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

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.

Study Overview

• Status: Unknown
• Conditions: Overactive Bladder
• Intervention / Treatment: Other: PTNS maintenance

Detailed Description

Patient will be recruited from the Urogynecology clinic on the first floor of the hospital. Patients who have completed 12 weeks of PTNS therapy will be identified by the clinic nurse or nurse practitioner and then a member of the research team will approach the patient regarding involvement in the study. Patients will be asked if they would like to take part in this study and will be given the human bill of rights and well as consent forms in their preferred language (English or Spanish) if they agree to participate. Once they agree to participate, they will be asked to sign the consent forms in a private patient room.

This is a pilot study for feasibility designed as an equivalence and cost analysis study. Patients will be recruited at the 12th session of PTNS (conclusion of treatment and before maintenance therapy starts).

Patients will be from the Urogynecology clinic at Harbor UCLA Medical Center who have OAB and who have been treated with the standard 12 sessions of PTNS. Patients will be randomized to "every month PTNS maintenance" or "as needed PTNS maintenance (Q2-12 weeks)." At enrollment, questions will be read to patients in either Spanish or English based on patient's preferred language and study staff will fill out the surveys for the patient. The patient with the study staff will complete the validated questionnaires, Overactive Bladder Questionnaire (OAB-q), the Benefit, Satisfaction and Willingness to Continue the Treatment questionnaire (BSW) and the Visual analogue scale for satisfaction with treatment. Urinary symptoms will be measured by the validated Overactive Bladder Symptom Scale (OAB-SS) and a modified voiding diary. All patients will have a urine dip completed at this visit to rule out a bladder infection. Finally patients, with the help of study staff, will answer open ended questions. All of these measures will be repeated 3 months after enrollment and one year from enrollment. After the yearlong study, participants can continue treatment which will be decided by the patient and treating clinician. A cost analysis will compare the cost to patients and the cost to the clinic between the monthly PTNS maintenance group and the patient prn maintenance group. All of the above measures will be recorded at enrollment, 3 months from enrollment and 1 year from enrollment. This will be done in person with the help of the study staff at enrollment and either in person, via the phone or in writing at 3 month and 1 year follow up. No payment and no other recruitment methods will be used.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90509
      • Recruiting
      • Harbor Ucla Medical Center
      • Contact: Tajnoos Yazdany, MD; Phone Number: 310-222-3868; Email: tjazdany@dhs.lacounty.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients will be eligible if they have completed 12 session of PTNS treatment and agree to continue with maintenance therapy.
• Inclusion criteria is Women >=18 years of age, Completed 12 weeks of PTNS and desire to continue,
• 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

Exclusion Criteria:

• Exclusion criteria includes Botox® use in bladder or pelvic floor muscles within past one year,
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PTNS monthly; Patients return for PTNS maintenance monthly.	Other: PTNS maintenance; The intervention is the timing of PTNS for maintenance (monthly treatment versus as patient needs)
Experimental: PTNS as needed; Patients return for PTNS as needed (2-12 weeks).	Other: PTNS maintenance; The intervention is the timing of PTNS for maintenance (monthly treatment versus as patient needs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction- change	The secondary aim is patient satisfaction which will be measured by the validated questionnaire, Benefit, Satisfaction and Willingness to Continue the Treatment questionnaire (BSW).	3 months and 12 months from enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Symptoms - change	The tertiary aim is urinary symptoms which will be measured by the validated Overactive Bladder Symptom Scale (OAB-SS).	3 months and 12 months from enrollment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): May 2, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: 30996-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No