NCT04483817

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

3.5 years

First QC Date

March 27, 2020

Last Update Submit

August 8, 2022

Conditions

Overactive Bladder Syndrome

Keywords

urgencyincontinencenocturiafrequency

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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.

    two years

  • Voided volume

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

    two years

Secondary Outcomes (3)

  • Overactive Bladder questionnaire Short- Form (OABq-SF)

    Two years

  • International Consultation on Incontinence Questionnaire (ICIQ-SF)

    Two years

  • Benefits, satisfaction and willingness to continue to treatment (BSW)

    Two years

Study Arms (2)

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.

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.

Device: Percutaneous tibial nerve stimulation

Interventions

Transcutaneous tibial nerve stimulationDEVICE

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

A: Transcutaneous tibial nerve stimulation
Percutaneous tibial nerve stimulationDEVICE

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

B: Percutaneous tibial nerve stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laura Calzado Sanz

Alcalá de Henares, Madrid, 28806, Spain

RECRUITING

Related Publications (6)

  • 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.

    PMID: 26586384BACKGROUND

  • 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.

    PMID: 20590544RESULT

  • 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.

    PMID: 21092997RESULT

  • 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.

    PMID: 20567947RESULT

  • 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.

    PMID: 28731583RESULT

  • 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.

    PMID: 22581511RESULT

Related Links

MeSH Terms

Conditions

Nocturia

Condition Hierarchy (Ancestors)

Lower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Laura Calzado Sanz, Physiotherap

    Fisiocore LC,SL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Calzado Sanz, Physiotherap

CONTACT

+34 626495479lauracalzado@lcfisioterapia.com

María Torres Lacomba, Physiotherap

CONTACT

+34 678900061maria.torres@uah.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective interventional study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2020

First Posted

July 23, 2020

Study Start

July 17, 2019

Primary Completion

February 1, 2023

Study Completion

September 1, 2023

Last Updated

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)