Overactive BladderNCT06935240
Investigation of Effects of Electrical Stimulation in Women With Vaginal Laxity
A study testing Treatment in people with Overactive Bladder, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare the effects of different externally applied electrical stimulation methods on overactive bladder (OAB) symptoms, quality of life, and patients' perception of improvement. 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?
- Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2025to 30 Jun 2026
- 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
- To be between the ages of 18-65 Being diagnosed with AAM Volunteer Becoming literate
Who cannot join
- Sensory loss Presence of infection Having a pacemaker Metal implant presence Malignancy story Having serious cardiovascular problems Presence of severe pelvic organ prolapse (above stage 2) Pregnancy presence Lumbosacral peripheral nerve lesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Effects of External Electrical Stimulation in Women With Vaginal Laxity
The purpose of this study is to compare the effects of different externally applied electrical stimulation methods on overactive bladder (OAB) symptoms, quality of life, and patients' perception of improvement.
Read the detailed description
Current treatment options in the management of AAM are graded into 4 steps by various clinical guidelines. The first step consists of behavioral treatment methods such as lifestyle modification and bladder training and physiotherapy and rehabilitation approaches. Physiotherapy and rehabilitation approaches include various techniques such as pelvic floor muscle training, electrical stimulation (ES), manual therapy and kinesio taping. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive therapeutic method commonly preferred for acute and chronic pain management.
The purpose of TENS in the management of AAM is one of the external ES methods used to inhibit presynaptic afferent neurons carrying impulses from the bladder by stimulating peripheral segmental dermatome nerves. Thus, TENS can affect neural pathways that modulate afferent/efferent impulses in the spinal and supraspinal areas. The portable TENS device is a two-channel output device with self-adhesive electrodes and adjustable treatment frequency and duration. The device is used in AAM by selecting 200 millisecond pulse width and 10 hz frequency parameters. With this frequency, related neural pathways can be modulated and detrusor overactivity can be controlled.
Neuromuscular ES (Innovo ®) (Atlantic Therapeutics, Galway, Ireland), which can be used as external ES in the treatment of AAM, is a new neuromuscular ES device developed to retrain the pelvic floor muscles and inhibit the detrusor muscle through electrodes placed in a garment in the treatment of incontinence. In the literature, this device is also known as a type of external ES application (new generation external ES) applied over the pelvis/hip and can be easily worn and used by the patient. This device is attached to a 2-piece wrapped garment that holds the four electrodes in place in the pelvis/hip with hydrogel adhesive. Program 2 was designed in this device for the presence of urge/pinch type incontinence. This program includes 10 Hz frequency, 250 ms pulse width, 0.5 seconds acceleration and deceleration times, 5 seconds contraction time and 0 seconds parameters. With this program, the nerve controlling the pelvic floor muscle mechanism is stimulated and detrusor overactivity can be controlled.
While tibial nerve stimulation has been mostly used in patients with AAM, it has recently been observed that external ES applications have started to be applied alone or in combination with other treatments. When the literature is reviewed, it is seen that there are a limited number of external ES applications in patients with AAM, but there is no study comparing these applications. Therefore, the aim of this study was to compare the effects of different external ES applications on bladder functions, AAM symptoms, quality of life and patients' perception of recovery in women with AAM. In this sense, it is thought that our study will contribute to the literature and will have original value.
- Conditions
- Overactive Bladder
- Being tested
- Treatment
- 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.
TreatmentDevice
Nöromusculer and Transcutaneus Electrical Neuron stimulations
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in this group will receive only lifestyle recommendations (fluid consumption, diet, weight gain, constipation and bladder irritations) to maintain urinary control. |
| Nöromusculer Es | Experimental | The neuromuscular ES wearable device INNOVO® (Atlantic Therapeutics, Galway, Ireland) will be used three days a week in the supine hook position with urge mode (program 2: 10 Hz frequency, 250 ms pulse width, 0.5 seconds acceleration and deceleration times, 5 seconds contraction time and 0 seconds parameters) along with lifestyle recommendations. The device will be glued around the hip/pelvis of the patients so that the electrodes will coincide with the anterior and posterior of the right and left hip, the right-left pelvic side and the right-left gluteal region. The application will take 30 minutes. Receives: Device: Treatment |
| Tens | Experimental | A current with a pulse width of 200 milliseconds and a frequency of 10 Hz will be applied three days a week in the prone position with a parasacral TENS device (Intelect, economy) along with lifestyle recommendations. Electrodes will be placed bilaterally and parasacrally. The application will last 30 minutes. Receives: Device: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom severity Overactive Bladder-V8 Questionnaire (OAB-V8)
Measured: 6 weeks
Secondary outcomes (1)
bladder diary results
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 posted20 Apr 2025
- Study start10 Mar 2025
- Primary completion30 May 2026
- Study completion30 Jun 2026
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 Selcuk 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
- Model description
- Individuals who meet the inclusion criteria and sign the consent form will be randomly divided into 3 groups (Control, Neuromuscular ES, TENS). Randomization will be performed by a researcher who is not involved in the study using computer-assisted randomization blocks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra KORKUT, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935240
- Sponsor's protocol ID
- 2025/190
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 2 Nov 2026
- 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Effects of External Electrical Stimulation in Women With Vaginal Laxity
- ClinicalTrials.gov ID
- NCT06935240
- Acronym / sponsor ID
- 2025/190
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Collaborators
- Ankara Yildirim Beyazıt University, Necmettin Erbakan University
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 20 Apr 2025 (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 purpose of this study is to compare the effects of different externally applied electrical stimulation methods on overactive bladder (OAB) symptoms, quality of life, and patients' perception of improvement.
