Effects of Transcutaneous and Percutaneous PTNS on Idiopathic OAB

NCT02657057 | Completed

• 1 other identifier: IMT46681770
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overactive Bladder; Urge Incontinence; Overactive Detrusor

Keywords

neuromodulation; electrical estimulation; percutaneous; transcutaneous; OAB

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Reduction from Baseline in the number of leakage episodes diaries at 6 weeks and at 12 weeks

  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

  6 and 12 weeks

• Reduction from Baseline in Mean Nocturia Episodes on 3-day voiding diaries at 6 and at 12 weeks

  6 and 12 weeks

• Improved quality of life function via the Incontinence Quality of Life Scale (I-QOL)

  6 and 12 weeks

• Improved Bladder Symptom Severity Score via Overactive Bladder Questionnaire (OAB-q) at 6 and at 12 weeks

  6 and 12 weeks

Other Outcomes (2)

• Number of participants that request for continuous chronic treatment to keep the obtained response after receiving 12 PTNS/TENS sessions for OAB complaints

  12 weeks

• Number of complaints OR adverse effects registered during treatments

  From Baseline to week 12

Study Arms (2)

Transcutaneous Tibial Nerve Stimulation

EXPERIMENTAL

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

Percutaneous Tibial Nerve Stimulation

ACTIVE COMPARATOR

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

Interventions

PTNS DEVICE

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.

Also known as: Percutaneous Tibial Nerve Stimulation (URO stim2)

Percutaneous Tibial Nerve Stimulation

TENS SNS DEVICE

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.

Also known as: Transcutaneous Tibial Nerve Stimulation (URO stim2)

Transcutaneous Tibial Nerve Stimulation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Médico Tecnológico SL: lead
• University Ramon Llull: collaborator

Study Sites (1)

Inés Ramírez

Barcelona, 08024, Spain

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Study Officials

• Inés Ramírez, MSc

  Instituto Médico Tecnológico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, MSc

Study Record Dates

• First Submitted: December 20, 2015
• First Posted: January 15, 2016
• Study Start: November 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 21, 2017

Record last verified: 2017-08

Locations

ES (1)