Condensed Percutaneous Tibial Nerve Stimulation (PTNS) Protocol

Not Applicable

Terminated

• Conditions: Overactive Bladder Syndrome
• Interventions: Device: percutaneous tibial nerve stimulation (PTNS); Device: Sham procedure

• Registration Number: NCT03559946
• Lead Sponsor: Stony Brook University

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-06-08
• Study First Submitted: 2018-06-08
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-18
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-10
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Protocol (SP) group	Sham procedure	The patients in the SP group will receive one PTNS treatment and one sham treatment per week for 12 weeks
Standard Protocol (SP) group	percutaneous tibial nerve stimulation (PTNS)	The patients in the SP group will receive one PTNS treatment and one sham treatment per week for 12 weeks
Condensed Protocol (CP) group	percutaneous tibial nerve stimulation (PTNS)	The patients in the CP group will receive 2 PTNS treatments per week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Global Response Assessment (GRA)	At week 6 and week 12	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stony Brook Medicine Women's Pelvic Health And Continence Center; 🇺🇸 Stony Brook, New York, United States