Overactive Bladder SyndromeNCT03516435
Efficacy of Different Electrical Stimulation Placement in Patients With Overactive Bladder Syndrome
A study testing Parasacral transcutaneous electrical stimulation and Intravaginal electrical stimulation in people with Overactive Bladder Syndrome, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Parasacral transcutaneous electrical stimulation and Intravaginal electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Apr 2018to 28 Feb 2019
- 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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Urinary incontinence due to detrusor overactivity
- No patients had been taking anticholinergics or tricyclic depressants and none had been treated by pelvic floor exercise, bladder training, or pelvic surgery before entry into the study.
Who cannot join
- stress incontinence
- urinary tract infection
- neurological disease
- genital prolapse higher than stage II on POP-Q system
- pregnancy
- diabetes mellitus
Show all 10Show fewer
- a history of anti-incontinence surgery and/or prolapse repair
- pelvic tumors and previously treated with radiation therapy or antimuscarinic agents
- patients who were not cooperative
- electrical stimulation contraindications
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chung Shan Medical University Hospital
Taichung, 40201
886-4-24739595 ext. 21737, irb@csh.gov.tw
About this study
Official title: Randomized,Single-Blind Controlled Trial
This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder.
Read the detailed description
This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder.The study will adopt a longitudinal research design with randomized quasi-experimental trial.The patients will recruited and be randomly assigned to Group A (Parasacral transcutaneous electrical stimulation) or Group B (Intravaginal electrical stimulation). There will be 30 participants in each group. Data will be collected 2 times.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Parasacral transcutaneous electrical stimulation, Intravaginal electrical stimulation
- Keywords
- Intravaginal electrical stimulation, Parasacral transcutaneous electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasacral transcutaneous electrical stimulationDevice
Asymmetrical biphasic square current pulse Frequency：10 Hz pulse width：1.0 ms Intensity：highest tolerable intensity(≦80 mA.) Parasacral transcutaneous electrical stimulation：Clinic using 2 superficial 3.5 cm electrodes placed on each side of S3 and S4.
Intravaginal electrical stimulationDevice
Asymmetrical biphasic square current pulse Frequency：10 Hz pulse width：1.0 ms Intensity：highest tolerable intensity(≦80 mA.) Intravaginal electrical stimulation：The electrode plug for vaginal plug was cylinder-formed with ring-formed placed into vaginal.
| Study group | Role | What they receive |
|---|---|---|
| Parasacral transcutaneous ES | Experimental | 20min./session, 2 sessions/week ,12 sessions of Parasacral transcutaneous electrical stimulation. Receives: Device: Parasacral transcutaneous electrical stimulation |
| Intravaginal electrical stimulation | Active comparator | 20min./session, 2 sessions/week ,12 sessions of Intravaginal electrical stimulation. Receives: Device: Intravaginal electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 Days Voiding diary
This chart is a record of your voiding and leakage or urine. Choose three (3) separate 24 hour periods to complete this record. Pick days which will be most convenient for you to measure every void.
Measured: 3 days
Secondary outcomes (3)
Overactive Bladder Symptom Score( OABSS）
This is a single symptom score that employs a self-report questionnaire to quantify OAB symptoms.Questionnaire has many items with the same minimum and maximum score.Four question items, daytime frequency, nocturia, urgency and urgency incontinence, were included in the questionnaire according to the definition of OAB.
Measured: 20 min
minVisual analogue scale (VAS) for urgency
The Visual Analog or Analogue Scale (VAS) is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to the amount of urgency they experienced. This gives them the greatest freedom to choose their urgency intensity. It also gives the maximum opportunity for each respondent to express a personal response style. VAS data of this type is recorded as the number of millimeters from the left of the line with the range 0-100.
Measured: 10 min
Pad test
To measure leakage and may be performed in the specialist's office or at home. Pad testing can be done over a period of time as short as twenty minutes or up to one hour.
Measured: 20min-1hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start9 Apr 2018
- Primary completion30 Nov 2018 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeh, Chung Shan Medical University
- Investigators
- Chen Gin-Den, PhD, Study chair, Chung Shan Medical UniversityChen Yi-Ching, MS, Study director, Chung Shan Medical UniversityChang Chia-Yun, MS student, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516435
- Sponsor's protocol ID
- CS17150
- Status last verified
- May 2018
- First submitted
- 24 Apr 2018
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized,Single-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT03516435
- Acronym / sponsor ID
- CS17150
- Conditions
- Overactive Bladder Syndrome
- Keywords
- Intravaginal electrical stimulation, Parasacral transcutaneous electrical stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 4 May 2018 (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.
This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder.
Detailed description
This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder.The study will adopt a longitudinal research design with randomized quasi-experimental trial.The patients will recruited and be randomly assigned to Group A (Parasacral transcutaneous electrical stimulation) or Group B (Intravaginal electrical stimulation). There will be 30 participants in each group. Data will be collected 2 times.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parasacral transcutaneous ES | Experimental | Device: Parasacral transcutaneous electrical stimulation20min./session, 2 sessions/week ,12 sessions of Parasacral transcutaneous electrical stimulation. |
| Intravaginal electrical stimulation | Active comparator | Device: Intravaginal electrical stimulation20min./session, 2 sessions/week ,12 sessions of Intravaginal electrical stimulation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Urinary incontinence due to detrusor overactivity
- No patients had been taking anticholinergics or tricyclic depressants and none had been treated by pelvic floor exercise, bladder training, or pelvic surgery before entry into the study.
Key exclusion criteria (10 listed)
- stress incontinence
- urinary tract infection
- neurological disease
- genital prolapse higher than stage II on POP-Q system
- pregnancy
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 |
|---|---|---|
| Parasacral transcutaneous electrical stimulationAsymmetrical biphasic square current pulse Frequency：10 Hz pulse width：1.0 ms Intensity：highest tolerable intensity(≦80 mA.) Parasacral transcutaneous electrical stimulation：Clinic using 2 superficial 3.5 cm electrodes placed on each side of S3 and S4. | Device | Parasacral transcutaneous ES |
| Intravaginal electrical stimulationAsymmetrical biphasic square current pulse Frequency：10 Hz pulse width：1.0 ms Intensity：highest tolerable intensity(≦80 mA.) Intravaginal electrical stimulation：The electrode plug for vaginal plug was cylinder-formed with ring-formed placed into vaginal. | Device | Intravaginal electrical stimulation |
Primary outcome
3 Days Voiding diary
Time frame: 3 days
This chart is a record of your voiding and leakage or urine. Choose three (3) separate 24 hour periods to complete this record. Pick days which will be most convenient for you to measure every void.
3 secondary outcomes
Overactive Bladder Symptom Score( OABSS）
Time frame: 20 min
minVisual analogue scale (VAS) for urgency
Time frame: 10 min
Pad test
Time frame: 20min-1hr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
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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.
Chen Gin-Den, PhD study chair
Chung Shan Medical University
Chen Yi-Ching, MS study director
Chung Shan Medical University
Chang Chia-Yun, MS student principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parasacral transcutaneous electrical stimulation and Intravaginal electrical stimulation in people with Overactive Bladder Syndrome, run by Chung Shan Medical University at 1 site in Taiwan.
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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 17 May 2018. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Gin-Den, PhD (+886-4-24730022 ext. 11600, gdchentw@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 Days Voiding diary (time frame: 3 days). 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 17 May 2018.