Tibial Nerve and Extracorporeal Magnetic Stimulation for Overactive Bladder

Comparison of the Efficacy of Transcutaneous Tibial Nerve Stimulation and Extracorporeal Magnetic Stimulation in Women With Idiopathic Overactive Bladder

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.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Overactive Bladder; Bladder Training; Transcutaneous Tibial Nerve Stimulation; Magnetic Stimulation
• Intervention / Treatment: Behavioral: Bladder Training; Device: Electrical Stimulation- TTNS; Device: Magnetic stimulation -Armchair type MS • NovaMag NT-60

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.

Group 2: BT plus TTNS:

Two self-adhesive surface electrodes will be positioned according to the protocol previously used with the negative electrode 2 cm behind the medial malleolus and positive electrode 10 cm proximal. Correct positioning will 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 was 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.

Group 3: BT plus MStim:

Pariticipants will be 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 MStim, 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 (10,13-15). When setting the device at each treatment session, participants will be interviewed so that they'll receive stimuli at the maximum stimulation intensity (maximum tolerable stimulation intensity). MStim will be applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks. MStim sessions will be performed by other physician.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kınıklı
    • Denizli, Kınıklı, Turkey, 20100
      • Recruiting
      • Pamukkale University
      • Contact: Necmettin Yıldız, Professor MD; Phone Number: +905334147399; Email: necmi74tr@hotmail.com
      • Contact: Saadet Nur Sena Öztekin, MD; Phone Number: +905434721066; Email: senaoztekin@gmail.com
      • Principal Investigator: Yeşim Akkoç, Professor MD
      • Sub-Investigator: Özgür Yeniel, Associated Professor MD
      • Sub-Investigator: Ece Çınar, Assistant Professor MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1: Bladder Training - Control group; 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; 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.
EXPERIMENTAL: Group 2: Bladder Training + TTNS; 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.	Behavioral: Bladder Training; 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.; Device: Electrical Stimulation- TTNS; TTNS were performed 2 days a week, for 30 min a day, for a total of 12 sessions for 6 weeks.
EXPERIMENTAL: Group 3: Bladder Training + MStim; 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) .	Behavioral: Bladder Training; 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.; Device: Magnetic stimulation -Armchair type MS • NovaMag NT-60; MS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incontinence episodes	Patients with a 50% or greater reduction in incontinence episodes were consider positive responders	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of incontinence	The 24-hour pad test was carried out to evaluate urinary loss.	6 weeks
Nocturia	It was used "nocturia" from data collected with a 3-day bladder diary.	6 weeks
Frequency	It was used "frequency" from data collected with a 3-day bladder diary.	6 weeks
Number of pads	It was used "number of pads" from data collected with a 3-day bladder diary.	6 weeks
Symptom severity	Overactive Bladder Questionnaire (OAB-V8) was used to evaluate symptom severity in patients with in the study. Minimum score is 0, maximum score is 40 and high scores mention worse outcome.	6 weeks
QoL	The Incontinence Impact Questionnaire (IIQ-7) scale which has great validity in studies was used to assess the patient's QoL associated with incontinence problem. Minimum score is 0, maximum score is 21 and high scores mention worse outcome.	6 weeks
improvement rate	The improvement was assessed in terms of 50% and more reduction in wet weight compared to baseline measurements in the 24-hour pad test.	6 weeks
24-hour pad test (Cure)	In 24-hour pad test, 1.3 gr under of it was considered as a cure.	6 weeks

Collaborators and Investigators

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 2, 2022
• Primary Completion (ACTUAL): October 29, 2022
• Study Completion (ANTICIPATED): November 15, 2022

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (ACTUAL): May 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: sn 60116787-020/59365

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No