Overactive BladderNCT01409512
Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder
An observational study of Overactive Bladder, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The aim of the study is to evaluate changes in autonomic nervous system following treatment with anticholinergic medication for OAB symptoms. Heart variability as a measure of the functioning of the autonomic nervous system will be recorded before and three months following treatment with solifenacin succinate 10 mg… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- ECG recording
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2011to Sep 2013
- Phase
- Observational
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients were diagnosed as having OAB syndrome by an urogynecologist based on their clinical symptoms (urinary urgency, with or without urinary urgency incontinence, urinary frequency or nocturia).
Who may be able to join
- Clinical diagnosis of OAB
Who cannot join
- 1) stress urinary incontinence and voiding symptoms, 2) pregnancy, 3) pathological conditions that can interfere with the ANS, (e.g. coronary heart disease, heart failure, or other cardiac conditions, hypertension, neurological diseases or diabetes , 4) medications that can interfere with the ANS, including beta-receptor agonists or antagonists, antiarrhythmic agents or antihypertensive drugs, anticholinergic agents or adrenergic alpha-antagonists, tricyclic or serotoninergic antidepressants.
Trial locations and contacts
1 site in 1 country.
Dalia Kesner, MD contact
Israel1 site
Zvolon Medical Center
Haifa, 34987
Lior Lowenstein, MD, 97248542612, LowensteinMD@gmail.com
Dalia Kesner, MD
About this study
Official title: Observational Study on the Effect of Anticholinergic on the Autonomic System in Women With OAB
The aim of the study is to evaluate changes in autonomic nervous system following treatment with anticholinergic medication for OAB symptoms.
Heart variability as a measure of the functioning of the autonomic nervous system will be recorded before and three months following treatment with solifenacin succinate 10 mg daily.
Read the detailed description
30 women with clinical diagnosis of overactive bladder will be recruited for the study. An ECG strip for fifteen minutes at rest will be recorded through a 12-bit analog/digital data acquisition card (National Instruments, Austin TX) with a sampling frequency of 200 Hz and stored in a computer for offline studies. The digitized ECG signals will than processed and analyzed via dedicated robust software to detect the R wave peaks. The R point of each QRS complex was defined and the interval between two consecutive R points (the R-R interval) was computed. All R-R intervals will be visually inspected and manually edited if necessary to exclude background noise and artifacts. The edited segments accounts for less than 1% in each patient. A "clean" 2-5-min segment (preferably unedited) will be used for the analyses. An autoregressive model with the order of 16 was will be used to estimate the power spectrum densities of HRV. The power spectra are quantified by measuring the area under the following frequency bands: low-frequency (LF) (0.04-0.15 Hz) known to represents sympathetic activity, and high-frequency (HF) (0.15-0.4 Hz) which represents parasympathetic activity.
- Conditions
- Overactive Bladder
- Being tested
- ECG recording
- Keywords
- Heart rate variability, anti cholinergic medication
- 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.
ECG recordingProcedure or surgery
Also called Electro cardiogram recording
At baseline and following 3 months on anticholinergic medications patients, ECG recording will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| Women with OAB | Patients that will be diagnosed as having OAB syndrome by an urogynecologist based on their clinical symptoms (urinary urgency, with or without urinary urgency incontinence, urinary frequency or nocturia). Receives: Procedure: ECG recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in heart variability following treatment with Solifenacin succinate 10 mg
Measured: 24 months
Secondary outcomes (1)
Correlation between changes in clinical symptoms of OAB abd changes in heart rate variability
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Lior Lowensrtein, MD, Study chair, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409512
- Sponsor's protocol ID
- 117/2011
- Status last verified
- Aug 2011
- First submitted
- 3 Aug 2011
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Mehnert U, Knapp PA, Mueller N, Reitz A, Schurch B. Heart rate variability: an objective measure of autonomic activity and bladder sensations during urodynamics. Neurourol Urodyn. 2009;28(4):313-9. doi: 10.1002/nau.20641.
PubMed 19058189Liao WC, Jaw FS. A noninvasive evaluation of autonomic nervous system dysfunction in women with an overactive bladder. Int J Gynaecol Obstet. 2010 Jul;110(1):12-7. doi: 10.1016/j.ijgo.2010.03.007. Epub 2010 Apr 25.
PubMed 20423739Schiffers M, Sauermann P, Schurch B, Mehnert U. The effect of tolterodine 4 and 8 mg on the heart rate variability in healthy subjects. World J Urol. 2010 Oct;28(5):651-6. doi: 10.1007/s00345-010-0513-y. Epub 2010 Feb 7.
PubMed 20140437Hubeaux K, Deffieux X, Ismael SS, Raibaut P, Amarenco G. Autonomic nervous system activity during bladder filling assessed by heart rate variability analysis in women with idiopathic overactive bladder syndrome or stress urinary incontinence. J Urol. 2007 Dec;178(6):2483-7. doi: 10.1016/j.juro.2007.08.036. Epub 2007 Oct 15.
