Overactive BladderNCT04734301
Intravaginal Electrical Stimulation With Different Treatment Frequency in Women With Idiopathic Overactive Bladder
A study testing Intravaginal Electrical Stimulation (2 times/week) and Intravaginal Electrical Stimulation (5 times/week) in people with Overactive Bladder, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Electrical stimulation (ES) is one of the techniques used in urogynecological physiotherapy, which uses implanted or non-implanted electrodes. Intravaginal ES (IVES) is a conservative treatment option, described more than 40 years ago. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Intravaginal Electrical Stimulation (2 times/week) and Intravaginal Electrical Stimulation (5 times/week)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2021to 15 Jul 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 ≥ 18 years old with clinical diagnosis of idiopathic overactive bladder
- 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 quality of life questionnaire
- The strength of pelvic floor muscle score 3/5 and more
Who cannot join
- Women with stress urinary incontinence
- History of conservative therapy for idiopathic overactive bladder within 6 months
- Pregnancy or intention to become pregnant during the study
- Current vulvovaginitis or urinary tract infections or malignancy
- History of urogynecological surgery within 3 months
- Anatomic structural disorders of genital region that could not allow to apply the vaginal probe
Show all 11Show fewer
- More than stage 2 according to the pelvic organ prolapse quantification
- Cardiac pacemaker or implanted defibrillator
- Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
- Ultrasonographic evidence of post-void residual urine volume > 100 ml
- Allergy to condom or lubricant gel that is used with perineometer/vaginal probe
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Intravaginal Electrical Stimulation With Different Treatment Frequency in Women With Idiopathic Overactive Bladder: A Prospective Randomized Controlled Trial
Electrical stimulation (ES) is one of the techniques used in urogynecological physiotherapy, which uses implanted or non-implanted electrodes. Intravaginal ES (IVES) is a conservative treatment option, described more than 40 years ago. IVES is used in patients with OAB and urge urinary incontinence (UUI), for detrusor inhibition. It has been suggested that IVES probably targets the detrusor muscle or pelvic floor muscle (PFM) or afferent innervation in UUI. According to the European Association Urology (EAU) Guidelines; in adults with urinary incontinence, ES may improve urinary incontinence compared to sham treatment. The IVES programs lasted between 4 weeks and 6 months in women with idiopathic OAB, although generally IVES was applied for 4-12 weeks. In most studies, IVES was applied 2-3 times a week, whereas in fewer studies it was applied more frequently. Despite that, no randomised studies compared different treatment frequencies in women with idiopathic OAB and thus, there is no evidence of which frequencies of treatment are the most effective ones. It should be kept in mind that different stimulation frequency may lead to different results. In addition, in the light of scientific evidence and our clinical experience, we think that this issue is still open for research. Better methodological quality studies are needed to obtain a higher level of scientific evidence and to know the optimal treatment frequency for OAB.
Our study is the first prospective randomized controlled trial that compares the efficacy of IVES with different treatment frequency in women with idiopathic OAB. In this study, we aimed to assess the efficacy of 2 times and 5 times in a week IVES added to BT on quality of life (QoL) and clinical parameters asssociated with idiopathic OAB. The results of the our study will be of great benefit in deciding or preferring the treatment frequency and total treatment duration of IVES for the women with idiopathic OAB and their physicians.
Read the detailed description
This study is a prospective, randomized controlled trial. The trial is held at Urogynecological Rehabilitation Unit of Physical Medicine and Rehabilitation Department between February 2021 and July 2021. The local ethics committee approve the study (E-60116787-020-4274). All women are informed about the purpose and contents of the study and all women written consent to participate in the study.
A random allocation sequence was generated at 1:1 ratio. By using a random number generator, women are randomized into two groups as follows: Group 1 receive BT+IVES (2 times/week), Group 2 receive BT+IVES (5 times/week).
All women which are planned to treat during 20 sessions are included in this study.
Bladder Training (BT) All women were informed about BT for 30 minutes in two groups. Then it was given as a written brochure to be implemented as a home program. BT, consisting of four stages, did not contain any PFM training programs. At the first stage, all of the women visited the physician who was blinded to the study groups and at the initial visit, the women were familiarized with the location of the PFM and the pelvic anatomy and pathophysiology. After that information session, squeezing the PFM was shown in practice at least once to use in the urgency suppression strategies via digital palpation technique. In the second stage, 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.). In the third stage, timed voiding program was started. It was carried out in 2 steps: timed voiding and increasing the time between urination considering the voiding diary. At the last stage, the women were encouraged to continue BT. By increasing their motivation that it is an effective treatment method, compliance to the treatment was increased.
Group 1: IVES (2 times in a week) This group included the IVES in addition to all components of the BT. IVES was performed in lithotomy position via electrical stimulation device with a vaginal probe. IVES sessions were performed two times in a week, for 10 weeks. Every session lasted 20 minutes. The intervention comprised a 20-sessions treatment program of ES. The stimulation parameters were frequency at 10 Hz, a 5-10s work-rest cycle and 100 ms pulse width. The symmetric biphasic pulse wave could be delivered over a range of 0-100 milliamp (mA). The intensity was controlled according to patients' discomfort level feedback.
Group 2: IVES (5 times in a week) This group also included the IVES in addition to all components of the BT as in Group 1. IVES performed in the same way as Group 1, except for frequency of treatment. IVES sessions were performed five times in a week, for 4 weeks. Every session lasted 20 minutes. The intervention comprised a 20-sessions treatment program of ES. Stimulation parameters were the same as Group 1.
- Conditions
- Overactive Bladder
- Being tested
- Intravaginal Electrical Stimulation (2 times/week), Intravaginal Electrical Stimulation (5 times/week)
- Keywords
- idiopathic overactive bladder, intravaginal electrical stimulation, bladder training
- 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 (2 times/week)Device
IVES sessions were performed two times in a week, for 10 weeks. Every session lasted 20 minutes. The intervention comprised a 20-sessions treatment program of ES. The stimulation parameters were frequency at 10 Hz, a 5-10s work-rest cycle and 100 ms pulse width. The symmetric biphasic pulse wave could be delivered over a range of 0-100 mA. The intensity was controlled according to patients' discomfort level feedback.
Intravaginal Electrical Stimulation (5 times/week)Device
IVES performed in the same way as Group 1, except for frequency of treatment. IVES sessions were performed five times in a week, for 4 weeks. Every session lasted 20 minutes. The intervention comprised a 20-sessions treatment program of ES. Stimulation parameters were the same as Group 1.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: IVES (2 times in a week) | Active comparator | This group included the IVES in addition to all components of the BT. IVES was performed in lithotomy position via electrical stimulation device with a vaginal probe. Receives: Device: Intravaginal Electrical Stimulation (2 times/week) |
| Group 2: IVES (5 times in a week) | Experimental | This group also included the IVES in addition to all components of the BT as in Group 1. IVES performed in the same way as Group 1, except for frequency of treatment. Receives: Device: Intravaginal Electrical Stimulation (5 times/week) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence episodes-Incontinence related outcome measure
Women with a 50% or greater reduction in incontinence episodes were considered positive responders
Measured: 20 minutes
Secondary outcomes (9)
Severity of incontinence-Incontinence related outcome measure
The 24-hour pad test was carried out to evaluate urinary loss
Measured: 20 sessions (each sessions is 20 minutes )
Nocturia-Incontinence related outcome measure
It was used "nocturia" from data with a 3-day bladder diary
Measured: 20 sessions (each sessions is 20 minutes )
Frequency-Incontinence related outcome measure
It was used "frequency" from data with a 3-day bladder diary
Measured: 20 sessions (each sessions is 20 minutes )
Number of Pads-Incontinence related outcome measure
It was used "number of bads" from data with a 3-day bladder diary
Measured: 20 sessions (each sessions is 20 minutes )
Symptom severity-Incontinence related outcome measure
Overactive Bladder Questionnaire (OAB-V8) was used to evaluate symptom severity in patients with in the study.
Measured: 20 sessions (each sessions is 20 minutes )
PFM strength-Incontinence related outcome measure
To evaluate the PFM strength perineometer device
Measured: 20 sessions (each sessions is 20 minutes )
Quality of Life (QoL)-Incontinence related outcome measure
The incontinence Impact Questionnaire (IIQ-7)scale was used to assess the patient's QoL associated with incontinence problem. The Scale has a minimum score of 0 and a maximum score of 21. Higher scores indicate worse incontinence related QoL.
