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Trial record 15 of 271 for:    Recruiting, Not yet recruiting, Available Studies | "Lower Urinary Tract Symptoms"

Best Verbal Instruction to Obtain Voluntary Pelvic Floor Muscle Contraction

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ClinicalTrials.gov Identifier: NCT03272386
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Gérard Amarenco, Pierre and Marie Curie University

Brief Summary:
The purpose of this study is to determine the best verbal instruction to obtain a PFMC and to evaluate the understanding and acceptability of the proposed instructions.

Condition or disease Intervention/treatment
Lower Urinary Tract Symptoms Other: Observational study

Detailed Description:

Pelvic floor muscles contraction (PFMC) is usually recommended for evaluation and treatment of pelvic floor disorders.

In clinical practice, many patients fail to achieve a voluntary PFMC and only about one-third of women perform an ideal PFMC after brief written or verbal instruction. When no PFMC is elicited, it might be explained by an anatomical or neurological issue but also by a lack of understanding of the instructions and / or poor knowledge of the anatomy. Pelvic floor muscles (PFM) evaluation may depends on the method used to elicit and assess the contraction including verbal instructions. There is no current gold standard methodology for quantifying PFM strength and the verbal instructions used to elicit the PFMC are rarely reported in the studies. There is few specific works about the instructions. One recent study report that the pattern of urethral movement is influenced by the instructions used to teach activation of the PFM in men. Another study showed that some specific instructions are most effective in eliciting a correct PFMC in women.

Thus, an appropriate verbal instruction in terms of understanding, social and cultural acceptability, taking into account the anatomical knowledge of the patients, would probably allow a better evaluation of the PFM and even a better efficacy of pelvic floor training.

The purpose of this study is to determine the best verbal instruction to obtain a PFMC and to evaluate the understanding and acceptability of the proposed instructions.

This is a prospective observational study lead in two phases in the Neurourology Department of a University Hospital.

Phase 1: survey carry out the health professionals. Members of the scientific committees of national academic societies in neuro-urology, pelvi-perineology and pelvic-floor neurophysiology would be invited to answer a questionnaire by mail. It will include open questions about the most frequently verbal instructions used to elicit a PFMC. These instructions will be collected, analysed and selected for the second phase.

Phase 2: structured interviews with patients and with non-health professional subjects.

Patients and non-health professionals subjects will be invited to answer a 3-parts questionnaire based on the gender: (i) demographic, social and medical data; (ii) evaluation of the anatomical knowledge of the perineum with a picture of the perineum and a sagittal section of the pelvic area of the corresponding sex. In the third part (iii), the participants will assess the instructions selected in the first phase according to their understanding and their acceptability (good, intermediate, poor). They finally will have to choose the best instruction i.e. which seems to be the more suitable to obtain a PFMC.

Ethics: a local ethics committee approved this study. Since it is an observational study, the participant will have a newsletter.


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Study Type : Observational
Estimated Enrollment : 33 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Verbal Instruction to Obtain Voluntary Pelvic Floor Muscle Contraction: Acceptability, Understanding and Best Instruction
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : September 18, 2017
Estimated Study Completion Date : September 29, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Observational study
Observational study with patients over 18 years old, consulting for lower urinary tract symptoms in a tertiary center are included.
Other: Observational study
Completing a questionnaire




Primary Outcome Measures :
  1. Description of the instructions used by the professionals [ Time Frame: 1 day during the consultation ]
    Qualitative description of the instructions and selection of the most frequent instructions.


Secondary Outcome Measures :
  1. Acceptability, understanding and selection of the best instruction by the subjects [ Time Frame: 1 day during the consultation ]
    Description of the selected instructions by the subjects : their acceptability (poor / moderate / good), and understanding (poor / moderate / good) and the best instruction to obtain PFMC (among the selected instructions).



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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 consulting in a tertiary center in neuro-urology.
Criteria

Inclusion Criteria:

  • Follow in neuro-urology
  • Lower urinary tract symptoms

Exclusion Criteria:

  • Can't speak French

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): NCT03272386


Contacts
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Contact: Audrey Charlanes, MD +33156017500 greengrc01@gmail.com
Contact: Gérard Amarenco, PhD +33156017500 greengrc01@gmail.com

Locations
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France
Department of neuro-urology, hôpital Tenon Recruiting
Paris, France, 75020
Contact: Audrey Charlanes, MD    +33156017040    greengrc01@gmail.com   
Contact: Gérard Amarenco, PhD    +33156017040    greengrc01@gmail.com   
Principal Investigator: Gérard Amarenco, PhD         
Sub-Investigator: Audrey Charlanes, MD         
Sponsors and Collaborators
Pierre and Marie Curie University
Investigators
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Principal Investigator: Gérard Amarenco, PhD UPMC, Sorbonne Université, Univ Paris 6, service neuro-urologie, hôpital TENON, Paris

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Responsible Party: Gérard Amarenco, Head of Neuro-Urology department, Tenon hospital, Pierre and Marie Curie University
ClinicalTrials.gov Identifier: NCT03272386     History of Changes
Other Study ID Numbers: P. GREEN 01
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gérard Amarenco, Pierre and Marie Curie University:
pelvic floor muscles
instruction
assessment
acceptability
understanding

Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms