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)

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 Overview

• Status: Unknown
• Conditions: iOAB= Idiopathic Overactive Bladder
• Intervention / Treatment: Other: Physical activity; Other: Absence of or suspended physical activity

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • Chu Dijon Bourogne
    • Contact: Véronique BONNIAUD; Phone Number: 0380293800; Email: veronique.bonniaud@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with idiopathic overactive bladder

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ryhthm of physical activity sessions	3 months
Number of physical activity sessions	3 months
Location of sessions	3 months
Quality of life score	Change from basline quality of life at 3 months
Evolution of Discomfort related to urinary disorder	Change from baseline discomfort related to urinary disorder at 3 months
Number of urinations per 24 hours	Change from baseline number of urinations per 24 hours at 3 months
Number of incontinence episodes per 24 hours	Change from baseline number of incontinence episodes per 24 hours at 3 months
OAB Sub-scores on the PSU questionnaire	Change from baseline OAB Sub-scores on the PSU questionnaire at 3 months
Drinking habits according to the urination calendar	Change from baseline drinking habits at 3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 23, 2018
• Primary Completion (ANTICIPATED): March 1, 2019
• Study Completion (ANTICIPATED): March 1, 2019

Study Registration Dates

• First Submitted: April 27, 2018
• First Submitted That Met QC Criteria: May 29, 2018
• First Posted (ACTUAL): June 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: BUCHOT 2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No