iOAB= Idiopathic Overactive Bladder Clinical Trial
— HAV-APOfficial 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
| NCT number | NCT03552172 |
| Other study ID # | BUCHOT 2017 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 23, 2018 |
| Est. completion date | March 2019 |
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | March 2019 |
| Est. primary completion date | March 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Chu Dijon Bourogne | Dijon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Dijon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | ryhthm of physical activity sessions | 3 months | ||
| Primary | Number of physical activity sessions | 3 months | ||
| Primary | Location of sessions | 3 months | ||
| Primary | Quality of life score | Change from basline quality of life at 3 months | ||
| Primary | Evolution of Discomfort related to urinary disorder | Change from baseline discomfort related to urinary disorder at 3 months | ||
| Primary | Number of urinations per 24 hours | Change from baseline number of urinations per 24 hours at 3 months | ||
| Primary | Number of incontinence episodes per 24 hours | Change from baseline number of incontinence episodes per 24 hours at 3 months | ||
| Primary | OAB Sub-scores on the PSU questionnaire | Change from baseline OAB Sub-scores on the PSU questionnaire at 3 months | ||
| Primary | Drinking habits according to the urination calendar | Change from baseline drinking habits at 3 months |