Clinical trial NCT04483817: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Overactive Bladder Syndrome
Keywords: urgency
incontinence
nocturia
frequency
Lead sponsor: Fisiocore LC,SL
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective interventional study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Urinary frequency
timeFrame: two years
measure: Nightime voids
timeFrame: two years
measure: Urge episodes
timeFrame: two years
measure: Degree of urge to void
timeFrame: two years
measure: Voided volume
timeFrame: two years
Secondary outcomes:
measure: Overactive Bladder questionnaire Short- Form (OABq-SF)
timeFrame: Two years
measure: International Consultation on Incontinence Questionnaire (ICIQ-SF)
timeFrame: Two years
measure: Benefits, satisfaction and willingness to continue to treatment (BSW)
timeFrame: Two years
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: Laura Calzado Sanz
state: Madrid
Study officials:
affiliation: Fisiocore LC,SL
name: Laura Calzado Sanz, Physiotherap
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.