PubMed 17937953
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Effect of Anticholinergic on the Autonomic System in Women With OAB
- ClinicalTrials.gov ID
- NCT01409512
- Acronym / sponsor ID
- 117/2011
- Conditions
- Overactive Bladder
- Keywords
- Heart rate variability, anti cholinergic medication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 4 Aug 2011 (estimated)
- 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 the study is to evaluate changes in autonomic nervous system following treatment with anticholinergic medication for OAB symptoms.
Heart variability as a measure of the functioning of the autonomic nervous system will be recorded before and three months following treatment with solifenacin succinate 10 mg daily.
Detailed description
30 women with clinical diagnosis of overactive bladder will be recruited for the study. An ECG strip for fifteen minutes at rest will be recorded through a 12-bit analog/digital data acquisition card (National Instruments, Austin TX) with a sampling frequency of 200 Hz and stored in a computer for offline studies. The digitized ECG signals will than processed and analyzed via dedicated robust software to detect the R wave peaks. The R point of each QRS complex was defined and the interval between two consecutive R points (the R-R interval) was computed. All R-R intervals will be visually inspected and manually edited if necessary to exclude background noise and artifacts. The edited segments accounts for less than 1% in each patient. A "clean" 2-5-min segment (preferably unedited) will be used for the analyses. An autoregressive model with the order of 16 was will be used to estimate the power spectrum densities of HRV. The power spectra are quantified by measuring the area under the following frequency bands: low-frequency (LF) (0.04-0.15 Hz) known to represents sympathetic activity, and high-frequency (HF) (0.15-0.4 Hz) which represents parasympathetic activity.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with OAB | – | Procedure: ECG recordingPatients that will be diagnosed as having OAB syndrome by an urogynecologist based on their clinical symptoms (urinary urgency, with or without urinary urgency incontinence, urinary frequency or nocturia). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were diagnosed as having OAB syndrome by an urogynecologist based on their clinical symptoms (urinary urgency, with or without urinary urgency incontinence, urinary frequency or nocturia).
Key inclusion criteria (1 listed)
- Clinical diagnosis of OAB
Key exclusion criteria (1 listed)
- 1) stress urinary incontinence and voiding symptoms, 2) pregnancy, 3) pathological conditions that can interfere with the ANS, (e.g. coronary heart disease, heart failure, or other cardiac conditions, hypertension, neurological diseases or diabetes , 4) medications that can interfere with the ANS, including beta-receptor agonists or antagonists, antiarrhythmic agents or antihypertensive drugs, anticholinergic agents or adrenergic alpha-antagonists, tricyclic or serotoninergic antidepressants.
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 |
|---|---|---|
| ECG recordingAlso: Electro cardiogram recordingAt baseline and following 3 months on anticholinergic medications patients, ECG recording will be conducted. | Procedure or surgery | Women with OAB |
Primary outcome
Changes in heart variability following treatment with Solifenacin succinate 10 mg
Time frame: 24 months
1 secondary outcome
Correlation between changes in clinical symptoms of OAB abd changes in heart rate variability
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
- Background: PubMed 19058189Mehnert U, Knapp PA, Mueller N, Reitz A, Schurch B. Heart rate variability: an objective measure of autonomic activity and bladder sensations during urodynamics. Neurourol Urodyn. 2009;28(4):313-9. doi: 10.1002/nau.20641.
- Background: PubMed 20423739Liao WC, Jaw FS. A noninvasive evaluation of autonomic nervous system dysfunction in women with an overactive bladder. Int J Gynaecol Obstet. 2010 Jul;110(1):12-7. doi: 10.1016/j.ijgo.2010.03.007. Epub 2010 Apr 25.
- Background: PubMed 20140437Schiffers M, Sauermann P, Schurch B, Mehnert U. The effect of tolterodine 4 and 8 mg on the heart rate variability in healthy subjects. World J Urol. 2010 Oct;28(5):651-6. doi: 10.1007/s00345-010-0513-y. Epub 2010 Feb 7.
- Background: PubMed 17937953Hubeaux K, Deffieux X, Ismael SS, Raibaut P, Amarenco G. Autonomic nervous system activity during bladder filling assessed by heart rate variability analysis in women with idiopathic overactive bladder syndrome or stress urinary incontinence. J Urol. 2007 Dec;178(6):2483-7. doi: 10.1016/j.juro.2007.08.036. Epub 2007 Oct 15.
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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.
Dalia Kesner, MD contact
Lior Lowensrtein, MD study chair
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by Rambam Health Care Campus at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 4 Aug 2011. 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 Israel. 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 Dalia Kesner, MD (DALIAKE@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in heart variability following treatment with Solifenacin succinate 10 mg (time frame: 24 months). 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 NCT01409512, which also lists 4 linked publications.
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 4 Aug 2011.