Idiopathic Overactive BladderNCT04389307
Intravaginal Electrical Stimulation in Idiopathic Overactive Bladder
A study testing Electrical stimulation (IVES) and Bladder Training in people with Idiopathic Overactive Bladder and Electrical Stimulation, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Overactive bladder (OAB) is a symptom complex defined as urgency, with or without urge urinary incontinence (UUI), usually with frequency and nocturia, in the absence of urinary tract infection. Currently, a wide range of therapeutic options exist for the treatment of OAB. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Idiopathic Overactive Bladder, Electrical Stimulation, Bladder Training
- What is being tested?
- Electrical stimulation (IVES) and Bladder Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 31 Dec 2020
- 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 over the age of 18 with clinical diagnosis of idiopathic OAB
- Urodynamically diagnosed detrusor overactivity
- The strength of pelvic floor muscle 3/5 and more
- 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 QoL questionnaire
Who cannot join
- History of conservative therapy (BT, ES) for OAB within 3 months
- Previously treated with antimuscarinics (within 4 weeks)
- 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
- Having stage 2 or more 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 residual urine volume more than 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: Bladder Training With and Without Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder: A Prospective Randomised Controlled Trial
Overactive bladder (OAB) is a symptom complex defined as urgency, with or without urge urinary incontinence (UUI), usually with frequency and nocturia, in the absence of urinary tract infection. Currently, a wide range of therapeutic options exist for the treatment of OAB. These include first-line conservative (physical) therapies which focus on electrical stimulation (ES) and behavioral therapies such as lifestyle modifications, bladder training (BT), pelvic floor muscle training with or without biofeedback, second-line therapies which are pharmacologic, and third-line therapies which either neuromodulate or chemodenervate the bladder.
In clinical practice, BT and Intravaginal ES (IVES) are frequently used together in the treatment of women with OAB, but the evidences/results of the combined (BT+IVES) use of these two treatment options are so rare that they can be neglected in the literature. There is only one study including BT+ES treatment arm (one of the four treatment arms) in women with idiopathic OAB in the literature. In a study, BT+ES was not found to be effective both from BT alone and from the untreated control group. While interpreting the results of this study, it should be take into consideration that patients treated received relatively few treatment sessions (nine treatment sessions, once weekly) in this study. In addition, in the light of authors clinical experience, the investigators think that this issue is still open for research. Moreover, there is no recommendation on conservative combinations in the guidelines due to insufficient data.
This study is the first prospective randomized controlled trial that compares the efficacy of BT and BT plus IVES in women with idiopathic OAB. In this study, the investigators aimed to evaluate the efficacy of BT with and without IVES on incontinence-related QoL and clinical parameters in women with idiopathic OAB.
- Being tested
- Electrical stimulation (IVES), Bladder Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulation (IVES)Other
IVES sessions were performed three times in a week, for 8 weeks. Every session lasted 20 minutes. The intervention comprised a 24 session treatment program of IVES.
Bladder TrainingOther
Bladder Training
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Bladder Training - Control group | Other | Specific goals are to correct faulty habit patterns of frequent urination, improve control over bladder urgency, prolong voiding intervals, increase bladder capacity, reduce incontinence episodes and restore patient confidence in controlling bladder function Receives: Other: Bladder Training |
| Group 2: Bladder Training+Intra Vaginal Electrical Stimulation | Active comparator | IVES was performed in lithotomy position via Enraf Nonius Myomed 632 device with a vaginal probe. IVES sessions were performed three times in a week, for 8 weeks. Every session lasted 20 minutes. The intervention comprised a 24-session 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 Receives: Other: Electrical stimulation (IVES); Other: Bladder Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
incontinence episodes-incontinence related outcomes measures
Patients with a 50% or greater reduction in incontinence episodes were consider positive responders (number of voiding per day)
Measured: 8 weeks
Secondary outcomes (3)
frequency of voiding-incontinence related outcomes measures
it was used frequency from data with a bladder diary (number of voiding per day)
Measured: 8 weeks
nocturia frequency- incontinence related outcomes measures
it was used nocturia from data with a bladder diary (number of voiding per night)
Measured: 8 weeks
incontinence related quality of life questionnaire
(IIQ-7) (score)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 Jun 2020
- Primary completion1 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Overactive BladderStudies 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
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Alkan, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389307
- Sponsor's protocol ID
- 19892010-2019
- Status last verified
- May 2021
- First submitted
- 12 May 2020
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Training With and Without Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder: A Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04389307
- Acronym / sponsor ID
- 19892010-2019
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 May 2020 (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.
