthly maintenance treatments, followed by a final SUI assessment at study exit. The total study duration will last approximately 18 months, with each individual's participation lasting approximately 6-8 months. This study aims to provide robust data on the effectiveness, safety, and durability of the SUI-100 device for treating female Stress Urinary Incontinence.

Eligibility Criteria

This trial is for women aged 22-70 with mild-to-moderate stress urinary incontinence. Participants must be able to attend multiple treatment visits and follow-up assessments over a period of 6-8 months. The study excludes specific details not provided.

Inclusion Criteria

Agrees not to participate in any other clinical research study(s) during this study

µ-24-PWT >10 grams, and ≤74 grams

Negative urine test for pregnancy

Exclusion Criteria

Subject has any electrical or electromagnetic implanted medical devices

µ-24-PWT ≥ 75 grams

PVR urine test volume >150 mL

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active or sham sessions with the SUI-100 Device, with SUI assessments conducted at specific intervals

3 months

Multiple visits (in-person)

Follow-up

Participants enter a treatment-free follow-up phase with SUI assessment

3 months

Regular assessments (in-person)

Maintenance

Participants proceed to three monthly maintenance treatments, followed by a final SUI assessment at study exit

3 months

3 visits (in-person)

Treatment Details

Interventions

• SUI-100™

Trial Overview The SUI-100 device, which uses acoustic stimulation therapy to treat stress urinary incontinence, is being tested against a sham (fake) device. Women will be randomly assigned to either the real or sham treatment in this blinded study.

Participant Groups

Group I: Crossover Active Treatment Arm Experimental Treatment 1 Intervention

Sham participants who opt to crossover after unblinding receive active sessions with the SUI-100 Device.

Group II: Active Treatment Arm Experimental Treatment 1 Intervention

Participants receive active sessions using the SUI-100 Device.

Group III: Sham Treatment Arm Placebo Group 1 Intervention

Participants receive sham sessions using the SUI-100 Device.

Who Is Running the Clinical Trial?

Acoustic Wave Cell Therapy, Inc.

Lead Sponsor

Trials

1

Recruited

130+

Findings from Research

In a study involving 60 women with severe stress urinary incontinence, 85% achieved a significant reduction of 70% or more in pad weight gain after using a novel intravaginal device for 28 days, indicating its efficacy.

The device was found to be easy to use and well-tolerated, leading to improvements in quality of life and satisfaction among users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence. Ziv, E., Stanton, SL., Abarbanel, J.[2008]

In a study of 50 women with recurrent stress urinary incontinence, the adjustable Remeex system™ showed a high objective cure rate of 90%, indicating its efficacy in treating this condition.

While the subjective cure rate was lower at 48%, the procedure significantly improved patients' quality of life, with a notable reduction in urinary incontinence impact from a median score of 10 to 2.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the Remeex system™ in Colombian women with recurrent stress urinary incontinence or intrinsic sphincter deficiency. Plata, M., Robledo, D., Bravo-Balado, A., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Accuracy and precision of the NovoPen 3 insulin delivery device after mechanical and temperature stresses. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Multicenter user evaluation of ACCU-CHEK® Combo, an integrated system for continuous subcutaneous insulin infusion. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Patients' Perception of the Use of the EasyPod™ Growth Hormone Injector Device and Impact on Injection Adherence: A Multi-Center Regional Study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Use of sensor-integrated pump therapy to reduce hypoglycaemia in people with Type 1 diabetes: a real-world study in the UK. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Treatment of urinary stress incontinence by intravaginal electrical stimulation and pelvic floor physiotherapy. [2018]

6. England pubmed.ncbi.nlm.nih.gov

75NC007 device for noninvasive stress urinary incontinence management in women: a randomized controlled trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence. [2008]

8. England pubmed.ncbi.nlm.nih.gov

Effectiveness of the Remeex system™ in Colombian women with recurrent stress urinary incontinence or intrinsic sphincter deficiency. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. [2022]