Clinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

The aim of the study is to assess the association between bladder sensations progression during bladder filling and severity of Overactive bladder (OAB) in patients with multiple sclerosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18

MS according to the 2017 Mac Donald diagnostic criteria

Bladder disorders supposedly related to MS

Indication to perform urodynamics

Disqualifiers

Legal protection

Pregnancy or breastfeeding mother

MS relapse during the past month

Other associated neurological disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Repeated cystometries with bladder sensations assessment

    Procedure/Surgery

    A second cystometry will be performed to assess bladder sensations reliability. A third cystometry with cognitive task (STROOP test) at the same time will be performed to assess the impact of distractive attentional task on bladder sensations

Treatment groups

113 Participants
are divided into 1 treatment group
Group A: MS Patient with Bladder disordersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

bladder sensation ( area under the sensation-capacity curve (AUC))

The areas under the sensation-capacity curve (AUC) will be calculated for individual participants using the trapezoidal rule for specific capacity ranges.

Time frame
Day 1

Secondary outcomes

1

bladder sensitivity

Bladder sensitivity assessed by the number of steps in the evolution of the need to urinate reported by the patient (number of times the cursor of the analogical scale is moved), during the filling.

Time frame
Day 1

Other outcomes

Sponsors and contacts

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