F15 Recharge Free Axonics SNM System Clinical Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Axonics SNM System (Model 4101): Safety and performance/effectiveness assessment of the recharge free Axonics SNM System (Model 4101 in participants with overactive bladder (OAB) or fecal incontinence (FI).

Study summary

Multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System.

Eligibility

Primary outcome measure(s)

• Performance/Effectiveness - Improvement in Quality of Life scoring (OAB) — 3 months
  International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.
• Performance/Effectiveness - Improvement in Fecal Incontinence Survey — 3 months
  Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): includes 5 items (solid, liquid, gas, wears pad and lifestyle alteration) and 5 frequencies (never = 0, rarely = 1, sometimes = 2, usually = 3, always = 4). Scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence.
• Adverse event reporting (Safety) — 3 months
  Device-related, procedure-related and all serious adverse events

Trial sites (16)