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Efficacy of Transcutaneous Versus Percutaneous Posterior Tibial Nerve Stimulation in the Overactive Bladder.

Primary Purpose

Overactive Bladder Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Transcutaneous tibial nerve stimulation
Percutaneous tibial nerve stimulation
Sponsored by
Fisiocore LC,SL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder Syndrome focused on measuring urgency, incontinence, nocturia, frequency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects diagnosis of overactive bladder
  • Subjects refractory to treatments antimuscarinic or beta 3-agonist
  • Subjects who do not take restricted medication
  • Subjects who can cognitively complete the voiding diary and questionnaires
  • Subject with symptoms 3 months ago
  • Men must be discarded obstruction by benign prostatic hyperplasia

Exclusion Criteria:

  • Subjects with stress incontinence
  • Subjects with urinary tract infection
  • Subjects with neurological disease
  • Subjects with pacemakers fitted
  • Pregnancy
  • Subjects who have disorder sensitive
  • A history of pelvic tumors
  • Subject who is not able to understand the physiotherapist

Sites / Locations

  • Laura Calzado SanzRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A: Transcutaneous tibial nerve stimulation

B: Percutaneous tibial nerve stimulation

Arm Description

The transcutaneous electrostimulation of the posterior tibial nerve (ETNTP) will be applied to group A: place two surface electrodes, one 32 mm in diameter, 5 cm cephalad of the internal malleolus and 1 cm medial posterior of the tibia; and another 50x50 mm electrode in the calcaneous. The flexion of the first toe will indicate the correct placement of the electrodes. Stimulation is performed according to the Stoller method with a stimulator programmed at 20Hz and 200 µs, with a continuous current, 12 sessions, 2 weekly are completed. The intensity of the current will be tolerance by the subject.

The percutaneous electrostimulation of the posterior tibial nerve (EPNTP) will be applied to group B: inserting a 0.25x30mm surgical steel needle at a 60º angle, 5 cm cephalad to the malleolus and 1 cm posterior of the tibia , and a surface electrode of 50x50 mm in the calcaneous. The flexion of the first finger will indicate its correct placement. The stimulation parameters will also follow the Stoller method.

Outcomes

Primary Outcome Measures

Urinary frequency
Urinary episodes per day. According to international consensus, it is considered pathological when: There are more than 8 episodes of urination per day
Nightime voids
Urinary episodes per night. According to international consensus, it is considered pathological when: There is more than 1 episode per night.
Urge episodes
Urinary urge episodes per day. The degree of urgency is measured through the PPIUS scale (outcome no. 4). A grade 3-4 on the PPIUS scale is considered pathological.
Degree of urge to void
Measured through the PPIUS (Patient Perception of Intensity of Urgency Scale). Scale from 0 to 4, where: 0 = No urgency; = Slight urgency; = Moderate urgency; = severe urgency; = urge incontinence.
Voided volume
Urine 24 hours volume. Voiding volume over 3000cc in 24 hours, is considered pathological.

Secondary Outcome Measures

Overactive Bladder questionnaire Short- Form (OABq-SF)
This is a questionnaire that evaluates both the symptoms and the quality of life of the patient: Symptom involvement (6 questions): Score of 6-36 Quality of life (13 questions): Score of 13-78 0-100 metric scale. The higher the score, the more severity.
International Consultation on Incontinence Questionnaire (ICIQ-SF)
This is a self-administered questionnaire that identifies people with urine incontinence (UI) and also assess the impact on quality of life. ICIQ-SF Score: Adding the scores to questions 1+2+3, a score above zero is considered a diagnosis of UI.
Benefits, satisfaction and willingness to continue to treatment (BSW)
The BSD12 questionnaire is a 3 item likert-type questionnaire (benefit, satisfaction and willingness) with an overall score of 0 to 10. Higher scores indicates a better perception of benefit and satisfaction with the treatment, and a greater willingness to continue with it.