Measured: 20 sessions (each sessions is 20 minutes )
Cure measured by 24-hour pad test
In 24-hour pad test, incontinence that was under 1.3 gr was considered as a cure.
Measured: 20 sessions (each sessions is 20 minutes )
Improvement rate-Incontinence related outcome measure
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: 20 sessions (each sessions is 20 minutes )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start5 Feb 2021
- Primary completion30 Jun 2021
- Study completion15 Jul 2021
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 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
- 52 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
- NCT04734301
- Sponsor's protocol ID
- E-60116787-020-4274
- Status last verified
- Oct 2022
- First submitted
- 25 Jan 2021
- 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
- Efficacy of Intravaginal Electrical Stimulation With Different Treatment Frequency in Women With Idiopathic Overactive Bladder: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04734301
- Acronym / sponsor ID
- E-60116787-020-4274
- Conditions
- Overactive Bladder
- Keywords
- idiopathic overactive bladder, intravaginal electrical stimulation, bladder training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 2 Feb 2021 (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.
Electrical stimulation (ES) is one of the techniques used in urogynecological physiotherapy, which uses implanted or non-implanted electrodes. Intravaginal ES (IVES) is a conservative treatment option, described more than 40 years ago. IVES is used in patients with OAB and urge urinary incontinence (UUI), for detrusor inhibition. It has been suggested that IVES probably targets the detrusor muscle or pelvic floor muscle (PFM) or afferent innervation in UUI. According to the European Association Urology (EAU) Guidelines; in adults with urinary incontinence, ES may improve urinary incontinence compared to sham treatment. The IVES programs lasted between 4 weeks and 6 months in women with idiopathic OAB, although generally IVES was applied for 4-12 weeks. In most studies, IVES was applied 2-3 times a week, whereas in fewer studies it was applied more frequently. Despite that, no randomised studies compared different treatment frequencies in women with idiopathic OAB and thus, there is no evidence of which frequencies of treatment are the most effective ones. It should be kept in mind that different stimulation frequency may lead to different results. In addition, in the light of scientific evidence and our clinical experience, we think that this issue is still open for research. Better methodological quality studies are needed to obtain a higher level of scientific evidence and to know the optimal treatment frequency for OAB.
Our study is the first prospective randomized controlled trial that compares the efficacy of IVES with different treatment frequency in women with idiopathic OAB. In this study, we aimed to assess the efficacy of 2 times and 5 times in a week IVES added to BT on quality of life (QoL) and clinical parameters asssociated with idiopathic OAB. The results of the our study will be of great benefit in deciding or preferring the treatment frequency and total treatment duration of IVES for the women with idiopathic OAB and their physicians.
Detailed description
This study is a prospective, randomized controlled trial. The trial is held at Urogynecological Rehabilitation Unit of Physical Medicine and Rehabilitation Department between February 2021 and July 2021. The local ethics committee approve the study (E-60116787-020-4274). All women are informed about the purpose and contents of the study and all women written consent to participate in the study.
A random allocation sequence was generated at 1:1 ratio. By using a random number generator, women are randomized into two groups as follows: Group 1 receive BT+IVES (2 times/week), Group 2 receive BT+IVES (5 times/week).
All women which are planned to treat during 20 sessions are included in this study.
Bladder Training (BT) All women were informed about BT for 30 minutes in two groups. Then it was given as a written brochure to be implemented as a home program. BT, consisting of four stages, did not contain any PFM training programs. At the first stage, all of the women visited the physician who was blinded to the study groups and at the initial visit, the women were familiarized with the location of the PFM and the pelvic anatomy and pathophysiology. After that information session, squeezing the PFM was shown in practice at least once to use in the urgency suppression strategies via digital palpation technique. In the second stage, 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.). In the third stage, timed voiding program was started. It was carried out in 2 steps: timed voiding and increasing the time between urination considering the voiding diary. At the last stage, the women were encouraged to continue BT. By increasing their motivation that it is an effective treatment method, compliance to the treatment was increased.
