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Overactive Bladder SyndromeNCT04483817

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

A study testing Transcutaneous tibial nerve stimulation and Percutaneous tibial nerve stimulation in people with Overactive Bladder Syndrome, run by Fisiocore LC,SL at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Overactive Bladder Syndrome
What is being tested?
Transcutaneous tibial nerve stimulation and Percutaneous tibial nerve stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteSpain
Study dates
17 Jul 2019to 1 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Laura Calzado Sanz, Physiotherap contact

+34 626495479

lauracalzado@lcfisioterapia.com

María Torres Lacomba, Physiotherap contact

+34 678900061

maria.torres@uah.es

Spain1 site, 1 recruiting

  • Laura Calzado Sanz

    Alcalá de Henares, Madrid, 28806

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Transcutaneous tibial nerve stimulation, Percutaneous tibial nerve stimulation
Keywords
urgency, incontinence, nocturia, frequency
Medical subject headings
Nocturia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous tibial nerve stimulationDevice

    Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.

  • Percutaneous tibial nerve stimulationDevice

    Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.

Study groups in NCT04483817
Study groupRoleWhat they receive
A: Transcutaneous tibial nerve stimulationExperimentalThe 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.
Receives: Device: Transcutaneous tibial nerve stimulation
B: Percutaneous tibial nerve stimulationActive comparatorThe 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.
Receives: Device: Percutaneous tibial nerve stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: two years

  2. Nightime voids

    Urinary episodes per night.

    According to international consensus, it is considered pathological when:

    There is more than 1 episode per night.

    Measured: two years

  3. 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.

    Measured: two years

  4. 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;

    1. = Slight urgency;
    2. = Moderate urgency;
    3. = severe urgency;
    4. = urge incontinence.

    Measured: two years

  5. Voided volume

    Urine 24 hours volume. Voiding volume over 3000cc in 24 hours, is considered pathological.

    Measured: two years

Secondary outcomes (3)

  1. 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.

    Measured: Two years

  2. 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.

    Measured: Two years

  3. 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.

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2020
  2. Study start17 Jul 2019
  3. Primary completion1 Feb 2023 (estimated)
  4. Study completion1 Sep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective interventional study
Masking
Single blind
Who is masked
Investigator
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04483817
Sponsor's protocol ID
EC 06/2019
Status last verified
Aug 2022
First submitted
27 Mar 2020
Last updated
9 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26586384

  • 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.

    PubMed 20590544

  • 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.

    PubMed 21092997

  • 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.

    PubMed 20567947

  • 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.

    PubMed 28731583

  • 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.

    PubMed 22581511

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous tibial nerve stimulation and Percutaneous tibial nerve stimulation in people with Overactive Bladder Syndrome, run by Fisiocore LC,SL at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Laura Calzado Sanz, Physiotherap (+34 626495479, lauracalzado@lcfisioterapia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary frequency (time frame: two years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04483817, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.

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