iOAB= Idiopathic Overactive BladderHAV-APNCT03552172
Retrospective Study of Prescribed Physical Activity in Patients With Overactive Bladder Syndrome Monitored Within the Pelvi-perineology Network in Dijon: Evaluation of Prescription Compliance and Impact on Quality of Life
An observational study of iOAB= Idiopathic Overactive Bladder, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Overactive bladder (OAB) is a clinical syndrome defined by the International Continence Society (ICS) and the International Urogynecological Association (IUGA) as urinary urgency (sudden and uncontrollable urge to urinate) possibly associated with urinary frequency (urination greater than 8 times per day), nocturia (2… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- iOAB= Idiopathic Overactive Bladder
- What is being tested?
- Physical activity and Absence of or suspended physical activity
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2018to Mar 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with idiopathic overactive bladder
Who may be able to join
- Male or female over 18 years of age with iOAB
- The presence of iOAB defined as a positive response (yes, several times a week or several times a day) to the question "how many times in the past 4 weeks have you had to rush to the bathroom to urinate because of an urgent need?
- Treatment unsuccessful or insufficient improvement with discomfort related to OAB on EN>5 by 1st or 2nd line treatments (anticholinergic, alpha-blocker, peripheral neuromodulation by urostim)
- Treatment not changed for 3 months or stopped for at least 4 weeks
Who cannot join
- Patients with pure stress urinary incontinence or predominantly stress mixed incontinence
- Subjects with neurological diseases (multiple sclerosis, Parkinson's...)
- Subjects with acute urinary tract infection
- Subjects with post micturition residue > 150 mL
- Subjects with untreated bladder obstruction
- Subjects with prolapse grade ≥ 3
Show all 11Show fewer
- Subjects with painful bladder syndrome
- Subjects who received chemotherapy or radiation therapy
- Subjects conducting self-surveys
- Subjects with cardiovascular factors whose exercise training is not authorized by the cardiologist
- Pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourogne
Dijon, 21000
Véronique BONNIAUD, 0380293800, veronique.bonniaud@chu-dijon.fr
About this study
Overactive bladder (OAB) is a clinical syndrome defined by the International Continence Society (ICS) and the International Urogynecological Association (IUGA) as urinary urgency (sudden and uncontrollable urge to urinate) possibly associated with urinary frequency (urination greater than 8 times per day), nocturia (2 or more urinations per night) or urinary incontinence (UI). In most cases no root cause is found, so it is referred to as idiopathic overactive bladder (iOAB).
The treatment of iOAB is based primarily on hygiene and dietary measures and perineal rehabilitation. If these are insufficient, medical anticholinergic treatment is offered.
Read more
Second-line therapies are based on percutaneous neuromodulation of the tibial nerve, neuromodulation of the sacral roots S3 and intra-detrusor injection of botulinum-A toxin.
iOAB has a significant negative impact on patients' quality of life, particularly in cases of associated urinary incontinence. It is at the origin of low self confidence.
A significant proportion of patients with iOAB are not managed or are not satisfied with treatment.
A strong epidemiological correlation between AVH and metabolic syndrome (MS) was demonstrated in a literature review of 119 articles. MS is a clinical-biological syndrome defined by the National Cholesterol Education Program Adut Treatment Panel III (NCEP ATP III). The prevalence of OAB increases with that of obesity but only from a waist circumference of at least 100cm. S. Boudokhane showed in a prospective study of 34 patients with MS defined by the NCEP ATP III criteria that waist circumference, BMI and post prandial glucose were positively correlated with the presence of OAB measured by the PSU score (p<0.05).
Physical activity (PA) is defined as any body movement produced by skeletal muscles resulting in a substantial increase in energy expenditure above rest energy expenditure (WHO). The efficacy of AP on MS has been demonstrated in primary prevention and treatment of MS by the HERITAGE study and the controlled trial established under the Diabetes Prevention Program (DPP). The follow-up was conducted over 3.2 years and showed a significant decrease in the incidence of MS in the PA group by 41% compared to placebo (p<0.001). The action of PA on iOAB has not been directly studied but some studies have shown that PA and pelvic floor muscle strengthening significantly and respectively decrease the number of mixed (p< 0.0001) (14) or urgency (p=0.009) UI episodes. Since March 2017, the prescription of modified PA is possible.
- Conditions
- iOAB= Idiopathic Overactive Bladder
- Being tested
- Physical activity, Absence of or suspended physical activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
PHYSICAL ACTIVITY: Rhythm of meetings, number of meetings, place of meetings
Absence of or suspended physical activityOther
the brakes responsible for a stop or lack of practice
| Study group | Role | What they receive |
|---|---|---|
| Prescription physical activity | Not described Receives: Other: Physical activity | |
| No prescription for physical activity or suspension | Not described Receives: Other: Absence of or suspended physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
ryhthm of physical activity sessions
Measured: 3 months
Number of physical activity sessions
Measured: 3 months
Location of sessions
Measured: 3 months
Quality of life score
Measured: Change from basline quality of life at 3 months
Evolution of Discomfort related to urinary disorder
Measured: Change from baseline discomfort related to urinary disorder at 3 months
Number of urinations per 24 hours
Measured: Change from baseline number of urinations per 24 hours at 3 months
Number of incontinence episodes per 24 hours
Measured: Change from baseline number of incontinence episodes per 24 hours at 3 months
OAB Sub-scores on the PSU questionnaire
Measured: Change from baseline OAB Sub-scores on the PSU questionnaire at 3 months
Drinking habits according to the urination calendar
Measured: Change from baseline drinking habits at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start23 Feb 2018
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for iOAB= Idiopathic Overactive BladderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552172
- Sponsor's protocol ID
- BUCHOT 2017
- Acronym
- HAV-AP
- Status last verified
- Apr 2018
- First submitted
- 27 Apr 2018
- Last updated
- 11 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Prescribed Physical Activity in Patients With Overactive Bladder Syndrome Monitored Within the Pelvi-perineology Network in Dijon: Evaluation of Prescription Compliance and Impact on Quality of Life
- ClinicalTrials.gov ID
- NCT03552172
- Acronym / sponsor ID
- HAV-AP / BUCHOT 2017
- Conditions
- iOAB= Idiopathic Overactive Bladder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 11 Jun 2018 (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 clinical syndrome defined by the International Continence Society (ICS) and the International Urogynecological Association (IUGA) as urinary urgency (sudden and uncontrollable urge to urinate) possibly associated with urinary frequency (urination greater than 8 times per day), nocturia (2 or more urinations per night) or urinary incontinence (UI). In most cases no root cause is found, so it is referred to as idiopathic overactive bladder (iOAB).
