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 (HAV-AP)
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|ClinicalTrials.gov Identifier: NCT03552172|
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : June 11, 2018
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.
|Condition or disease||Intervention/treatment|
|iOAB= Idiopathic Overactive Bladder||Other: Physical activity Other: Absence of or suspended physical activity|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
|Actual Study Start Date :||February 23, 2018|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
|Prescription physical activity||
Other: Physical activity
PHYSICAL ACTIVITY: Rhythm of meetings, number of meetings, place of meetings
|No prescription for physical activity or suspension||
Other: Absence of or suspended physical activity
the brakes responsible for a stop or lack of practice
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552172
|Contact: Véronique BONNIAUDemail@example.com|
|Chu Dijon Bourogne||Recruiting|
|Dijon, France, 21000|
|Contact: Véronique BONNIAUD 0380293800 firstname.lastname@example.org|