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Effects of Transcutaneous and Percutaneous PTNS on Idiopathic OAB

Primary Purpose

Overactive Bladder, Urge Incontinence, Overactive Detrusor

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PTNS
TENS SNS
Sponsored by
Instituto Médico Tecnológico SL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring neuromodulation, electrical estimulation, percutaneous, transcutaneous, OAB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Inés Ramírez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transcutaneous Tibial Nerve Stimulation

Percutaneous Tibial Nerve Stimulation

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Improved quality of life function via the Incontinence Quality of Life Scale (I-QOL)
An improvement of at least 10 points was regarded significant
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
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

Full Information

First Posted
December 20, 2015
Last Updated
August 16, 2017
Sponsor
Instituto Médico Tecnológico SL
Collaborators
University Ramon Llull
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1. Study Identification

Unique Protocol Identification Number
NCT02657057
Brief Title
Effects of Transcutaneous and Percutaneous PTNS on Idiopathic OAB
Official Title
Effects of Transcutaneous and Percutaneous Posterior Tibial Nerve Stimulation on Idiopathic Overactive Bladder Syndrome: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Médico Tecnológico SL
Collaborators
University Ramon Llull

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urge Incontinence, Overactive Detrusor
Keywords
neuromodulation, electrical estimulation, percutaneous, transcutaneous, OAB

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous Tibial Nerve Stimulation
Arm Type
Experimental
Arm 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.
Arm Title
Percutaneous Tibial Nerve Stimulation
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
PTNS
Other Intervention Name(s)
Percutaneous Tibial Nerve Stimulation (URO stim2)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
TENS SNS
Other Intervention Name(s)
Transcutaneous Tibial Nerve Stimulation (URO stim2)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction from Baseline in Urinary Frequency Scores on 3-day voiding diaries at 12 weeks
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Reduction from Baseline in the number of leakage episodes diaries at 6 weeks and at 12 weeks
Description
A reduction in the number of leakage episodes of at least 30% on 3-day voiding was regarded significant
Time Frame
6 and 12 weeks
Title
Change from Baseline in Mean, Moderate to Severe Urgency episodes on 3-day voiding diaries at 6 and at 12 weeks
Description
A reduction in number of urgency episodes at 6 weeks and 12 weeks
Time Frame
6 and 12 weeks
Title
Reduction from Baseline in Mean Nocturia Episodes on 3-day voiding diaries at 6 and at 12 weeks
Description
A reduction of at least 25% was regarded significant
Time Frame
6 and 12 weeks
Title
Improved quality of life function via the Incontinence Quality of Life Scale (I-QOL)
Description
An improvement of at least 10 points was regarded significant
Time Frame
6 and 12 weeks
Title
Improved Bladder Symptom Severity Score via Overactive Bladder Questionnaire (OAB-q) at 6 and at 12 weeks
Description
An improvement of at least 10 points was regarded significant
Time Frame
6 and 12 weeks
Title
Degree of Satisfaction Score on the Treatment Benefit Scale (TBS) at 6 and at 12 weeks
Description
A score of 1 or 2 was regarded significant
Time Frame
6 and 12 weeks
Other Pre-specified Outcome Measures:
Title
Number of participants that request for continuous chronic treatment to keep the obtained response after receiving 12 PTNS/TENS sessions for OAB complaints
Description
A number of at least 50% was regarded significant
Time Frame
12 weeks
Title
Number of complaints OR adverse effects registered during treatments
Description
complaints and side effects were registered
Time Frame
From Baseline to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inés Ramírez, MSc
Organizational Affiliation
Instituto Médico Tecnológico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inés Ramírez
City
Barcelona
ZIP/Postal Code
08024
Country
Spain

12. IPD Sharing Statement

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Effects of Transcutaneous and Percutaneous PTNS on Idiopathic OAB

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