Condensed Percutaneous Tibial Nerve Stimulation (PTNS) Protocol

Study Overview
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Brief Summary
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The purpose of this study is to understand how the frequency of PTNS sessions impacts their efficacy in the treatment of over active bladder syndrome.

Detailed Description
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This study aims to evaluate the impact of the periodicity of the PTNS treatments on the efficacy of treating patients with OAB. We will compare the efficacy of a condensed (twice weekly) protocol to the standard (once per week) protocol of PTNS therapy. Objective #1 (6-wk CP vs. 12-wk SP) is to show that 6 weeks of the condensed protocol (CP) will yield a higher efficacy compared to the standard 12-week protocol (SP). If this 6-week CP is proven effective, candidates for PTNS treatment could potentially experience symptom relief in half the time as the current standard of care, improving their quality of life quicker. Objective #2 (12-wk CP vs. 12-wk SP) is to show that 12 weeks of the CP will have a higher efficacy compared to the 12-week SP. If the superiority of this 12-week CP is proven, it could be beneficial in treating patients with refractory OAB.

Official Title
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A Randomized Controlled Trial Comparing the Efficacy of a Condensed (Twice Weekly) Protocol to the Standard (Once Per Week) Protocol of Percutaneous Tibial Nerve Stimulation (PTNS) in the Treatment of Overactive Bladder Syndrome (OAB)

Conditions
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Overactive Bladder Syndrome

Intervention / Treatment
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* Device: percutaneous tibial nerve stimulation (PTNS)
* Device: Sham procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women and men (18 years of age and older) with overactive bladder syndrome, who are interested in receiving PTNS treatment. Exclusion Criteria: Patients with anatomical limitations preventing successful placement of the electrode, medical disorders precluding stimulation (bleeding disorders, cardiac pacemakers, peripheral vascular disease or ulcers, or lower leg cellulitis). Pregnant women or women who are planning to become pregnant during the course of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We will be recruiting 66 patients, who will be randomized (1:1) to either the Standard Protocol (SP) group or the Condensed Protocol (CP) group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Standard Protocol (SP) group<br>The patients in the SP group will receive one PTNS treatment and one sham treatment per week for 12 weeks | Device: percutaneous tibial nerve stimulation (PTNS)<br>* The PTNS and the sham treatments will be given in 30 min sessions. The PTNS treatment consists of inserting a 34-gauge needle electrode approximately 5 cm cephalad to the medial malleolus and, as well as placing a PTNS surface electrode on the ipsilateral calcaneus. To keep the electrode placement consistent with the sham treatment, 2 inactive transcutaneous electrical nerve stimulation (TENS) surface electrodes are also added, 1 placed under the little toe and 1 on the top of the foot. The PTNS lead set is connected to the Urgent PC stimulator, and a current level of 0.5 to 10 mA at 20 Hz is delivered until the flexion of the big toe is observed or the patient reports a radiating sensation at the sole of the foot.<br>Device: Sham procedure<br>* The sham treatment, involves simulating the sensation of the PTNS needle insertion at the same location using a Steritberger placebo needle. This is a blunt tip needle which simulates the sensation of a needle prick when touched to the skin, however, the blunt tip retracts into the handle when pressed into the skin. This creates the illusion of the needle entering the skin, without breaking the skin's surface. An inactive PTNS surface electrode is also placed on the ipsilateral calcaneus. The two TENS surface electrodes, placed in the same location as the PTNS treatment, are active and deliver stimulation mimicking the sensory effects of the PTNS. However, since no electrode needles were inserted near the tibial nerve, there will be no tibial nerve stimulation<br>|
| Experimental: Condensed Protocol (CP) group<br>The patients in the CP group will receive 2 PTNS treatments per week for 12 weeks. | Device: percutaneous tibial nerve stimulation (PTNS)<br>* The PTNS and the sham treatments will be given in 30 min sessions. The PTNS treatment consists of inserting a 34-gauge needle electrode approximately 5 cm cephalad to the medial malleolus and, as well as placing a PTNS surface electrode on the ipsilateral calcaneus. To keep the electrode placement consistent with the sham treatment, 2 inactive transcutaneous electrical nerve stimulation (TENS) surface electrodes are also added, 1 placed under the little toe and 1 on the top of the foot. The PTNS lead set is connected to the Urgent PC stimulator, and a current level of 0.5 to 10 mA at 20 Hz is delivered until the flexion of the big toe is observed or the patient reports a radiating sensation at the sole of the foot.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Response Assessment (GRA) | GRA asks the patents to rate how their urinary symptoms have changed since the start of the treatment on a 7-point scale (markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, and markedly improved) | At week 6 and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incontinence impact questionnaire-7 (IIQ-7) | IIQ-7 contains 7 questions to assess how accidental urine loss has affected the patients' activities, relationships, and feelings. | At week 0, 6 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder Syndrome, Percutaneous Tibial Nerve Stimulation