Full Information

First Posted
March 27, 2020
Last Updated
August 8, 2022
Sponsor
Fisiocore LC,SL
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1. Study Identification

Unique Protocol Identification Number
NCT04483817
Brief Title
Efficacy of Transcutaneous Versus Percutaneous Posterior Tibial Nerve Stimulation in the Overactive Bladder.
Official Title
Efficacy of Transcutaneous Versus Percutaneous Posterior Tibial Nerve Stimulation in the Treatment of Overactive Bladder. Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2019 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisiocore LC,SL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main aim of this study, is compare the effectiveness of transcutaneous posterior tibial nerve stimulation versus percutaneous posterior nerve stimulation in patients with overactive bladder.
Detailed Description
Overactive bladder syndrome (OAB) is a set of symptoms characterized by urge, with or without urge incontinence, usually with frequency and nocturia in the absence of urinary infection or other pathologies. OAB affect considerably the quality of life of the subject who suffer. The first line of treatment is a conservative management as behavioral interventions, followed by pharmacological management as antimuscarinic or antimuscarinic drugs. Percutaneous tibial nerve stimulation (PTNS) is present as another alternative of treatment. Previous studies have shown the positive effects of PTNS in a reduction on OAB symptoms. The PTNS was described by Stoller in 1999. It's a electrical stimulation of the tibial nerve, inserting a 34 gauge needle at a 60º angle, 5 cm cephalad to the malleolus and 1 cm posterior of the tibia, to stimulation of the sacral segments S2 and S3, where the spinal centre of bladder is located. The parameters used are 20Hz and 200 µs, 12 sessions, two weekly, 30 min treatment. The PTNS is a minimal invasive technique, but can be utilized surface electrodes instead of needle to minimize the discomfort of prick. The main aim of this study, is compare the effectiveness of transcutaneous posterior tibial nerve stimulation versus percutaneous posterior nerve stimulation in patients with overactive bladder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome
Keywords
urgency, incontinence, nocturia, frequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective interventional study
Masking
Investigator
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: Transcutaneous tibial nerve stimulation
Arm Type
Experimental
Arm Description
The transcutaneous electrostimulation of the posterior tibial nerve (ETNTP) will be applied to group A: place two surface electrodes, one 32 mm in diameter, 5 cm cephalad of the internal malleolus and 1 cm medial posterior of the tibia; and another 50x50 mm electrode in the calcaneous. The flexion of the first toe will indicate the correct placement of the electrodes. Stimulation is performed according to the Stoller method with a stimulator programmed at 20Hz and 200 µs, with a continuous current, 12 sessions, 2 weekly are completed. The intensity of the current will be tolerance by the subject.
Arm Title
B: Percutaneous tibial nerve stimulation
Arm Type
Active Comparator
Arm Description
The percutaneous electrostimulation of the posterior tibial nerve (EPNTP) will be applied to group B: inserting a 0.25x30mm surgical steel needle at a 60º angle, 5 cm cephalad to the malleolus and 1 cm posterior of the tibia , and a surface electrode of 50x50 mm in the calcaneous. The flexion of the first finger will indicate its correct placement. The stimulation parameters will also follow the Stoller method.
Intervention Type
Device
Intervention Name(s)
Transcutaneous tibial nerve stimulation
Intervention Description
Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.
Intervention Type
Device
Intervention Name(s)
Percutaneous tibial nerve stimulation
Intervention Description
Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.
Primary Outcome Measure Information:
Title
Urinary frequency
Description
Urinary episodes per day. According to international consensus, it is considered pathological when: There are more than 8 episodes of urination per day
Time Frame
two years
Title
Nightime voids
Description
Urinary episodes per night. According to international consensus, it is considered pathological when: There is more than 1 episode per night.
Time Frame
two years
Title
Urge episodes
Description
Urinary urge episodes per day. The degree of urgency is measured through the PPIUS scale (outcome no. 4). A grade 3-4 on the PPIUS scale is considered pathological.
Time Frame
two years
Title
Degree of urge to void
Description
Measured through the PPIUS (Patient Perception of Intensity of Urgency Scale). Scale from 0 to 4, where: 0 = No urgency; = Slight urgency; = Moderate urgency; = severe urgency; = urge incontinence.
