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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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.


Condition or disease Intervention/treatment
iOAB= Idiopathic Overactive Bladder Other: Physical activity Other: Absence of or suspended physical activity

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. ryhthm of physical activity sessions [ Time Frame: 3 months ]
  2. Number of physical activity sessions [ Time Frame: 3 months ]
  3. Location of sessions [ Time Frame: 3 months ]
  4. Quality of life score [ Time Frame: Change from basline quality of life at 3 months ]
  5. Evolution of Discomfort related to urinary disorder [ Time Frame: Change from baseline discomfort related to urinary disorder at 3 months ]
  6. Number of urinations per 24 hours [ Time Frame: Change from baseline number of urinations per 24 hours at 3 months ]
  7. Number of incontinence episodes per 24 hours [ Time Frame: Change from baseline number of incontinence episodes per 24 hours at 3 months ]
  8. OAB Sub-scores on the PSU questionnaire [ Time Frame: Change from baseline OAB Sub-scores on the PSU questionnaire at 3 months ]
  9. Drinking habits according to the urination calendar [ Time Frame: Change from baseline drinking habits at 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with idiopathic overactive bladder
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

Information from the National Library of Medicine

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


Contacts
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Contact: Véronique BONNIAUD 0380293800 veronique.bonniaud@chu-dijon.fr

Locations
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France
Chu Dijon Bourogne Recruiting
Dijon, France, 21000
Contact: Véronique BONNIAUD    0380293800    veronique.bonniaud@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03552172     History of Changes
Other Study ID Numbers: BUCHOT 2017
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms