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

NCT03797365 | Unknown

• 1 other identifier: cpp17-065a/2016-A01651-50
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• RT3 - EMG Latency between intercostal muscles contraction and perineal muscles contraction

  EMG Latency between intercostal muscles contraction and perineal muscles contraction

  Final evaluation at the eighth week follow up

• RT3 - EMG Latency between intercostal muscles contraction and perineal muscles

  EMG Latency between intercostal muscles contraction and perineal muscles contraction

  Intermediary evaluation at the fourth week follow up

Secondary Outcomes (4)

• RT1 - EMG Latency between stimulus and perineal muscles contraction

  Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up

• Urinary Handicap Measurement (Mesure du Handicap Urinaire - MHU)

  Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up

• International Consultation on Incontinence Questionnaire (ICIQ-SF)

  Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up

• Questionnaire for assessment of quality of life related to women urinary incontinence (Contilife)

  Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up

Study Arms (2)

Classical rehabilitation

ACTIVE COMPARATOR

Twenty women will benefit from two-phases perineal rehabilitation: first phase pelvic floor muscles (PFM)'s analytic rehabilitation, then a functional rehabilitation.

Other: Classical rehabilitation

Classical and cognitive associated rehabilitation

EXPERIMENTAL

Twenty women will receive, added to the classic perineal rehabilitation, the cognitive rehabilitation and will have to execute twice a day the rehabilitation protocol.

Behavioral: Cognitive associated rehabilitation

Interventions

Classical rehabilitation OTHER

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)

Classical rehabilitation

Cognitive associated rehabilitation BEHAVIORAL

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…

Classical and cognitive associated rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major women with stress urinary incontinence or mixed urinary incontinence or urge urinary incontinence, in need to benefit from perineal rehabilitation or cognitive-behavioral rehabilitation
• Women able to read, understand, accept and sign the consent.

You may not qualify if:

• Pregnant women,
• Refusal to participate
• Dementia and cognitive troubles (MMS\<30).

Sponsors & Collaborators

• Pierre and Marie Curie University: lead
• APHP: collaborator

Related Publications (13)

• Sapsford RR, Hodges PW. Contraction of the pelvic floor muscles during abdominal maneuvers. Arch Phys Med Rehabil. 2001 Aug;82(8):1081-8. doi: 10.1053/apmr.2001.24297.

  PMID: 11494188 BACKGROUND

• Amarenco G, Ismael SS, Lagauche D, Raibaut P, Rene-Corail P, Wolff N, Thoumie P, Haab F. Cough anal reflex: strict relationship between intravesical pressure and pelvic floor muscle electromyographic activity during cough. Urodynamic and electrophysiological study. J Urol. 2005 Jan;173(1):149-52. doi: 10.1097/01.ju.0000147305.00443.df.

  PMID: 15592060 BACKGROUND

• Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. External intercostal muscles and external anal sphincter electromyographic activity during coughing. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Apr;19(4):521-4. doi: 10.1007/s00192-007-0473-y. Epub 2007 Oct 13.

  PMID: 17934686 BACKGROUND

• Fritel X, Fauconnier A, Bader G, Cosson M, Debodinance P, Deffieux X, Denys P, Dompeyre P, Faltin D, Fatton B, Haab F, Hermieux JF, Kerdraon J, Mares P, Mellier G, Michel-Laaengh N, Nadeau C, Robain G, de Tayrac R, Jacquetin B; French College of Gynaecologists and Obstetricians. Diagnosis and management of adult female stress urinary incontinence: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians. Eur J Obstet Gynecol Reprod Biol. 2010 Jul;151(1):14-9. doi: 10.1016/j.ejogrb.2010.02.041. Epub 2010 Mar 16.

  PMID: 20236751 BACKGROUND

• Hermieu JF, Denys P, Fritel X. [Critical review of guidelines for female urinary incontinence diagnosis and treatment]. Prog Urol. 2012 Oct;22(11):636-43. doi: 10.1016/j.purol.2012.08.004. Epub 2012 Sep 10. French.

  PMID: 22999088 BACKGROUND

• Klovning A, Avery K, Sandvik H, Hunskaar S. Comparison of two questionnaires for assessing the severity of urinary incontinence: The ICIQ-UI SF versus the incontinence severity index. Neurourol Urodyn. 2009;28(5):411-5. doi: 10.1002/nau.20674.

  PMID: 19214996 BACKGROUND

• Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.

  PMID: 10813117 BACKGROUND

• Horton AM Jr, Alana S. Validation of the Mini-Mental State Examination. Int J Neurosci. 1990 Aug;53(2-4):209-12. doi: 10.3109/00207459008986604.

  PMID: 2265941 BACKGROUND

• Thubert T, Villot A, Billecocq S, Auclair L, Amarenco G, Deffieux X. Influence of a distraction task on the involuntary reflex contraction of the pelvic floor muscles following cough. Neurourol Urodyn. 2017 Jan;36(1):160-165. doi: 10.1002/nau.22903. Epub 2015 Oct 9.

  PMID: 26451967 RESULT

• Thubert T, Deffieux X, Jousse M, Guinet-Lacoste A, Ismael SS, Amarenco G. Influence of a distraction task on pelvic floor muscle contraction. Neurourol Urodyn. 2015 Feb;34(2):139-43. doi: 10.1002/nau.22524. Epub 2014 Feb 12.

  PMID: 24519688 RESULT

• Villot A, Deffieux X, Billecocq S, Auclair L, Amarenco G, Thubert T. Influence of cognitive rehabilitation on pelvic floor muscle contraction: A randomized controlled trial. Neurourol Urodyn. 2017 Aug;36(6):1636-1644. doi: 10.1002/nau.23169. Epub 2016 Oct 29.

  PMID: 27794195 RESULT

• Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. Pelvic floor muscle activity during coughing: altered pattern in women with stress urinary incontinence. Urology. 2007 Sep;70(3):443-7; discussion 447-8. doi: 10.1016/j.urology.2007.03.084.

  PMID: 17905093 RESULT

• Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. Abnormal pelvic response to cough in women with stress urinary incontinence. Neurourol Urodyn. 2008;27(4):291-6. doi: 10.1002/nau.20506.

  PMID: 17803192 RESULT

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thibault THUBERT, MD

  CHU Hotel Dieu Nantes

  PRINCIPAL INVESTIGATOR

• Pierre-André MAL, resident

  CHU Hopital Tenon APHP

  STUDY CHAIR

Central Study Contacts

Thibault THUBERT, MD

CONTACT

+33647697800; Thibault.thubert@chu-nantes.fr

Pierre-André MAL, resident

CONTACT

+33659363500; malpierreandre@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor of Gynecology

Model Details: This study is a controlled randomized single blind multicentric study on a sample of 40 women stress or mixed urinary incontinent. Participants will be randomized in two groups with a 1/1 ratio with data processing software at the first visit at the therapist practicing the perineal rehabilitation. The first group will receive "Classical" perineal rehabilitation for duration of height weeks. The second group will receive perineal rehabilitation associated to a double task cognitive therapy for duration of height weeks. Participants will be evaluated during the consultation.

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 9, 2019
• Study Start: January 10, 2019
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: January 10, 2019

Record last verified: 2019-01