Detailed description
Current treatment options in the management of AAM are graded into 4 steps by various clinical guidelines. The first step consists of behavioral treatment methods such as lifestyle modification and bladder training and physiotherapy and rehabilitation approaches. Physiotherapy and rehabilitation approaches include various techniques such as pelvic floor muscle training, electrical stimulation (ES), manual therapy and kinesio taping. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive therapeutic method commonly preferred for acute and chronic pain management.
The purpose of TENS in the management of AAM is one of the external ES methods used to inhibit presynaptic afferent neurons carrying impulses from the bladder by stimulating peripheral segmental dermatome nerves. Thus, TENS can affect neural pathways that modulate afferent/efferent impulses in the spinal and supraspinal areas. The portable TENS device is a two-channel output device with self-adhesive electrodes and adjustable treatment frequency and duration. The device is used in AAM by selecting 200 millisecond pulse width and 10 hz frequency parameters. With this frequency, related neural pathways can be modulated and detrusor overactivity can be controlled.
Neuromuscular ES (Innovo ®) (Atlantic Therapeutics, Galway, Ireland), which can be used as external ES in the treatment of AAM, is a new neuromuscular ES device developed to retrain the pelvic floor muscles and inhibit the detrusor muscle through electrodes placed in a garment in the treatment of incontinence. In the literature, this device is also known as a type of external ES application (new generation external ES) applied over the pelvis/hip and can be easily worn and used by the patient. This device is attached to a 2-piece wrapped garment that holds the four electrodes in place in the pelvis/hip with hydrogel adhesive. Program 2 was designed in this device for the presence of urge/pinch type incontinence. This program includes 10 Hz frequency, 250 ms pulse width, 0.5 seconds acceleration and deceleration times, 5 seconds contraction time and 0 seconds parameters. With this program, the nerve controlling the pelvic floor muscle mechanism is stimulated and detrusor overactivity can be controlled.
While tibial nerve stimulation has been mostly used in patients with AAM, it has recently been observed that external ES applications have started to be applied alone or in combination with other treatments. When the literature is reviewed, it is seen that there are a limited number of external ES applications in patients with AAM, but there is no study comparing these applications. Therefore, the aim of this study was to compare the effects of different external ES applications on bladder functions, AAM symptoms, quality of life and patients' perception of recovery in women with AAM. In this sense, it is thought that our study will contribute to the literature and will have original value.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Individuals who meet the inclusion criteria and sign the consent form will be randomly divided into 3 groups (Control, Neuromuscular ES, TENS). Randomization will be performed by a researcher who is not involved in the study using computer-assisted randomization blocks.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in this group will receive only lifestyle recommendations (fluid consumption, diet, weight gain, constipation and bladder irritations) to maintain urinary control. |
| Nöromusculer Es | Experimental | Device: TreatmentThe neuromuscular ES wearable device INNOVO® (Atlantic Therapeutics, Galway, Ireland) will be used three days a week in the supine hook position with urge mode (program 2: 10 Hz frequency, 250 ms pulse width, 0.5 seconds acceleration and deceleration times, 5 seconds contraction time and 0 seconds parameters) along with lifestyle recommendations. The device will be glued around the hip/pelvis of the patients so that the electrodes will coincide with the anterior and posterior of the right and left hip, the right-left pelvic side and the right-left gluteal region. The application will take 30 minutes. |
| Tens | Experimental | Device: TreatmentA current with a pulse width of 200 milliseconds and a frequency of 10 Hz will be applied three days a week in the prone position with a parasacral TENS device (Intelect, economy) along with lifestyle recommendations. Electrodes will be placed bilaterally and parasacrally. The application will last 30 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be between the ages of 18-65 Being diagnosed with AAM Volunteer Becoming literate
Key exclusion criteria (1 listed)
- Sensory loss Presence of infection Having a pacemaker Metal implant presence Malignancy story Having serious cardiovascular problems Presence of severe pelvic organ prolapse (above stage 2) Pregnancy presence Lumbosacral peripheral nerve lesion
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 |
|---|---|---|
| TreatmentNöromusculer and Transcutaneus Electrical Neuron stimulations | Device | Nöromusculer Es, Tens |
Primary outcome
Symptom severity Overactive Bladder-V8 Questionnaire (OAB-V8)
Time frame: 6 weeks
1 secondary outcome
bladder diary results
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 2 Nov 2026.
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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.
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 Treatment in people with Overactive Bladder, run by Selcuk 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 1 inclusion and 1 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 2 Nov 2026. 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?
Symptom severity Overactive Bladder-V8 Questionnaire (OAB-V8) (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 2 Nov 2026.