Overactive BladderNCT05672290
Comparison of the Effects of External Electrical Stimulation Protocols in Women With Overactive Bladder
A study testing Electrical stimulation 1 and Electrical stimulation 2 in people with Overactive Bladder, run by Ankara Yildirim Beyazıt University.
Trial summary
The aim of our study is a comparison of the effects of external electrical stimulation protocols in women with overactive bladder (OAB). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Electrical stimulation 1 and Electrical stimulation 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 Feb 2024
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being in the age range of 18-65 ,
- Having diagnosed with OAB,
- Being a volunteer
Who cannot join
- Being pregnant,
- presence of severe pelvic organ prolapse,
- malignant disease,
- urinary infection,
- neurological disease,
- have electronic and metal implant,
- loss of sensation,
- lumbosacral peripheral nerve lesion
Trial locations and contacts
No sites are listed yet.
About this study
The aim of our study is a comparison of the effects of external electrical stimulation protocols in women with overactive bladder (OAB).
Read the detailed description
OAB is a condition defined by the International Continence Society as the presence of urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. External electrical stimulation has positive effects on OAB. However, there are not enough studies on how often this stimulation is applied. Studies are needed on this subject.
- Conditions
- Overactive Bladder
- Being tested
- Electrical stimulation 1, Electrical stimulation 2
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulation 1Other
External electrical stimulation will be applied for 30 minutes 3 days a week during 6 weeks. Electrodes were placed around the pelvis.
Electrical stimulation 2Other
External electrical stimulation will be applied for 30 minutes one day a week during 6 weeks. Electrodes were placed around the pelvis.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 will be applied external electric stimulation three days per week Receives: Other: Electrical stimulation 1 |
| Group 2 | Active comparator | Group 2 will be applied external electric stimulation one day per week Receives: Other: Electrical stimulation 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overactive bladder symptoms
Overactive bladder symptoms will be assessed with the Overactive Bladder-V8 Questionnaire
Measured: change from baseline at 3 weeks and 6 weeks
Secondary outcomes (5)
Urgency severity
Urgency severity will be assessed with Patients' Perception of Intensity of Urgency Scale
Measured: change from baseline at 3 weeks and 6 weeks
Bladder functions
Bladder functions will be assessed with voiding diary
Measured: change from baseline at 3 weeks and 6 weeks
Life quality
Life quality will be assessed with the King's Health Questionnaire
Measured: change from baseline at 3 weeks and 6 weeks
Strength of pelvic floor muscle
Strength of pelvic floor muscle will be assessed with Modified Oxford Scale
Measured: change from baseline at 3 weeks and 6 weeks
Perception of recovery
Perception of recovery will be assessed with a 4-point Likert scale
Measured: change from baseline at 3 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seyda toprak celenay, Ankara Yildirim Beyazıt University
- Investigators
- Seyda Toprak Celenay, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672290
- Sponsor's protocol ID
- 2023/01/03
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 5 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of External Electrical Stimulation Protocols in Women With Overactive Bladder
- ClinicalTrials.gov ID
- NCT05672290
- Acronym / sponsor ID
- 2023/01/03
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 5 Jan 2023 (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.
The aim of our study is a comparison of the effects of external electrical stimulation protocols in women with overactive bladder (OAB).
Detailed description
OAB is a condition defined by the International Continence Society as the presence of urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. External electrical stimulation has positive effects on OAB. However, there are not enough studies on how often this stimulation is applied. Studies are needed on this subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Electrical stimulation 1Group 1 will be applied external electric stimulation three days per week |
| Group 2 | Active comparator | Other: Electrical stimulation 2Group 2 will be applied external electric stimulation one day per week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being in the age range of 18-65 ,
- Having diagnosed with OAB,
- Being a volunteer
Key exclusion criteria (8 listed)
- Being pregnant,
- presence of severe pelvic organ prolapse,
- malignant disease,
- urinary infection,
- neurological disease,
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 |
|---|---|---|
| Electrical stimulation 1External electrical stimulation will be applied for 30 minutes 3 days a week during 6 weeks. Electrodes were placed around the pelvis. | Other | Group 1 |
| Electrical stimulation 2External electrical stimulation will be applied for 30 minutes one day a week during 6 weeks. Electrodes were placed around the pelvis. | Other | Group 2 |
Primary outcome
Overactive bladder symptoms
Time frame: change from baseline at 3 weeks and 6 weeks
Overactive bladder symptoms will be assessed with the Overactive Bladder-V8 Questionnaire
5 secondary outcomes
Urgency severity
Time frame: change from baseline at 3 weeks and 6 weeks
Bladder functions
Time frame: change from baseline at 3 weeks and 6 weeks
Life quality
Time frame: change from baseline at 3 weeks and 6 weeks
Strength of pelvic floor muscle
Time frame: change from baseline at 3 weeks and 6 weeks
Perception of recovery
Time frame: change from baseline at 3 weeks and 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
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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.
Seyda Toprak Celenay principal investigator
Ankara Yildirim Beyazıt University
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation 1 and Electrical stimulation 2 in people with Overactive Bladder, run by Ankara Yildirim Beyazıt University.
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 3 inclusion and 8 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 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Seyda Toprak Celenay (+90312 906 1000, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overactive bladder symptoms (time frame: change from baseline at 3 weeks and 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 5 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.