Urge Incontinence Episodes After the Magnetic Stimulation Added to Bladder Training in Women With Idiopathic Overactive BladderNCT04450511
Pelvic Floor Magnetic Stimulation in Women With Idiopathic Overactive Bladder
A study testing Magnetic stimulation -Armchair type (MS) and Bladder Training (BT) in people with Urge Incontinence Episodes After the Magnetic Stimulation Added to Bladder Training in Women With Idiopathic Overactive Bladder, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
In clinical practice, Bladder Training (BT) and Magnetic stimulation (MS) are frequently used together in the treatment of women with idiopathic overactive bladder (OAB). Up to our knowledge, there is no study evaluating the combined effect of magnetic stimulation and bladder training in women with idiopathic OAB in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urge Incontinence Episodes After the Magnetic Stimulation Added to Bladder Training in Women With Idiopathic Overactive Bladder
- What is being tested?
- Magnetic stimulation -Armchair type (MS) and Bladder Training (BT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 29 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 procedures, advantages and possible side effects
- Willing and able to complete the voiding diary and QoL questionnaire
- The strength of PFM 3/5 and more
Who cannot join
- 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
- Cardiac pacemaker, implanted defibrillator, coronary artery stent
- Ongoing treatment for arrhythmia
Show all 12Show fewer
- 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 urogynecological surgery within 3 months
- Ongoing surgical treatment or treatment with implantable devices for urinary incontinence or use of intrauterine copper devices
- Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
- Ultrasonographic evidence of post voiding residual volume more than 100 ml
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effect of Pelvic Floor Magnetic Stimulation and Bladder Training in Women With Idiopathic Overactive Bladder: A Prospective Randomised Controlled Trial
In clinical practice, Bladder Training (BT) and Magnetic stimulation (MS) are frequently used together in the treatment of women with idiopathic overactive bladder (OAB). Up to our knowledge, there is no study evaluating the combined effect of magnetic stimulation and bladder training in women with idiopathic OAB in the literature. Moreover, there is no recommendation on conservative treatment combinations in the guidelines due to insufficient data. At this stage, studies are needed to determine whether it will be effective to use MS in combination with other conservative treatment options. In addition, in the light of our clinical experience, we think that this issue is still open for research. In our study, adding MS to BT in women with idiopathic OAB is thought to contribute additionally to the efficacy of treatment with BT.
Our study is the first prospective randomized controlled trial that compares the efficacy of BT and BT plus MS in women with idiopathic OAB. In this study, we aimed to evaluate the efficacy of MS added to BT on incontinence-related QoL and clinical parameters in women with idiopathic OAB.
Read the detailed description
This study is a prospectively randomized, controlled trial. The trial is held at Urogynecological Rehabilitation Unit of University Hospital, Physical Medicine and Rehabilitation Department between September 2020 and November 2021. The local ethics committee approve the study (approval no: 60116787-020/37878). Patients are informed about the purpose and contents of the study and all women give written consent to participate.
By using a random number generator, all patients which included the study were randomized into two groups as follows: The Group 1 received BT program alone, the Group 2 received BT plus MS.
Group 1: Bladder Training (BT) - 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 pelvic floor muscle (PFM) training programs in two groups.
Group 2: BT plus MS Patients are told to sit on the chair with a magnetic coil below the chair. When a volume conductor is inserted 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 was 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, patients were interviewed so that they received stimuli at the maximum stimulation intensity (maximum tolerable stimulation intensity) (10). MS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks. MS sessions were performed by other physician.
- Being tested
- Magnetic stimulation -Armchair type (MS), Bladder Training (BT)
- Keywords
- idiopathic overactive bladder, bladder training, magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic stimulation -Armchair type (MS)Device
Also called Extracorporeal magnetic stimulation
MS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks.
Bladder Training (BT)Other
Bladder Training (BT)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Bladder Training (BT) | Active comparator | BT, consisting of four stages, did not contain any PFM training programs in all groups. In these stages, including urgency suppression 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 were 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.). Receives: Other: Bladder Training (BT) |
| Group 2: Bladder Training+Magnetic Stimulation | Experimental | Patients are told to sit on the chair with a magnetic coil below the chair. When a volume conductor is inserted 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 was 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 were interviewed so that they received stimuli at the maximum stimulation intensity (maximum tolerable stimulation intensity) . Receives: Device: Magnetic stimulation -Armchair type (MS); Other: Bladder Training (BT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence episodes
Patients with a 50% or greater reduction in incontinence episodes were consider positive responders
Measured: 6 weeks
Secondary outcomes (8)
Severity of incontinence
The 24-hour pad test was carried out to evaluate urinary loss.
Measured: 6 weeks
Nocturia
It was used "nocturia" from data collected with a 3-day bladder diary.
Measured: 6 weeks
Frequency
It was used "frequency" from data collected with a 3-day bladder diary.
Measured: 6 weeks
Number of pads
It was used "number of pads" from data collected with a 3-day bladder diary.
