Effects of Transcutaneous and Percutaneous PTNS on Idiopathic OAB

Effects of Transcutaneous and Percutaneous Posterior Tibial Nerve Stimulation on Idiopathic Overactive Bladder Syndrome: Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Overactive Detrusor; Urge Incontinence
• Intervention / Treatment: Device: TENS SNS; Device: PTNS

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08024
    • Inés Ramírez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcutaneous Tibial Nerve Stimulation; 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.	Device: TENS SNS; Electrodes are connected to a low voltage (9 V) electrical stimulator (URO stim2). Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 msec is increased until flexion of the big toe or fanning of all toes becomes visible, or until the subject reports a tingling sensation across the heel or bottom of the foot.; Other Names: Transcutaneous Tibial Nerve Stimulation (URO stim2)
Active Comparator: Percutaneous Tibial Nerve Stimulation; 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.	Device: PTNS; The needle and electrode are connected to a low voltage (9 V) electrical stimulator (URO stim2). Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 msec is increased until flexion of the big toe or fanning of all toes becomes visible, or until the subject reports a tingling sensation across the heel or bottom of the foot.; Other Names: Percutaneous Tibial Nerve Stimulation (URO stim2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction from Baseline in Urinary Frequency Scores on 3-day voiding diaries at 12 weeks	A reduction in urinary frequency was regarded clinically significant when a normal voiding pattern of less than 8 voids per 24 hours could be obtained	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction from Baseline in the number of leakage episodes diaries at 6 weeks and at 12 weeks	A reduction in the number of leakage episodes of at least 30% on 3-day voiding was regarded significant	6 and 12 weeks
Change from Baseline in Mean, Moderate to Severe Urgency episodes on 3-day voiding diaries at 6 and at 12 weeks	A reduction in number of urgency episodes at 6 weeks and 12 weeks	6 and 12 weeks
Reduction from Baseline in Mean Nocturia Episodes on 3-day voiding diaries at 6 and at 12 weeks	A reduction of at least 25% was regarded significant	6 and 12 weeks
Improved quality of life function via the Incontinence Quality of Life Scale (I-QOL)	An improvement of at least 10 points was regarded significant	6 and 12 weeks
Improved Bladder Symptom Severity Score via Overactive Bladder Questionnaire (OAB-q) at 6 and at 12 weeks	An improvement of at least 10 points was regarded significant	6 and 12 weeks
Degree of Satisfaction Score on the Treatment Benefit Scale (TBS) at 6 and at 12 weeks	A score of 1 or 2 was regarded significant	6 and 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that request for continuous chronic treatment to keep the obtained response after receiving 12 PTNS/TENS sessions for OAB complaints	A number of at least 50% was regarded significant	12 weeks
Number of complaints OR adverse effects registered during treatments	complaints and side effects were registered	From Baseline to week 12

Collaborators and Investigators

• Sponsor: Instituto Médico Tecnológico SL
• Collaborators: University Ramon Llull
• Investigators: Principal Investigator: Inés Ramírez, MSc, Instituto Médico Tecnológico

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: December 20, 2015
• First Submitted That Met QC Criteria: January 13, 2016
• First Posted (Estimate): January 15, 2016

Study Record Updates

• Last Update Posted (Actual): August 21, 2017
• Last Update Submitted That Met QC Criteria: August 16, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: neuromodulation; percutaneous; OAB; transcutaneous; electrical estimulation
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge
• Other Study ID Numbers: IMT46681770