Effects of Transcutaneous and Percutaneous PTNS on Idiopathic OAB

Instituto Médico Tecnológico SL

Status: Completed

Conditions: Overactive Detrusor; Urge Incontinence; Overactive Bladder

Treatments: Device: PTNS; Device: TENS SNS

Study type: Interventional

Funder types: Other

Identifiers

NCT02657057

IMT46681770

Details and patient eligibility

About

The purpose of this study is to determine if Transcutaneous Tibial Nerve Stimulation (TENS) is as effective as Percutaneous Tibial Nerve Stimulation (PTNS) as therapeutic option for subjects with Idiopathic Overactive Bladder (OAB) who have failed conventional therapy.

Full description

Both therapies have been proven to be effective, but very few times have been compared. PTNS and TENS SNS have been proven effective modifying bladder diary scores (change in the frequency of day and night urination, and urge incontinence), and improving subject's quality of life. Only PTNS has shown changes in urodynamic data while undergoing therapy.

The investigators hypothesize that short-term effectiveness and benefit reported, is not lower in the TENS group, if we compare both therapies in a randomized control trial.

Secondary goals are to evaluate changes in bladder diary scores (frequency of urination, nocturia, number of urgency and leakage episodes ), participants quality of life improvement scores and treatment benefit score at TBS scale, while undergoing these therapies.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female and male
• Age >18 years
• Complaint urge urinary incontinence (3 or more episodes per week) OR overactive bladder (8 or more voids per day, and/or 2 or more voids per night)
• Urodynamic data of overactive detrusor
• Failed trial of conservative therapy (bladder training, fluid modification, diet modification, caffeine restriction, pelvic floor training)
• Failed trial of anticholinergic either due to inability to take the medication, adverse reaction to medication, or no improvement on medication
• Willing to complete study questionnaires and informed consent study

Exclusion criteria

• Presence of bladder obstruction (prostate or prolapse)
• Neurogenic bladder overactivity
• Previous pelvic organ prolapse surgery
• Unwilling and mentally incompetent to participate in study
• Pregnancy or planning to become pregnant during the study
• Presence of urinary fistula
• Recurrent or current urinary tract infection (5 or more infections in the last 12 months)
• Bladder stones
• Bladder cancer or suspected bladder cancer
• Hematuria
• Central or peripheral neurologic disorders such as Multiple Sclerosis, Parkinson's disease, spina bifida, or other spinal cord lesion
• Metal implants such as pacemaker, implantable defibrillator, or metal implants where PTNS or TENS device needs to be placed (sacrum or ankle/leg).
• Uncontrolled diabetes and diabetes with peripheral nerve involvement
• Anticoagulants treatment
• Current use of anticholinergics or use within the last 4 weeks
• Current use of botox bladder injections or bladder botox injection within the last year
• Current use of interstim therapy or currently implanted interstim device or leads
• Urinary retention or gastric retention
• Painful Bladder Syndrome/Interstitial Cystitis
• Previous PTNS treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Transcutaneous Tibial Nerve Stimulation

Experimental group

Description:

TENS SNS therapy is performed as follows; patient is asked to sit with legs slightly bent and an adhesive electrode is attached transcutaneously 5cm cephalic to either the right or left medial malleolus (subject choice). A surface electrode is placed on the medial surface of the ipsilateral calcaneum and both electrodes are connected to a low voltage electronic stimulator. The current is then set to the highest level tolerable to the subject (0-20 mA) and subject undergoes therapy for 30 minutes and 12 weeks (once-a-week session). Data are completed at baseline, after half therapy and after 12 weeks therapy.

Treatment:

Device: TENS SNS

Percutaneous Tibial Nerve Stimulation

Active Comparator group

Description:

PTNS therapy is performed as follows; patient is asked to sit with legs slightly bent. The area where the needle will be placed is cleaned with an alcohol swab. A 34 gauge needle (equivalent to an acupuncture needle) is inserted percutaneously approximately 5 cm cephalad to the medial malleolus of the right or left ankle (subject choice) at a 60 degree angle. A surface electrode is placed on the medial surface of the ipsilateral calcaneous. The needle and electrode are connected to a low voltage electrical stimulator. The current is then set to the highest level tolerable to the subject (0-20 mA) and the subject undergoes therapy for 30 minutes and 12 weeks (once-a-week session). Data are completed at baseline, after half therapy and after 12 weeks therapy.

Treatment:

Device: PTNS