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

August 8, 2022 updated by: Fisiocore LC,SL

Efficacy of Transcutaneous Versus Percutaneous Posterior Tibial Nerve Stimulation in the Treatment of Overactive Bladder. Randomized Clinical Trial.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: María Torres Lacomba, Physiotherap
  • Phone Number: +34 678900061
  • Email: maria.torres@uah.es

Study Locations

  • Spain
    • Madrid
      • Alcalá de Henares, Madrid, Spain, 28806
        • Recruiting
        • Laura Calzado Sanz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A: Transcutaneous tibial nerve stimulation
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.
Device: Transcutaneous tibial nerve stimulation
Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.
Active Comparator: B: Percutaneous tibial nerve stimulation
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.
Device: Percutaneous tibial nerve stimulation
Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary frequency
Time Frame: two years

Urinary episodes per day.

According to international consensus, it is considered pathological when:

There are more than 8 episodes of urination per day
two years
Nightime voids
Time Frame: two years

Urinary episodes per night.

According to international consensus, it is considered pathological when:

There is more than 1 episode per night.
two years
Urge episodes
Time Frame: two years
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.
two years
Degree of urge to void
Time Frame: two years

Measured through the PPIUS (Patient Perception of Intensity of Urgency Scale).

Scale from 0 to 4, where:

0 = No urgency;

  1. = Slight urgency;
  2. = Moderate urgency;
  3. = severe urgency;
  4. = urge incontinence.
two years
Voided volume
Time Frame: two years
Urine 24 hours volume. Voiding volume over 3000cc in 24 hours, is considered pathological.
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overactive Bladder questionnaire Short- Form (OABq-SF)
Time Frame: Two years

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.
Two years
International Consultation on Incontinence Questionnaire (ICIQ-SF)
Time Frame: Two years
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.
Two years
Benefits, satisfaction and willingness to continue to treatment (BSW)
Time Frame: Two years
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.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisiocore LC,SL

Investigators

  • Principal Investigator: Laura Calzado Sanz, Physiotherap, Fisiocore LC,SL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2019

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

July 21, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC 06/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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