Clinical trial NCT03552172: 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
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: iOAB= Idiopathic Overactive Bladder
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with idiopathic overactive bladder

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: ryhthm of physical activity sessions
timeFrame: 3 months
measure: Number of physical activity sessions
timeFrame: 3 months
measure: Location of sessions
timeFrame: 3 months
measure: Quality of life score
timeFrame: Change from basline quality of life at 3 months
measure: Evolution of Discomfort related to urinary disorder
timeFrame: Change from baseline discomfort related to urinary disorder at 3 months
measure: Number of urinations per 24 hours
timeFrame: Change from baseline number of urinations per 24 hours at 3 months
measure: Number of incontinence episodes per 24 hours
timeFrame: Change from baseline number of incontinence episodes per 24 hours at 3 months
measure: OAB Sub-scores on the PSU questionnaire
timeFrame: Change from baseline OAB Sub-scores on the PSU questionnaire at 3 months
measure: Drinking habits according to the urination calendar
timeFrame: Change from baseline drinking habits at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References: