Urinary Bladder, OveractiveNCT05416450
The Efficacy of Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder
A study testing intravaginal electrical stimulation added to bladder training in people with Urinary Bladder, Overactive, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to compare the effectiveness of intravaginal electrical stimulation (IVES) added to bladder training (BT) on quality of life (QoL) and clinical parameters related to overactive bladder (OAB) in antimuscarinic naive and refractory women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- intravaginal electrical stimulation added to bladder training
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 5 Jan 2023
- 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
- Over the age of 18 with the clinical diagnosis of idiopathic OAB
- Who could able to give written informed consent and understand the procedures
Who cannot join
- Women who had stress urinary incontinence
- A history of conservative therapy (BT, ES) for OAB within 6 months
- Urogynecological surgery within 3 months
- Current vulvovaginitis or urinary tract infections or malignancy
- Pregnancy
- Cardiac pacemaker or implanted defibrillator
Show all 13Show fewer
- Anatomic structural disorders of the genital region that did not allow to apply the vaginal probe
- The strength of PFM less than 3/5 (graded as modified Oxford scale, min:0-max:5)
- The pelvic organ prolapse quantification (POP-Q) (stage 2 or more)
- Neurogenic bladder
- The peripheral or central neurologic pathology
- Ultrasonographic evidence of post-void residual urine volume more than 100 ml
- Allergy to condom or lubricant gel that is used with vaginal probe
Trial locations and contacts
1 site in 1 country.
Necmettin Yıldız, Prof contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pamukkale Univercity
Denizli
Necmettin Yıldız
About this study
Official title: Comparison of the Efficacy of Intravaginal Electrical Stimulation in Antimuscarinic Naive and Refractory Women With Idiopathic Overactive Bladder
In this study, it was aimed to compare the effectiveness of intravaginal electrical stimulation (IVES) added to bladder training (BT) on quality of life (QoL) and clinical parameters related to overactive bladder (OAB) in antimuscarinic naive and refractory women. The results of this study would make it easier to understand the place of IVES among the treatment options in women with idiopathic OAB.
Read the detailed description
Overactive bladder (OAB) is a symptom complex defined as urgency, with or without urgency urinary incontinence (UUI), usually with frequency and nocturia in the absence of urinary tract infection. Some authors listed the treatment options in idiopathic OAB as follows; first-line - behavioral therapy (lifestyle modifications, pelvic floor muscle (PFM) training, bladder training (BT), timed voiding), second-line - pharmacologic (antimuscarinic, beta-3 agonists), and third-line - neuromodulation/chemodenervation (tibial nerve stimulation, sacral neuromodulation, intradetrusor botulinum toxin). Intravaginal electrical stimulation (IVES) is involved in pelvic floor muscle training as a first-line treatment option. On the contrary, some authors stated that "the first-line treatment of idiopathic OAB includes behavior modification and physical therapy, and neuromodulation methods are used as third-line therapy in cases refractory to first-line and second-line (pharmacological) treatment. IVES, tibial nerve stimulation, and sacral neuromodulation are included as neuromodulation options". However, it is known that many patients with idiopathic OAB receive pharmacological treatment before reaching a conservative treatment option such as IVES. In common practice, antimuscarinic agents are frequently used as an initial treatment although burdened by a low adherence, and these patients need protracted treatment with periodic controls.
Some studies included subjects were not used antimuscarinics within the last 4-12 weeks or antimuscarinic-naive patients with OAB, while some included patients with OAB who were unresponsive or intolerant to antimuscarinics. As a result, IVES appear to be effective therapies used both as first-line treatment, as well as in managing refractory patients with idiopathic OAB. There is no evidence that it is most effective in which patients (antimuscarinic naive and refractory). Would it be more effective on the first-line or the third-line? or in other words; is there a difference in response to IVES in antimuscarinic naive and refractory patients with OAB? It should be kept in mind that IVES may lead to different results in antimuscarinic naive and refractory patients with idiopathic OAB. This study is the first prospective trial that compares the efficacy of IVES in antimuscarinic naive and refractory women with idiopathic OAB. In this study, it was aimed to compare the effectiveness of IVES added to BT on quality of life (QoL) and clinical parameters related to OAB in antimuscarinic naive and refractory women. The results of this study would make it easier to understand the place of IVES among the treatment options in women with idiopathic OAB.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- intravaginal electrical stimulation added to bladder training
- Keywords
- bladder training, intravaginal electrical stimulation
- 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.
intravaginal electrical stimulation added to bladder trainingDevice
BT was given as a home program. After information session, squeezing the PFM was shown in practice at least once to use in the urgency suppression strategies via digital palpation technique. The second stage strategies was aimed to delay urination, inhibit detrusor contraction, and prevent urgency by squeezing the PFM several times on a row, breathing deeply and self-motivating. In the third stage, a timed voiding program was started; a timed voiding and increasing the time between urination considering the voiding diary. IVES was applied in addition to BT in both groups. It was performed in lithotomy position via a stimulation device (Enraf Nonius Myomed 632) with a vaginal probe; three days a week, a total of 24 sessions for 8 weeks. Every session lasted 20 minutes. The stimulation parameters were a 10 Hz of frequency, a 5-10 s of work-rest cycle duration and, a 100 ms of pulse width. The symmetric biphasic pulse wave could be delivered over a range of 1-100 mA.
| Study group | Role | What they receive |
|---|---|---|
| Antimuscarinic Naive (AM-N) | Active comparator | None of the women had previously taken anti-muscarinic agents and oral ß3 adrenoreceptor agonist (mirabegron) in this group. Receives: Device: intravaginal electrical stimulation added to bladder training |
| Antimuscarinic Refractory (AM-R) | Active comparator | Women with idiopathic OAB refractory to anti-muscarinic agents and oral ß3 adrenoreceptor agonist (mirabegron) when 2 or more were administered for at least 6 weeks each and failure was due to lack of efficacy with or without side effects were included in this group. Receives: Device: intravaginal electrical stimulation added to bladder training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence episodes (positive response rate)
To determine positive response rate, reduction in incontinence episodes was collected from the 3-day bladder diary. Women with ≥a 50% reduction in incontinence episodes were considered positive responders.
Measured: Change from baseline at the 8th week after the treatment
Secondary outcomes (6)
the severity of incontinence
The 24-hour pad test was carried out to evaluate the severity of incontinence .
Measured: Change from baseline at the 8th week after the treatment
symptom severity
Overactive Bladder Questionnaire (OAB-V8) was used to evaluate the symptom severity in patients with OAB in this study. The OAB-V8 consists of 8 questions in which the patients can be classified with respect to the symptom severity: none (0), very little (1), a little (2), quite a few (3), very (4), and too many (5). The total score ranges from 0-40.
Measured: Change from baseline at the 8th week after the treatment
frequency of voiding
The frequencies of voiding, nocturia, and the number of pads used were collected from the 3-day bladder diary.
Measured: Change from baseline at the 8th week after the treatment
nocturia
The frequencies of voiding, nocturia, and the number of pads used were collected from the 3-day bladder diary.
Measured: Change from baseline at the 8th week after the treatment
number of pads
The frequencies of voiding, nocturia, and the number of pads used were collected from the 3-day bladder diary.
Measured: Change from baseline at the 8th week after the treatment
quality of life (QoL)
The Quality of Life-Incontinence Impact Questionnaire (IIQ7) was used to assess specific QoL related to incontinence. Minimum score is 0, maximum score is 21 and high scores mention worse outcome.
Measured: Change from baseline at the 8th week after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Jul 2022
- Primary completion15 Dec 2022 (estimated)
- Study completion5 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder, OveractiveStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necmettin Yildiz, Pamukkale University
- Investigators
- Necmettin Yıldız, Prof, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416450
- Sponsor's protocol ID
- PamukkaleU-Unal-001
- Status last verified
- Oct 2022
- First submitted
- 8 Jun 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yildiz N, Unal B. Comparison of the efficacy of intravaginal electrical stimulation in women with idiopathic overactive bladder naive and refractory to pharmacological agents. Int Urogynecol J. 2023 Sep;34(9):2099-2105. doi: 10.1007/s00192-023-05517-1. Epub 2023 Mar 28.
PubMed 36976326
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
- Comparison of the Efficacy of Intravaginal Electrical Stimulation in Antimuscarinic Naive and Refractory Women With Idiopathic Overactive Bladder
- ClinicalTrials.gov ID
- NCT05416450
- Acronym / sponsor ID
- PamukkaleU-Unal-001
- Conditions
- Urinary Bladder, Overactive
- Keywords
- bladder training, intravaginal electrical stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 5 Jan 2023 (estimated)
- First posted
- 13 Jun 2022 (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 this study, it was aimed to compare the effectiveness of intravaginal electrical stimulation (IVES) added to bladder training (BT) on quality of life (QoL) and clinical parameters related to overactive bladder (OAB) in antimuscarinic naive and refractory women. The results of this study would make it easier to understand the place of IVES among the treatment options in women with idiopathic OAB.
Detailed description
Overactive bladder (OAB) is a symptom complex defined as urgency, with or without urgency urinary incontinence (UUI), usually with frequency and nocturia in the absence of urinary tract infection. Some authors listed the treatment options in idiopathic OAB as follows; first-line - behavioral therapy (lifestyle modifications, pelvic floor muscle (PFM) training, bladder training (BT), timed voiding), second-line - pharmacologic (antimuscarinic, beta-3 agonists), and third-line - neuromodulation/chemodenervation (tibial nerve stimulation, sacral neuromodulation, intradetrusor botulinum toxin). Intravaginal electrical stimulation (IVES) is involved in pelvic floor muscle training as a first-line treatment option. On the contrary, some authors stated that "the first-line treatment of idiopathic OAB includes behavior modification and physical therapy, and neuromodulation methods are used as third-line therapy in cases refractory to first-line and second-line (pharmacological) treatment. IVES, tibial nerve stimulation, and sacral neuromodulation are included as neuromodulation options". However, it is known that many patients with idiopathic OAB receive pharmacological treatment before reaching a conservative treatment option such as IVES. In common practice, antimuscarinic agents are frequently used as an initial treatment although burdened by a low adherence, and these patients need protracted treatment with periodic controls.
