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Tibial Nerve and Extracorporeal Magnetic Stimulation for Overactive Bladder

Primary Purpose

Idiopathic Overactive Bladder, Bladder Training, Transcutaneous Tibial Nerve Stimulation

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Magnetic stimulation -Armchair type MS • NovaMag NT-60
Electrical Stimulation- TTNS
Bladder Training
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Overactive Bladder

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Pamukkale UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Group 1: Bladder Training - Control group

Group 2: Bladder Training + TTNS

Group 3: Bladder Training + MStim

Arm Description

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.).

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.

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) .

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Severity of incontinence
The 24-hour pad test was carried out to evaluate urinary loss.
Nocturia
It was used "nocturia" from data collected with a 3-day bladder diary.
Frequency
It was used "frequency" from data collected with a 3-day bladder diary.
Number of pads
It was used "number of pads" from data collected with a 3-day bladder diary.
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.
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.
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.
24-hour pad test (Cure)
In 24-hour pad test, 1.3 gr under of it was considered as a cure.

Full Information

First Posted
May 17, 2022
Last Updated
October 31, 2022
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT05387824
Brief Title
Tibial Nerve and Extracorporeal Magnetic Stimulation for Overactive Bladder
Official Title
Comparison of the Efficacy of Transcutaneous Tibial Nerve Stimulation and Extracorporeal Magnetic Stimulation in Women With Idiopathic Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
October 29, 2022 (Actual)
Study Completion Date
November 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Overactive Bladder, Bladder Training, Transcutaneous Tibial Nerve Stimulation, Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Bladder Training - Control group
Arm Type
Active Comparator
Arm Description
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.).
Arm Title
Group 2: Bladder Training + TTNS
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 3: Bladder Training + MStim
Arm Type
Experimental
Arm Description
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) .
Intervention Type
Device
Intervention Name(s)
Magnetic stimulation -Armchair type MS • NovaMag NT-60
Intervention Description
MS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks.
Intervention Type
Device
Intervention Name(s)
Electrical Stimulation- TTNS
Intervention Description
TTNS were performed 2 days a week, for 30 min a day, for a total of 12 sessions for 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Bladder Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incontinence episodes
Description
Patients with a 50% or greater reduction in incontinence episodes were consider positive responders
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Severity of incontinence
Description
The 24-hour pad test was carried out to evaluate urinary loss.
Time Frame
6 weeks
Title
Nocturia
Description
It was used "nocturia" from data collected with a 3-day bladder diary.
Time Frame
6 weeks
Title
Frequency
Description
It was used "frequency" from data collected with a 3-day bladder diary.
Time Frame
6 weeks
Title
Number of pads
Description
It was used "number of pads" from data collected with a 3-day bladder diary.
Time Frame
6 weeks
Title
Symptom severity
Description
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.
Time Frame
6 weeks
Title
QoL
Description
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.
Time Frame
6 weeks
Title
improvement rate
Description
The improvement was assessed in terms of 50% and more reduction in wet weight compared to baseline measurements in the 24-hour pad test.
Time Frame
6 weeks
Title
24-hour pad test (Cure)
Description
In 24-hour pad test, 1.3 gr under of it was considered as a cure.
Time Frame
6 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
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).
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Pamukkale University
City
Denizli
State/Province
Kınıklı
ZIP/Postal Code
20100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Necmettin Yıldız, Professor MD
Phone
+905334147399
Email
necmi74tr@hotmail.com
First Name & Middle Initial & Last Name & Degree
Saadet Nur Sena Öztekin, MD
Phone
+905434721066
Email
senaoztekin@gmail.com
First Name & Middle Initial & Last Name & Degree
Yeşim Akkoç, Professor MD
First Name & Middle Initial & Last Name & Degree
Özgür Yeniel, Associated Professor MD
First Name & Middle Initial & Last Name & Degree
Ece Çınar, Assistant Professor MD

12. IPD Sharing Statement

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Tibial Nerve and Extracorporeal Magnetic Stimulation for Overactive Bladder

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