Group 1: IVES (2 times in a week) This group included the IVES in addition to all components of the BT. IVES was performed in lithotomy position via electrical stimulation device with a vaginal probe. IVES sessions were performed two times in a week, for 10 weeks. Every session lasted 20 minutes. The intervention comprised a 20-sessions treatment program of ES. The stimulation parameters were frequency at 10 Hz, a 5-10s work-rest cycle and 100 ms pulse width. The symmetric biphasic pulse wave could be delivered over a range of 0-100 milliamp (mA). The intensity was controlled according to patients' discomfort level feedback.
Group 2: IVES (5 times in a week) This group also included the IVES in addition to all components of the BT as in Group 1. IVES performed in the same way as Group 1, except for frequency of treatment. IVES sessions were performed five times in a week, for 4 weeks. Every session lasted 20 minutes. The intervention comprised a 20-sessions treatment program of ES. Stimulation parameters were the same as Group 1.
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: IVES (2 times in a week) | Active comparator | Device: Intravaginal Electrical Stimulation (2 times/week)This group included the IVES in addition to all components of the BT. IVES was performed in lithotomy position via electrical stimulation device with a vaginal probe. |
| Group 2: IVES (5 times in a week) | Experimental | Device: Intravaginal Electrical Stimulation (5 times/week)This group also included the IVES in addition to all components of the BT as in Group 1. IVES performed in the same way as Group 1, except for frequency of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women ≥ 18 years old with clinical diagnosis of idiopathic overactive bladder
- 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 quality of life questionnaire
Key exclusion criteria (11 listed)
- Women with stress urinary incontinence
- History of conservative therapy for idiopathic overactive bladder within 6 months
- Pregnancy or intention to become pregnant during the study
- Current vulvovaginitis or urinary tract infections or malignancy
- History of urogynecological surgery within 3 months
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 (2 times/week)IVES sessions were performed two times in a week, for 10 weeks. Every session lasted 20 minutes. The intervention comprised a 20-sessions treatment program of ES. The stimulation parameters were frequency at 10 Hz, a 5-10s work-rest cycle and 100 ms pulse width. The symmetric biphasic pulse wave could be delivered over a range of 0-100 mA. The intensity was controlled according to patients' discomfort level feedback. | Device | Group 1: IVES (2 times in a week) |
| Intravaginal Electrical Stimulation (5 times/week)IVES performed in the same way as Group 1, except for frequency of treatment. IVES sessions were performed five times in a week, for 4 weeks. Every session lasted 20 minutes. The intervention comprised a 20-sessions treatment program of ES. Stimulation parameters were the same as Group 1. | Device | Group 2: IVES (5 times in a week) |
Primary outcome
Incontinence episodes-Incontinence related outcome measure
Time frame: 20 minutes
Women with a 50% or greater reduction in incontinence episodes were considered positive responders
9 secondary outcomes
Severity of incontinence-Incontinence related outcome measure
Time frame: 20 sessions (each sessions is 20 minutes )
Nocturia-Incontinence related outcome measure
Time frame: 20 sessions (each sessions is 20 minutes )
Frequency-Incontinence related outcome measure
Time frame: 20 sessions (each sessions is 20 minutes )
Number of Pads-Incontinence related outcome measure
Time frame: 20 sessions (each sessions is 20 minutes )
Symptom severity-Incontinence related outcome measure
Time frame: 20 sessions (each sessions is 20 minutes )
PFM strength-Incontinence related outcome measure
Time frame: 20 sessions (each sessions is 20 minutes )
Quality of Life (QoL)-Incontinence related outcome measure
Time frame: 20 sessions (each sessions is 20 minutes )
Cure measured by 24-hour pad test
Time frame: 20 sessions (each sessions is 20 minutes )
Improvement rate-Incontinence related outcome measure
Time frame: 20 sessions (each sessions is 20 minutes )
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
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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 Intravaginal Electrical Stimulation (2 times/week) and Intravaginal Electrical Stimulation (5 times/week) in people with 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 6 inclusion and 11 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-Incontinence related outcome measure (time frame: 20 minutes). 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.