55 Participants Needed

Axonics SNM System for Overactive Bladder

Recruiting at 3 trial locations
GG
ES
Overseen ByErum Shaikh
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Axonics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and performance of the Axonics SNM System, a device designed to assist individuals with overactive bladder. Researchers aim to determine if the device maintains its effectiveness over time for those with implants. Individuals with overactive bladder who have not found success with other treatments might be suitable candidates. Participants must be prepared to visit clinical centers for follow-up assessments. As an unphased trial, this study provides a unique opportunity to contribute to the understanding of a promising treatment for overactive bladder.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Axonics SNM System is safe for overactive bladder?

Research has shown that the Axonics SNM System, used to treat overactive bladder, is safe for people. In an important study, no serious problems related to the device were reported after two years, indicating that the treatment did not cause major issues for participants during that time.

The FDA has already approved the Axonics SNM System for treating urinary problems, suggesting it is generally well-tolerated. While minor side effects can occur, data indicates that the device usually does not cause significant harm.

In summary, based on existing studies and its current use for similar conditions, the Axonics SNM System appears to be safe.12345

Why are researchers excited about this trial?

The Axonics SNM System for overactive bladder is unique because it uses sacral neuromodulation, which involves implanting a small device to regulate nerve activity. Unlike standard treatments like medications or lifestyle changes, which can have variable effectiveness and side effects, this system directly targets the nerves controlling bladder function. Researchers are excited because this approach offers a long-term solution with the potential for fewer side effects, aiming to improve quality of life for individuals with overactive bladder.

What is the effectiveness track record for the Axonics SNM System in treating overactive bladder?

Research has shown that the Axonics SNM System effectively manages overactive bladder symptoms. In one study, 89% of participants experienced significant improvements in bladder control. Another study found that 90% of individuals noticed substantial improvements within six months. Long-term data confirms its safety and effectiveness for over two years. Additionally, up to 82% of patients reported at least a 75% improvement in symptoms, with 37% becoming completely dry. These findings strongly support the Axonics SNM System's effectiveness in treating overactive bladder.678910

Who Is on the Research Team?

MP

Mahreen Pakzad, MD

Principal Investigator

University College London Hospitals

Are You a Good Fit for This Trial?

This trial is for individuals with Overactive Bladder (OAB) symptoms like urge incontinence or frequent urination, who haven't improved with basic treatments. Participants must be able to give written consent and commit to follow-up assessments at clinical centers.

Inclusion Criteria

I am willing to sign consent and can attend all follow-up visits.
I have overactive bladder symptoms that haven't improved with basic treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Axonics SNM System Model 5101 and are monitored for safety and performance

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Axonics SNM System INS Model 5101 (R20)
Trial Overview The study is evaluating the long-term safety and performance of the Axonics SNM System INS Model 5101 (R20), a device designed for urinary control in patients with OAB.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Overactive BladderExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Axonics, Inc.

Lead Sponsor

Trials
7
Recruited
820+

Citations

Axonics® System Clinical OutcomesBacked by the pivotal ARTISAN-SNM trial study and RELAX-OAB study, Axonics® is clinically proven to help people regain urinary and bowel control.
One‐year outcomes of the ARTISAN‐SNM study with ...The Axonics System is safe and effective at 1 year, with 89% of participants experiencing clinically and statistically significant improvements in UUI symptoms.
Two‐year safety and efficacy outcomes for the treatment of ...Abstract. Aims: Sacral neuromodulation (SNM) therapy for overactive bladder (OAB) has proven long‐term safety and efficacy.
6-Month Results of the ARTISAN-SNM StudyConclusions: The Axonics r-SNM System is safe and effective with 90% of participants experiencing clinically and statistically significant improvements in ...
Sacral neuromodulation for urinary incontinenceContemporary data identified symptomatic improvement to ≥ 75% in 82% of patients with a “completely dry” rate of 37%. SNM is also utilized in the management of ...
Important Safety Information (United States/Canada)Axonics SNM Therapy for urinary control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge ...
Information for Prescribers and PatientsEfficacy and adverse events of sacral nerve stimulation for overactive bladder ... Additionally, safety data for the Axonics SNM System was.
Axonics SNM System® Patient Therapy GuideAxonics SNM therapy for urinary control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge ...
PMCF Study of the Axonics SNM System Model 5101 (R20)To demonstrate an improvement in Overactive Bladder Quality of Life using the International Consultation of Incontinence Questionnaire Overactive Bladder ...
Two‐year safety and efficacy outcomes for the treatment of ...The Axonics System provides sustained clinically meaningful improvements in OAB subjects at 2 years. There were no serious device‐related AEs.
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