Home Versus Office Removal of Percutaneous Nerve Evaluation (PNE) Lead

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT05799313
Status
Recruiting
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Conditions

  • Overactive Bladder

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • At home removal — OTHER
    Removal of PNE lead at home
  • In office removal — OTHER
    Removal of PNE lead in the office

Study Details

For women undergoing percutaneous nerve evaluation (PNE) for the treatment of overactive bladder the first step is the PNE interstim therapy trial. If the PNE works, patients may opt to have the interstim procedure. The purpose of this study is to see if patients who remove their PNE lead at home have the same satisfaction with the PNE trial as those women who have their lead removed in the office.

Key Dates

Start date
Jun 7, 2023
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: At home removal
  • Active Comparator: In office removal

Primary Outcome Measure

Patient satisfaction between at home versus in office PNE lead removal [ Time Frame: 3-7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Research Line
216-445-8090
Marie Fidela R. Paraiso, M.D. (SUB_INVESTIGATOR)
Shannon Wallace, M.D. (SUB_INVESTIGATOR)

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