Comparison of the Efficacy of Transcutaneos Nerve Stimulations in Women With Idiopathic Overactive Bladder

NCT06349694 | Not Yet Recruiting

• 1 other identifier: PamukkaleU.ftr-NYıldız-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Our study is the first prospective randomized controlled trial that compares the effectiveness of transcutaneous medial plantar nerve stimulation (T-MPNS) and transcutaneous tibial nerve stimulation (TTNS) added to bladder training (BT) in women with idiopathic overactive bladder (OAB). İn this study, we aimed to assess the efficacy of T-MPNS and TTNS added to BT on quality of life (QoL) and clinical parameters asssociated with idiopathic OAB. In addition, preparation time for stimulation, treatment satisfaction and discomfort levels of the patients were evaluated. The main questions we aim to answer are: Is T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied.

Conditions

Urinary Bladder, Overactive

Keywords

Idiopatic overactive bladder; Transcutaneous medial plantar nerve stimulation; Transcutaneous tibial nerve stimulation

Outcome Measures

Primary Outcomes (1)

• Improvement in incontinence episodes (positive response rate)

  Reduction in incontinence episodes will be collected from the 3-day bladder diary. Woman with ≥50% reduction in incontinence episodes were considered positive responders

  Change from baseline positive response rate at the 6th week after the treatment

Secondary Outcomes (8)

• The severity of incontinence

  Change from baseline the 24-hour pad test at the 6th week after the treatment

• Symptom severity

  Change from baseline Overactive Bladder Questionnaire (OAB-V8) at the 6th week after the treatment

• Frequency of voiding, nocturia, number of pads

  Change from baseline voiding, nocturia, and the number of pads used will be collected from the 3-day bladder diary at the 6th week after the treatment

• Quality of life (IIQ7)

  Change from baseline point of The Quality of Life-Incontinence Impact Questionnaire at the 6th week after the treatment

• The Hospital Anxiety and Depression Scale (HAD)

  Change from baseline point of The Hospital Anxiety and Depression Scale (HAD) at the 6th week after the treatment

Study Arms (3)

BT plus T-MPNS

EXPERIMENTAL

T-MPNS sessions will be performed twice a week for 6 weeks. Each session will be lasted 30 minutes. The intervention will be included a 12-session BT plus T-MPNS treatment program

Other: Transcutaneous MPN stimulation (T-MPNS)

BT plus TTNS

EXPERIMENTAL

TTNS sessions will be performed twice a week for 6 weeks. Each session will be lasted 30 minutes. The intervention will be included a 12-session BT plus TTNS treatment program

Other: Transcutaneous tibial nerve stimulation (TTNS)

BT (Control group)

ACTIVE COMPARATOR

Information about BT will be explained to patients for 30 min. Then written form about BT will be given to be implemented as a home program.

Other: BT (Control group)

Interventions

Transcutaneous MPN stimulation (T-MPNS) OTHER

Transcutaneous MPN stimulation (T-MPNS) is the electrostimulation of the lumbosacral roots that produce an activation of the lumbosacral plexus that controls the visceral organs and the pelvic floor muscles, thereby improving bladder control.

BT plus T-MPNS

Transcutaneous tibial nerve stimulation (TTNS) OTHER

Transcutaneous tibial nerve stimulation (TTNS) is the electrostimulation of the lumbosacral roots that produce an activation of the lumbosacral plexus that controls the visceral organs and the pelvic floor muscles, thereby improving bladder control.

BT plus TTNS

BT (Control group) OTHER

Conventional bladder training

BT (Control group)

Eligibility Criteria

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

You may qualify if:

• Women over the age of 18 with clinical diagnosis of idiopathic OAB
• Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks
• Able to understand the procedures, advantages and possible side effects
• Willing and able to complate the voiding diary and QoL questionnaire
• The strength of PFM 3/5 and more

You may not qualify if:

• Women with stress urinary incontinence
• History of conservative therapy (BT, T-MPNS and TTNS/PTNS) within 6 months
• Pregnancy or intention to become pregnant during the study
• Current vulvovaginitis or urinary tract infections or malignancy
• Anatomic or posttraumatic malformations/skin disorders of medial plantar/tibial nerve region on inner foot/ankle that cannot allow to apply the electrodes
• More than stage 2 according to the pelvic organ prolapse quantification (POP-Q)
• Cardiac pacemaker, implanted defibrillator
• Previous urogyneceological surgery within 3 months
• Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
• Ultrasonographic evidence of PVR volume more than 100 ml

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

Related Publications (19)

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MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Control Groups

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Necmettin Yıldız, Prof.

  Pamukkale University

  STUDY DIRECTOR

Central Study Contacts

Rabia Melis Gündoğan, M.d

CONTACT

+905544730153; r.gundogan@gmail.com

Study Design

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

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: April 22, 2024
• Primary Completion: January 31, 2025
• Study Completion: February 28, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)