Comparison of the Efficacy of Transcutaneous Tibial Nerve Stimulation and Extracorporeal Magnetic Stimulation in Women With Idiopathic Overactive Bladder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Pamukkale University
- Enrollment
- 66
- Locations
- 2
- Primary Endpoint
- Incontinence episodes
Study Overview
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.
Detailed Description
This study is a prospectively randomized, controlled trial. The trial will be held at Urogynecological Rehabilitation Unit of Pamukkale University, Physical Medicine and Rehabilitation Department between Nisan 2022 and October 2022. The local ethics committee approved the study (approvel no: 60116787-020/59365).
Participants will be informed about the purpose and contents of the study and all women give written consent to participate. By using a random number generator, all participants who include the study will be randomized into three groups as follows: The Group 1 will receive BT program alone, the Group 2 will be applied to BT plus TTNS, The Group 3 was applied to BT plus MStim.
Group 1: BT - Control group:
All women will be informed about BT for 30 minutes. Then it will be given as a written brochure to be implemented as a home program.
BT, consisting of four stages, will not contain any PFMT programs in anyone of three groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Incontinence episodes
Time Frame: 6 weeks
Patients with a 50% or greater reduction in incontinence episodes were consider positive responders
Secondary Outcomes
- Frequency(6 weeks)
- Severity of incontinence(6 weeks)
- Symptom severity(6 weeks)
- QoL(6 weeks)
- 24-hour pad test (Cure)(6 weeks)
- Nocturia(6 weeks)
- Number of pads(6 weeks)
- improvement rate(6 weeks)
Investigators
Necmettin Yildiz
Professor Medical Doctor
Pamukkale University