Tibial Nerve and Extracorporeal Magnetic Stimulation for Overactive Bladder

NCT05387824 | Unknown

• 1 other identifier: sn 60116787-020/59365
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Overactive bladder (OAB) syndrome is urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection. For the treatment of OAB; pharmacological and non-pharmacological methods are available. The availability and the continuation rate of pharmacological treatments are lower than non-pharmacological treatments due to side effects. Non-pharmacologic treatment methods are evaluated in two groups as active and passive methods. Active methods which active participation of the patient is required during treatment are Pelvic floor muscle exercise (PFME), biofeedback assisted PFME, vaginal cones, while passive methods are Electrical Stimulation, extracorporeal Magnetic Stimulation (MStim) and Transcutaneous Tibial Nerve Stimulation (TTNS) techniques. In this study, investigators aim to evaluate the effectiveness of TTNS and extracorporeal MStim, which are noninvasive methods, added to bladder training (BT) in women with OAB, with a prospective randomized controlled research method.

Conditions

Idiopathic Overactive Bladder; Bladder Training; Transcutaneous Tibial Nerve Stimulation; Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Incontinence episodes

  Patients with a 50% or greater reduction in incontinence episodes were consider positive responders

  6 weeks

Secondary Outcomes (8)

• Severity of incontinence

  6 weeks

• Nocturia

  6 weeks

• Frequency

  6 weeks

• Number of pads

  6 weeks

• Symptom severity

  6 weeks

Study Arms (3)

Group 1: Bladder Training - Control group

ACTIVE COMPARATOR

BT, consisting of four stages, won't contain any PFMT programs in all groups. In these stages, including urgency supression strategies, it was aimed to delay urination, to inhibit detrusor contraction and to prevent urgency; by squeezing the PFM several times in a row (women will be encouraged to pause/ stop their work, sit down if possible, relax the entire body and squeeze PFM repeatedly), breathing deeply, giving their attention to another job for a while and self-motivating (I can do it, I can check the urination, etc.).

Behavioral: Bladder Training

Group 2: Bladder Training + TTNS

EXPERIMENTAL

Two self-adhesive surface electrodes will be positioned according to the protocol which previously explained, with the negative electrode 2 cm behind the medial malleolus and positive electrode 10 cm proximal. Correct positioning wil be determined by noting a hallux reaction (plantar flexion of great toe or fanning of all toes). The stimulation protocol will be delivered at fixed 20 Hz and pulse width 200 ms in continous mode in accordance with the PTNS stimulation protocol. The intensity of the stimulation current (range 0-50 mA) will be determined once correct positioning are established, according to the comfort level of the person. TTNS sessions will be performed twice a week for 6 weeks. Every session will be lasted 30 min. Treatment will consist of 12 sessions of stimulation.

Device: Electrical Stimulation- TTNS; Behavioral: Bladder Training

Group 3: Bladder Training + MStim

EXPERIMENTAL

Patients are told to sit on the chair with a magnetic coil below the chair. When a volume conductor is in serted by this magnetic field, an eddy current flow is generated. This eddy current stimulates nerve or muscle of the pelvic floor. To apply MS, the device will be set to generate its maximum stimuli, with a stimulation pulse width of 200 μs and a stimulation repetition cycle of 10 Hz in accordance with the literature. When setting the device at each treatment session, patients will be interviewed so that they receive the stimuli at the maximum stimulation intensity (maximum tolerable stimulation intensity) .

Device: Magnetic stimulation -Armchair type MS • NovaMag NT-60; Behavioral: Bladder Training

Interventions

Magnetic stimulation -Armchair type MS • NovaMag NT-60 DEVICE

MS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks.

Group 3: Bladder Training + MStim

Electrical Stimulation- TTNS DEVICE

TTNS were performed 2 days a week, for 30 min a day, for a total of 12 sessions for 6 weeks.

Group 2: Bladder Training + TTNS

Bladder Training BEHAVIORAL

Control group All women were informed about BT for 30 minutes. Then it was given as a written brochure to be implemented as a home program. BT, consisting of four stages, did not contain any PFMT programs in two groups.

Group 1: Bladder Training - Control group; Group 2: Bladder Training + TTNS; Group 3: Bladder Training + MStim

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Women over the age of 18 with clinical diagnosis of idiopathic OAB and urodynamically confirmed detrusor overactivity (the presence of detrusor contractions in the filling phase of saline cystometry).
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over the age of 18 with clinical diagnosis of idiopathic OAB Urodynamically confirmed detrusor overactivity (the presence of detrusor contractions in the filling phase of saline cystometry)
• Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks Able to give written, informed consent Able to understand the precedures, 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:

• History of BT, MS therapy
• Pregnancy or intention to become pregnant during the study Current vulvovaginitis or urinary tract infections or malignancy
• More than stage 2 according to the pelvic organ prolapse quantification (POP-Q)
• Cardiac pacemaker, implanted defibrillator, coronary artery stent
• Ongoing treatment for arrhythmia
• Lower abdominal pain or dysmenorrhea
• yet to be diagnosed Electronic device or metallic implant applied to areas between the lumbar region and lower extremities
• Previous urogyneceological surgery within 3 months
• Ongoing surgical treatment or treatment with implantable devices for urinary incontinence or use of intrauterin copper devices
• 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, Kınıklı, 20100, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Yildiz N, Oztekin SNS, Akkoc Y. Comparison of Magnetic and Transcutaenous Tibial Nerve Stimulation Added to Bladder Training for Overactive Bladder: A Randomized Controlled Trial. Int Urogynecol J. 2025 Dec;36(12):2379-2388. doi: 10.1007/s00192-025-06215-w. Epub 2025 Jul 7.

  PMID: 40622410 DERIVED

Study Design

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

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 24, 2022
• Study Start: June 2, 2022
• Primary Completion: October 29, 2022
• Study Completion: November 15, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

TU (1)