NCT03697954

Direct Full-stage Implantation of Sacral Neuromodulation

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this investigator-initiated study is to investigate the efficacy and costs of direct full stage sacral neuromodulation in patients with overactive bladder. Patients with refractory OAB and urge urinary incontinence will undergo direct full stage implantation and be followed for a period of 6 months to monitor symptom improvement with voiding diaries and validated questionnaires preoperatively and postoperatively. Therapeutic and adverse outcomes will be evaluated. The use of medical resources and time off of work will be analyzed as well. This will be a descriptive study with no additional arms or randomization.

Conditions

• Urinary Bladder, Overactive
• Urge Incontinence

Interventions

Type	Name	Description
DEVICE	full stage implantation of sacral neuromodulation	full stage implantation of sacral neuromodulation for overactive bladder and urge incontinence

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2018-10-05
• Last updated: 2020-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study