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

Last updated: August 8, 2022
Sponsor: Fisiocore LC,SL
Overall Status: Active - Recruiting

Phase

N/A

Condition

Interstitial Cystitis

Treatment

N/A

Clinical Study ID

NCT04483817
EC 06/2019
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 104
Study Start date:
July 17, 2019
Estimated Completion Date:
September 01, 2023

Study 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.

Connect with a study center

  • Laura Calzado Sanz

    Alcalá de Henares, Madrid 28806
    Spain

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.