Overactive bladder (OAB) is a symptom complex defined as urgency, with or without urge urinary incontinence (UUI), usually with frequency and nocturia, in the absence of urinary tract infection. Currently, a wide range of therapeutic options exist for the treatment of OAB. These include first-line conservative (physical) therapies which focus on electrical stimulation (ES) and behavioral therapies such as lifestyle modifications, bladder training (BT), pelvic floor muscle training with or without biofeedback, second-line therapies which are pharmacologic, and third-line therapies which either neuromodulate or chemodenervate the bladder.
In clinical practice, BT and Intravaginal ES (IVES) are frequently used together in the treatment of women with OAB, but the evidences/results of the combined (BT+IVES) use of these two treatment options are so rare that they can be neglected in the literature. There is only one study including BT+ES treatment arm (one of the four treatment arms) in women with idiopathic OAB in the literature. In a study, BT+ES was not found to be effective both from BT alone and from the untreated control group. While interpreting the results of this study, it should be take into consideration that patients treated received relatively few treatment sessions (nine treatment sessions, once weekly) in this study. In addition, in the light of authors clinical experience, the investigators think that this issue is still open for research. Moreover, there is no recommendation on conservative combinations in the guidelines due to insufficient data.
This study is the first prospective randomized controlled trial that compares the efficacy of BT and BT plus IVES in women with idiopathic OAB. In this study, the investigators aimed to evaluate the efficacy of BT with and without IVES on incontinence-related QoL and clinical parameters in women with idiopathic OAB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Bladder Training - Control group | Other | Other: Bladder TrainingSpecific goals are to correct faulty habit patterns of frequent urination, improve control over bladder urgency, prolong voiding intervals, increase bladder capacity, reduce incontinence episodes and restore patient confidence in controlling bladder function |
| Group 2: Bladder Training+Intra Vaginal Electrical Stimulation | Active comparator | Other: Electrical stimulation (IVES), Other: Bladder TrainingIVES was performed in lithotomy position via Enraf Nonius Myomed 632 device with a vaginal probe. IVES sessions were performed three times in a week, for 8 weeks. Every session lasted 20 minutes. The intervention comprised a 24-session 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 |
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 over the age of 18 with clinical diagnosis of idiopathic OAB
- Urodynamically diagnosed detrusor overactivity
- The strength of pelvic floor muscle 3/5 and more
- Able to give written, informed consent
- Able to understand the procedures, advantages and possible side effects
Key exclusion criteria (11 listed)
- History of conservative therapy (BT, ES) for OAB within 3 months
- Previously treated with antimuscarinics (within 4 weeks)
- 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 |
|---|---|---|
| Electrical stimulation (IVES)IVES sessions were performed three times in a week, for 8 weeks. Every session lasted 20 minutes. The intervention comprised a 24 session treatment program of IVES. | Other | Group 2: Bladder Training+Intra Vaginal Electrical Stimulation |
| Bladder TrainingBladder Training | Other | Group 1: Bladder Training - Control group, Group 2: Bladder Training+Intra Vaginal Electrical Stimulation |
Primary outcome
incontinence episodes-incontinence related outcomes measures
Time frame: 8 weeks
Patients with a 50% or greater reduction in incontinence episodes were consider positive responders (number of voiding per day)
3 secondary outcomes
frequency of voiding-incontinence related outcomes measures
Time frame: 8 weeks
nocturia frequency- incontinence related outcomes measures
Time frame: 8 weeks
incontinence related quality of life questionnaire
Time frame: 8 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 25 May 2021.
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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 Electrical stimulation (IVES) and Bladder Training in people with Idiopathic Overactive Bladder and Electrical Stimulation, 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 25 May 2021. 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 outcomes measures (time frame: 8 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 25 May 2021.