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.
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
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.
Spain1 site, 1 recruiting
- Recruiting
Laura Calzado Sanz
Alcalá de Henares, Madrid, 28806
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.
- Conditions
- Overactive Bladder Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| A: Transcutaneous tibial nerve stimulation | Experimental | 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. Receives: Device: Transcutaneous tibial nerve stimulation |
| B: Percutaneous tibial nerve stimulation | Active comparator | 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. Receives: Device: Percutaneous tibial nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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.
Measured: two years
Voided volume
Urine 24 hours volume. Voiding volume over 3000cc in 24 hours, is considered pathological.
Measured: two years
Secondary outcomes (3)
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
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
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.
- First posted23 Jul 2020
- Study start17 Jul 2019
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fisiocore LC,SL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Calzado Sanz, Physiotherap, Principal investigator, Fisiocore LC,SL
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 26586384Yoong 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 20590544Civic 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 21092997Sajadi 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 20567947Booth 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 28731583Burton 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