The treatment of iOAB is based primarily on hygiene and dietary measures and perineal rehabilitation. If these are insufficient, medical anticholinergic treatment is offered.
Second-line therapies are based on percutaneous neuromodulation of the tibial nerve, neuromodulation of the sacral roots S3 and intra-detrusor injection of botulinum-A toxin.
iOAB has a significant negative impact on patients' quality of life, particularly in cases of associated urinary incontinence. It is at the origin of low self confidence.
A significant proportion of patients with iOAB are not managed or are not satisfied with treatment.
A strong epidemiological correlation between AVH and metabolic syndrome (MS) was demonstrated in a literature review of 119 articles. MS is a clinical-biological syndrome defined by the National Cholesterol Education Program Adut Treatment Panel III (NCEP ATP III). The prevalence of OAB increases with that of obesity but only from a waist circumference of at least 100cm. S. Boudokhane showed in a prospective study of 34 patients with MS defined by the NCEP ATP III criteria that waist circumference, BMI and post prandial glucose were positively correlated with the presence of OAB measured by the PSU score (p<0.05).
Physical activity (PA) is defined as any body movement produced by skeletal muscles resulting in a substantial increase in energy expenditure above rest energy expenditure (WHO). The efficacy of AP on MS has been demonstrated in primary prevention and treatment of MS by the HERITAGE study and the controlled trial established under the Diabetes Prevention Program (DPP). The follow-up was conducted over 3.2 years and showed a significant decrease in the incidence of MS in the PA group by 41% compared to placebo (p<0.001). The action of PA on iOAB has not been directly studied but some studies have shown that PA and pelvic floor muscle strengthening significantly and respectively decrease the number of mixed (p< 0.0001) (14) or urgency (p=0.009) UI episodes. Since March 2017, the prescription of modified PA is possible.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prescription physical activity | – | Other: Physical activity |
| No prescription for physical activity or suspension | – | Other: Absence of or suspended physical activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with idiopathic overactive bladder
Key inclusion criteria (4 listed)
- Male or female over 18 years of age with iOAB
- The presence of iOAB defined as a positive response (yes, several times a week or several times a day) to the question "how many times in the past 4 weeks have you had to rush to the bathroom to urinate because of an urgent need?
- Treatment unsuccessful or insufficient improvement with discomfort related to OAB on EN>5 by 1st or 2nd line treatments (anticholinergic, alpha-blocker, peripheral neuromodulation by urostim)
- Treatment not changed for 3 months or stopped for at least 4 weeks
Key exclusion criteria (11 listed)
- Patients with pure stress urinary incontinence or predominantly stress mixed incontinence
- Subjects with neurological diseases (multiple sclerosis, Parkinson's...)
- Subjects with acute urinary tract infection
- Subjects with post micturition residue > 150 mL
- Subjects with untreated bladder obstruction
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 |
|---|---|---|
| Physical activityPHYSICAL ACTIVITY: Rhythm of meetings, number of meetings, place of meetings | Other | Prescription physical activity |
| Absence of or suspended physical activitythe brakes responsible for a stop or lack of practice | Other | No prescription for physical activity or suspension |
Primary outcome
ryhthm of physical activity sessions
Time frame: 3 months
Number of physical activity sessions
Time frame: 3 months
Location of sessions
Time frame: 3 months
Quality of life score
Time frame: Change from basline quality of life at 3 months
Evolution of Discomfort related to urinary disorder
Time frame: Change from baseline discomfort related to urinary disorder at 3 months
Number of urinations per 24 hours
Time frame: Change from baseline number of urinations per 24 hours at 3 months
Number of incontinence episodes per 24 hours
Time frame: Change from baseline number of incontinence episodes per 24 hours at 3 months
OAB Sub-scores on the PSU questionnaire
Time frame: Change from baseline OAB Sub-scores on the PSU questionnaire at 3 months
Drinking habits according to the urination calendar
Time frame: Change from baseline drinking habits at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
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.
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 iOAB= Idiopathic Overactive Bladder, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 4 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: status not confirmed, as of the sponsor's last update on 11 Jun 2018. 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 France. 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 Véronique BONNIAUD (0380293800, veronique.bonniaud@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ryhthm of physical activity sessions (time frame: 3 months). The study lists 9 primary outcomes in all. 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 11 Jun 2018.