Percutaneous Tibial Nerve Stimulation Maintenance: Monthly Therapy or Per Patient Requested Need

NCT03136601 | Completed

• 1 other identifier: 30996-01
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this study is to compare the efficacy of the standard monthly maintenance therapy for percutaneous tibial nerve stimulation (PTNS), to sessions as the patient needs (prn) between 2 weeks and 12 weeks, based on overactive bladder symptoms. This is study is to help determine feasibility for conducting a larger trial that is appropriately powered to provide meaningful data.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Quality of Life - change

  The primary aim is patient reported quality of life. A validated quality of life questionnaire specific to overactive bladder (OAB) (OAB-q).

  3 months and 12 months from enrollment

Secondary Outcomes (1)

• Patient Satisfaction- change

  3 months and 12 months from enrollment

Other Outcomes (1)

• Urinary Symptoms - change

  3 months and 12 months from enrollment

Study Arms (2)

PTNS monthly

ACTIVE COMPARATOR

Patients return for PTNS maintenance monthly.

Other: PTNS maintenance

PTNS as needed

EXPERIMENTAL

Patients return for PTNS as needed (2-12 weeks).

Other: PTNS maintenance

Interventions

PTNS maintenance OTHER

The intervention is the timing of PTNS for maintenance (monthly treatment versus as patient needs)

PTNS as needed; PTNS monthly

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Urogynecology clinic setting where only female patients are seen.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be eligible if they have completed 12 session of PTNS treatment and agree to continue with maintenance therapy.
• Capable of giving informed consent, primary language of English or Spanish,
• Ambulatory and able to use toilet independently without difficulty, Capable and willing to follow all study-related procedures, OAB

You may not qualify if:

• Current urinary tract infection, Male, under 18 years old, non-English or Spanish speaking, patients who are unable to consent for themselves, prisoners, pregnant patients.

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead

Study Sites (1)

Harbor UCLA Medical Center

Torrance, California, 90509, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: May 2, 2017
• Study Start: October 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: January 20, 2026

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)