Measured: 6 weeks
Symptom severity
Overactive Bladder Questionnaire (OAB-V8) was used to evaluate symptom severity in patients with in the study.
Measured: 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
Measured: 6 weeks
Sexual Functions
The Female Sexual Function Index (FSFI) is a valid, reliable, and anonymously designed ques¬tionnaire with six areas (desire, subjective arousal, lubrica¬tion, orgasm, satisfaction, pain), and includes 19 questions that measure female sexual function.
Measured: 6 weeks
Cure and improvement rate
In 24-hour pad test, 1.3 gr under of it was considered as a cure. The improvement was assessed in terms of 50% and more reduction in wet weight compared to baseline measurements in the 24-hour pad test
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start1 Sep 2020
- Primary completion30 Sep 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urge Incontinence Episodes After the Magnetic Stimulation Added to Bladder Training in Women With Idiopathic Overactive BladderStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necmettin Yildiz, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450511
- Sponsor's protocol ID
- 60116787-020/37878
- Status last verified
- Oct 2022
- First submitted
- 25 Jun 2020
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Pelvic Floor Magnetic Stimulation and Bladder Training in Women With Idiopathic Overactive Bladder: A Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04450511
- Acronym / sponsor ID
- 60116787-020/37878
- Keywords
- idiopathic overactive bladder, bladder training, magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In clinical practice, Bladder Training (BT) and Magnetic stimulation (MS) are frequently used together in the treatment of women with idiopathic overactive bladder (OAB). Up to our knowledge, there is no study evaluating the combined effect of magnetic stimulation and bladder training in women with idiopathic OAB in the literature. Moreover, there is no recommendation on conservative treatment combinations in the guidelines due to insufficient data. At this stage, studies are needed to determine whether it will be effective to use MS in combination with other conservative treatment options. In addition, in the light of our clinical experience, we think that this issue is still open for research. In our study, adding MS to BT in women with idiopathic OAB is thought to contribute additionally to the efficacy of treatment with BT.
Our study is the first prospective randomized controlled trial that compares the efficacy of BT and BT plus MS in women with idiopathic OAB. In this study, we aimed to evaluate the efficacy of MS added to BT on incontinence-related QoL and clinical parameters in women with idiopathic OAB.
Detailed description
This study is a prospectively randomized, controlled trial. The trial is held at Urogynecological Rehabilitation Unit of University Hospital, Physical Medicine and Rehabilitation Department between September 2020 and November 2021. The local ethics committee approve the study (approval no: 60116787-020/37878). Patients are informed about the purpose and contents of the study and all women give written consent to participate.
By using a random number generator, all patients which included the study were randomized into two groups as follows: The Group 1 received BT program alone, the Group 2 received BT plus MS.
Group 1: Bladder Training (BT) - 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 pelvic floor muscle (PFM) training programs in two groups.
Group 2: BT plus MS Patients are told to sit on the chair with a magnetic coil below the chair. When a volume conductor is inserted 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 was 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, patients were interviewed so that they received stimuli at the maximum stimulation intensity (maximum tolerable stimulation intensity) (10). MS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks. MS sessions were performed by other physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Bladder Training (BT) | Active comparator | Other: Bladder Training (BT)BT, consisting of four stages, did not contain any PFM training programs in all groups. In these stages, including urgency suppression 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 were 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.). |
| Group 2: Bladder Training+Magnetic Stimulation | Experimental | Device: Magnetic stimulation -Armchair type (MS), Other: Bladder Training (BT)Patients are told to sit on the chair with a magnetic coil below the chair. When a volume conductor is inserted 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 was 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 were interviewed so that they received stimuli at the maximum stimulation intensity (maximum tolerable stimulation intensity) . |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 procedures, advantages and possible side effects
Key exclusion criteria (12 listed)
- 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
- Cardiac pacemaker, implanted defibrillator, coronary artery stent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic stimulation -Armchair type (MS)Also: Extracorporeal magnetic stimulationMS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks. | Device | Group 2: Bladder Training+Magnetic Stimulation |
| Bladder Training (BT)Bladder Training (BT) | Other | Group 1: Bladder Training (BT), Group 2: Bladder Training+Magnetic Stimulation |
Primary outcome
Incontinence episodes
Time frame: 6 weeks
Patients with a 50% or greater reduction in incontinence episodes were consider positive responders
8 secondary outcomes
Severity of incontinence
Time frame: 6 weeks
Nocturia
Time frame: 6 weeks
Frequency
Time frame: 6 weeks
Number of pads
Time frame: 6 weeks
Symptom severity
Time frame: 6 weeks
QoL
Time frame: 6 weeks
Sexual Functions
Time frame: 6 weeks
Cure and improvement rate
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic stimulation -Armchair type (MS) and Bladder Training (BT) in people with Urge Incontinence Episodes After the Magnetic Stimulation Added to Bladder Training in Women With Idiopathic Overactive Bladder, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incontinence episodes (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.