Time Frame
two years
Title
Voided volume
Description
Urine 24 hours volume. Voiding volume over 3000cc in 24 hours, is considered pathological.
Time Frame
two years
Secondary Outcome Measure Information:
Title
Overactive Bladder questionnaire Short- Form (OABq-SF)
Description
This is a questionnaire that evaluates both the symptoms and the quality of life of the patient: Symptom involvement (6 questions): Score of 6-36 Quality of life (13 questions): Score of 13-78 0-100 metric scale. The higher the score, the more severity.
Time Frame
Two years
Title
International Consultation on Incontinence Questionnaire (ICIQ-SF)
Description
This is a self-administered questionnaire that identifies people with urine incontinence (UI) and also assess the impact on quality of life. ICIQ-SF Score: Adding the scores to questions 1+2+3, a score above zero is considered a diagnosis of UI.
Time Frame
Two years
Title
Benefits, satisfaction and willingness to continue to treatment (BSW)
Description
The BSD12 questionnaire is a 3 item likert-type questionnaire (benefit, satisfaction and willingness) with an overall score of 0 to 10. Higher scores indicates a better perception of benefit and satisfaction with the treatment, and a greater willingness to continue with it.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects diagnosis of overactive bladder Subjects refractory to treatments antimuscarinic or beta 3-agonist Subjects who do not take restricted medication Subjects who can cognitively complete the voiding diary and questionnaires Subject with symptoms 3 months ago Men must be discarded obstruction by benign prostatic hyperplasia Exclusion Criteria: Subjects with stress incontinence Subjects with urinary tract infection Subjects with neurological disease Subjects with pacemakers fitted Pregnancy Subjects who have disorder sensitive A history of pelvic tumors Subject who is not able to understand the physiotherapist
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Calzado Sanz, Physiotherap
Phone
+34 626495479
Email
lauracalzado@lcfisioterapia.com
First Name & Middle Initial & Last Name or Official Title & Degree
María Torres Lacomba, Physiotherap
Phone
+34 678900061
Email
maria.torres@uah.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Calzado Sanz, Physiotherap
Organizational Affiliation
Fisiocore LC,SL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laura Calzado Sanz
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28806
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26586384
Citation
Wibisono E, Rahardjo HE. Effectiveness of Short Term Percutaneous Tibial Nerve Stimulation for Non-neurogenic Overactive Bladder Syndrome in Adults: A Meta-analysis. Acta Med Indones. 2015 Jul;47(3):188-200.
Results Reference
background
PubMed Identifier
20590544
Citation
Yoong W, Ridout AE, Damodaram M, Dadswell R. Neuromodulative treatment with percutaneous tibial nerve stimulation for intractable detrusor instability: outcomes following a shortened 6-week protocol. BJU Int. 2010 Dec;106(11):1673-6. doi: 10.1111/j.1464-410X.2010.09461.x.
Results Reference
result
PubMed Identifier
21092997
Citation
Civic D, Black E. Re: Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial: K. M. Peters, D. J. Carrico, R. A. Perez-Marrero, A. U. Khan, L. S. Wooldridge, G. L. Davis and S. A. MacDiarmid J Urol 2010; 183: 1438-1443. J Urol. 2011 Jan;185(1):362; author reply 362-4. doi: 10.1016/j.juro.2010.09.030. Epub 2010 Nov 18. No abstract available.
Results Reference
result
PubMed Identifier
20567947
Citation
Sajadi KP, Goldman HB. Percutaneous tibial nerve stimulation and overactive bladder. Curr Urol Rep. 2010 Sep;11(5):293-5. doi: 10.1007/s11934-010-0126-4. No abstract available.
Results Reference
result
PubMed Identifier
28731583
Citation
Booth J, Connelly L, Dickson S, Duncan F, Lawrence M. The effectiveness of transcutaneous tibial nerve stimulation (TTNS) for adults with overactive bladder syndrome: A systematic review. Neurourol Urodyn. 2018 Feb;37(2):528-541. doi: 10.1002/nau.23351. Epub 2017 Jul 21.
Results Reference
result
PubMed Identifier
22581511
Citation
Burton C, Sajja A, Latthe PM. Effectiveness of percutaneous posterior tibial nerve stimulation for overactive bladder: a systematic review and meta-analysis. Neurourol Urodyn. 2012 Nov;31(8):1206-16. doi: 10.1002/nau.22251. Epub 2012 May 11.
Results Reference
result
Links:
URL
http://uroweb.org/guidelines/
Description
Guidelines of urology´s treatments
URL
http://www.teknon.es/idcsalud-client/cm/images?idMmedia=444713
Description
Guidelines of AEU (Asociación Española de Urología)

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Efficacy of Transcutaneous Versus Percutaneous Posterior Tibial Nerve Stimulation in the Overactive Bladder.

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