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Direct Full-stage Implantation of Sacral Neuromodulation

NCT03697954 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2020-10-14

No results posted yet for this study

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

DEVICE

full stage implantation of sacral neuromodulation

full stage implantation of sacral neuromodulation for overactive bladder and urge incontinence

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-31
Primary Completion
2022-12-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03697954 on ClinicalTrials.gov