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

Overactive Bladder Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04483817
• Other study ID #: EC 06/2019
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2019
• Est. completion date: September 1, 2023

Study information

• Verified date: August 2022
• Source: Fisiocore LC,SL
• Contact: Laura Calzado Sanz, Physiotherap
• Phone: +34 626495479
• Email: lauracalzado[@]lcfisioterapia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: September 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

Intervention

Device:
• Transcutaneous tibial nerve stimulation
Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.
• Percutaneous tibial nerve stimulation
Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.

Locations

Country	Name	City	State
Spain	Laura Calzado Sanz	Alcalá de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fisiocore LC,SL

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. E — View 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. Review. — View 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. Wooldri — View 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. — View 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. Review. — View 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.1464-4 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	two years
Primary	Nightime voids	Urinary episodes per night.; According to international consensus, it is considered pathological when: There is more than 1 episode per night.	two years
Primary	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.	two years
Primary	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.	two years
Primary	Voided volume	Urine 24 hours volume. Voiding volume over 3000cc in 24 hours, is considered pathological.	two years
Secondary	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.	Two years
Secondary	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.	Two years
Secondary	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.	Two years

External Links

•   Guidelines of AEU (Asociación Española de Urología)
•   Guidelines of urology´s treatments