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

Pamukkale University

Status: Not yet enrolling

Conditions: Urinary Bladder, Overactive

Treatments: Other: BT (Control group); Other: Transcutaneous MPN stimulation (T-MPNS); Other: Transcutaneous tibial nerve stimulation (TTNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06349694

PamukkaleU.ftr-NYıldız-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

BT plus T-MPNS

Experimental group

Description:

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

Treatment:

Other: Transcutaneous MPN stimulation (T-MPNS)

BT plus TTNS

Experimental group

Description:

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

Treatment:

Other: Transcutaneous tibial nerve stimulation (TTNS)

BT (Control group)

Active Comparator group

Description:

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.

Treatment:

Other: BT (Control group)