Transcutaneous Tibial Nerve Stimulation in Antimuscarinic Naive and Refractory Women With Idiopathic Overactive Bladder

NCT05668715 | Unknown

• 1 other identifier: pamukkaleu.ftr.NYildiz.001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this study is the first prospective trial that compares the efficacy of TTNS in antimuscarinic naive and refractory women with idiopathic OAB. In this study, it was aimed to compare the effectiveness of TTNS on quality of life (QoL) and clinical parameters related to OAB in antimuscarinic naive and refractory women. The results of this study would make it easier to understand the place of TTNS among the treatment options in women with idiopathic OAB.

Conditions

Urinary Bladder, Overactive

Outcome Measures

Primary Outcomes (1)

• İmprovement in incontinence episodes

  To determine positive response rate, reduction in incontinence episodes was collected from the 3-day bladder diary. Women with ≥a 50% reduction in incontinence episodes were considered positive responders

  6 months

Secondary Outcomes (8)

• Severity of incontinence

  6 months

• The frequencies of voiding

  6 months

• Cure-improvement rate

  6 months

• Change in their urinary incontinence

  6 months

• Nocturia

  6 months

Study Arms (2)

Group 1: Antimuscarinic Naive (AM-N)

EXPERIMENTAL

None of the women had previously taken anti-muscarinic agents and oral ß3 adrenoreceptor agonist (mirabegron) in this group.

Other: Transcutaneous tibial nerve stimulation (TTNS)

Group 2: Antimuscarinic Refractory (AM-R)

ACTIVE COMPARATOR

Women with idiopathic OAB refractory to anti-muscarinic agents and oral ß3 adrenoreceptor agonist (mirabegron) when 2 or more were administered for at least 6 weeks each and failure was due to lack of efficacy with or without side effects were included in this group.

Other: Transcutaneous tibial nerve stimulation (TTNS)

Interventions

Transcutaneous tibial nerve stimulation (TTNS) OTHER

PTNS has some disadvantages such as it is a minimally invasive method applied by needle, and the need to go to the hospital for this. However, the number of studies on transcutaneous tibial nerve stimulation (TTNS) (non-invasive and can be applied at home) tends to increase in recent years

Group 1: Antimuscarinic Naive (AM-N); Group 2: Antimuscarinic Refractory (AM-R)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women 18 years and older with clinically idiopathic OAB
• Having the ability to give written informed consent
• Ability to understand procedures

You may not qualify if:

• Presence of active vaginal or urinary tract infection or malignancy
• Pregnancy or intention to become pregnant during the study
• History of neurogenic bladder, peripheral or central neurological pathology
• Presence of Grade 2 and higher pelvic organ prolapse (POP) according to the International Continence Society (ICS)
• Having undergone urogynecological surgery in the last 3 months
• Women with stress urinary incontinence
• History of PTNS and/or TTNS for OAB in the past 6 months
• Presence of a pacemaker or implanted defibrillator
• Presence of anatomical or post-traumatic malformations / skin disorders of the tibial nerve region of the inner ankle that do not allow the application of electrodes
• PTK strength less than 3/5 (rated as modified Oxford scale, min: 0-max: 5)
• Ultrasonographic evidence of a postvoid residual urine volume greater than 100 ml

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

Related Publications (28)

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MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 30, 2022
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 30, 2023
• Last Updated: December 30, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)