Some studies included subjects were not used antimuscarinics within the last 4-12 weeks or antimuscarinic-naive patients with OAB, while some included patients with OAB who were unresponsive or intolerant to antimuscarinics. As a result, IVES appear to be effective therapies used both as first-line treatment, as well as in managing refractory patients with idiopathic OAB. There is no evidence that it is most effective in which patients (antimuscarinic naive and refractory). Would it be more effective on the first-line or the third-line? or in other words; is there a difference in response to IVES in antimuscarinic naive and refractory patients with OAB? It should be kept in mind that IVES may lead to different results in antimuscarinic naive and refractory patients with idiopathic OAB. This study is the first prospective trial that compares the efficacy of IVES in antimuscarinic naive and refractory women with idiopathic OAB. In this study, it was aimed to compare the effectiveness of IVES added to BT on quality of life (QoL) and clinical parameters related to OAB in antimuscarinic naive and refractory women. The results of this study would make it easier to understand the place of IVES among the treatment options in women with idiopathic OAB.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antimuscarinic Naive (AM-N) | Active comparator | Device: intravaginal electrical stimulation added to bladder trainingNone of the women had previously taken anti-muscarinic agents and oral ß3 adrenoreceptor agonist (mirabegron) in this group. |
| Antimuscarinic Refractory (AM-R) | Active comparator | Device: intravaginal electrical stimulation added to bladder trainingWomen with idiopathic OAB refractory to anti-muscarinic agents and oral ß3 adrenoreceptor agonist (mirabegron) when 2 or more were administered for at least 6 weeks each and failure was due to lack of efficacy with or without side effects were included in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over the age of 18 with the clinical diagnosis of idiopathic OAB
- Who could able to give written informed consent and understand the procedures
Key exclusion criteria (13 listed)
- Women who had stress urinary incontinence
- A history of conservative therapy (BT, ES) for OAB within 6 months
- Urogynecological surgery within 3 months
- Current vulvovaginitis or urinary tract infections or malignancy
- 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 |
|---|---|---|
| intravaginal electrical stimulation added to bladder trainingBT was given as a home program. After information session, squeezing the PFM was shown in practice at least once to use in the urgency suppression strategies via digital palpation technique. The second stage strategies was aimed to delay urination, inhibit detrusor contraction, and prevent urgency by squeezing the PFM several times on a row, breathing deeply and self-motivating. In the third stage, a timed voiding program was started; a timed voiding and increasing the time between urination considering the voiding diary. IVES was applied in addition to BT in both groups. It was performed in lithotomy position via a stimulation device (Enraf Nonius Myomed 632) with a vaginal probe; three days a week, a total of 24 sessions for 8 weeks. Every session lasted 20 minutes. The stimulation parameters were a 10 Hz of frequency, a 5-10 s of work-rest cycle duration and, a 100 ms of pulse width. The symmetric biphasic pulse wave could be delivered over a range of 1-100 mA. | Device | Antimuscarinic Naive (AM-N), Antimuscarinic Refractory (AM-R) |
Primary outcome
Incontinence episodes (positive response rate)
Time frame: Change from baseline at the 8th week after the treatment
To determine positive response rate, reduction in incontinence episodes was collected from the 3-day bladder diary. Women with ≥a 50% reduction in incontinence episodes were considered positive responders.
6 secondary outcomes
the severity of incontinence
Time frame: Change from baseline at the 8th week after the treatment
symptom severity
Time frame: Change from baseline at the 8th week after the treatment
frequency of voiding
Time frame: Change from baseline at the 8th week after the treatment
nocturia
Time frame: Change from baseline at the 8th week after the treatment
number of pads
Time frame: Change from baseline at the 8th week after the treatment
quality of life (QoL)
Time frame: Change from baseline at the 8th week after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 36976326Yildiz N, Unal B. Comparison of the efficacy of intravaginal electrical stimulation in women with idiopathic overactive bladder naive and refractory to pharmacological agents. Int Urogynecol J. 2023 Sep;34(9):2099-2105. doi: 10.1007/s00192-023-05517-1. Epub 2023 Mar 28.
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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.
Necmettin Yıldız, Prof contact
Necmettin Yıldız, Prof study director
Pamukkale 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 intravaginal electrical stimulation added to bladder training in people with Urinary Bladder, Overactive, 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 2 inclusion and 13 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Burak Unal, M. D. (+905466033240, burakunal_3293@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incontinence episodes (positive response rate) (time frame: Change from baseline at the 8th week after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05416450, which also lists 1 linked publication.
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.