French Study to Evaluate the Impact of a Cognitive Therapy on Urinary Incontinent Women of All Age's Perineal Settings.

Summary

This trial is a pathophysiological study evaluating the impact of a cognitive therapy on the perineal neuromuscular mechanisms in women patients with urinary incontinence.

Some research works have been realized on the impact of a cognitive load test (CLT) on the neuromuscular continence urinary mechanisms. It had been demonstrated that a CLT induced an increase in the latency of voluntary perineal contraction. It had also been demonstrated that a CLT had an influence on the involuntary perineal contraction pre-activation. Most recently, the impact of a cognitive therapy on the perineal neuromuscular mechanisms on healthy participants had been evaluated. It demonstrated that a cognitive therapy inhibited the impact of the CLT on the perineal neuromuscular mechanisms.

The present project is about the evaluation of the interest of a cognitive therapy on the neuromuscular mechanisms in case of attentional test in a urinary incontinent women population. It could conduce to new therapeutic leads for the management of urinary incontinence.

Conditions

• Urinary Incontinence, Stress
• Urinary Incontinence, Urge

Interventions

OTHER

Classical rehabilitation

Participants will benefit from two-phases perineal rehabilitation: First phase will include the PFM's awareness and voluntary contraction learning with manual, biofeedback technics and functional electro stimulation. These exercises will call out the manual rehabilitation technics, biofeedback and electro stimulation. Each classical rehabilitation session will take 30 minutes with 20 minutes of active working, twice per week. About the self-training, there will be no consensus for optimal homemade exercises. For the second phase, a behavior analyze will be summarized in order to update the favoring and inappropriate situations. The strategy put in place will be organized in unlearning of deleterious perineal habits and learning new behavior program. The main goal will be the perineal locking set up, which must be systematic before and during efforts. During this phase, the physiotherapist will twice weekly perform evaluations (similar to those in the first phase)

BEHAVIORAL

Cognitive associated rehabilitation

The cognitive associated rehabilitation group randomized participants will have to execute twice a day the rehabilitation protocol. Each cognitive rehabilitation session will take three minutes. Participants will have to synergistically execute attentional tests (N-Back Test) and execute a perineal contraction during the contraction instructions. (10 randomized auditory stimuli in three minutes). The attentional tests' difficulty will be gradually increased each 15 days. N-Back Test modalities are the followings: the participant will visualize a series of random numbers. First difficulty step will be to click the dedicated button when the volunteer will see the indicated letter. The second difficulty step will be to click the dedicated button when she will see two consecutives times the same letter. The third difficulty step will be to click the dedicated button when she will see two times the same letter separated by one different letter, and so on…

Sponsors & Collaborators

• APHP

  collaborator OTHER

• Pierre and Marie Curie University

  lead OTHER

Principal Investigators

• Thibault THUBERT, MD · CHU Hotel Dieu Nantes

• Pierre-André MAL, resident · CHU Hopital Tenon APHP

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-10

Primary Completion

2019-07-31

Completion

2019-07-31