Condensed Percutaneous Tibial Nerve Stimulation (PTNS) Protocol

NCT03559946 | Terminated FDA Device

• 1 other identifier: 1180838
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder Syndrome

Keywords

Overactive Bladder Syndrome; Percutaneous Tibial Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incontinence impact questionnaire-7 (IIQ-7)

  At week 0, 6 and 12

Other Outcomes (1)

• Urinary Distress Inventory (UDI) 6 short form

  At week 0, 6 and 12

Study Arms (2)

Standard Protocol (SP) group

SHAM COMPARATOR

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); Device: Sham procedure

Condensed Protocol (CP) group

EXPERIMENTAL

The patients in the CP group will receive 2 PTNS treatments per week for 12 weeks.

Device: percutaneous tibial nerve stimulation (PTNS)

Interventions

percutaneous tibial nerve stimulation (PTNS) DEVICE

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.

Condensed Protocol (CP) group; Standard Protocol (SP) group

Sham procedure DEVICE

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

Standard Protocol (SP) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and men (18 years of age and older) with overactive bladder syndrome, who are interested in receiving PTNS treatment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stony Brook University: lead
• Laborie Medical Technologies Inc.: collaborator

Study Sites (1)

Stony Brook Medicine Women's Pelvic Health And Continence Center

Stony Brook, New York, 11733, United States

Location

Related Publications (2)

• Peters KM, Carrico DJ, Perez-Marrero RA, Khan AU, Wooldridge LS, Davis GL, Macdiarmid SA. Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010 Apr;183(4):1438-43. doi: 10.1016/j.juro.2009.12.036. Epub 2010 Feb 20.

  PMID: 20171677 BACKGROUND

• Finazzi-Agro E, Petta F, Sciobica F, Pasqualetti P, Musco S, Bove P. Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: a randomized, double-blind, placebo controlled trial. J Urol. 2010 Nov;184(5):2001-6. doi: 10.1016/j.juro.2010.06.113. Epub 2010 Sep 20.

  PMID: 20850833 BACKGROUND

Study Officials

• Jason Kim, M.D.

  Stony Brook University Hospital, Department of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients in both CP and SP groups will come to the clinic twice per week, and will not know their group assignment until the end of the study. All the interventions will be performed by the sub-investigator. The care providing physician will not know the group assignment of the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Urology

Model Details: 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.

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: June 18, 2018
• Study Start: June 8, 2018
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)