130 Participants Needed

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.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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
See 10 more

Exclusion Criteria

Subject has any electrical or electromagnetic implanted medical devices
µ-24-PWT ≥ 75 grams
PVR urine test volume >150 mL
See 20 more

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
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Crossover Active Treatment ArmExperimental Treatment1 Intervention
Sham participants who opt to crossover after unblinding receive active sessions with the SUI-100 Device.
Group II: Active Treatment ArmExperimental Treatment1 Intervention
Participants receive active sessions using the SUI-100 Device.
Group III: Sham Treatment ArmPlacebo Group1 Intervention
Participants receive sham sessions using the SUI-100 Device.

Find a Clinic Near You

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.
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.
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

Accuracy and precision of the NovoPen 3 insulin delivery device after mechanical and temperature stresses. [2021]
Multicenter user evaluation of ACCU-CHEK® Combo, an integrated system for continuous subcutaneous insulin infusion. [2022]
Patients' Perception of the Use of the EasyPod™ Growth Hormone Injector Device and Impact on Injection Adherence: A Multi-Center Regional Study. [2022]
Use of sensor-integrated pump therapy to reduce hypoglycaemia in people with Type 1 diabetes: a real-world study in the UK. [2022]
Treatment of urinary stress incontinence by intravaginal electrical stimulation and pelvic floor physiotherapy. [2018]
75NC007 device for noninvasive stress urinary incontinence management in women: a randomized controlled trial. [2021]
Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence. [2008]
Effectiveness of the Remeex system™ in Colombian women with recurrent stress urinary incontinence or intrinsic sphincter deficiency. [2019]
Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence. [2022]
Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. [2022]
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