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Completed

NCT Number: NCT03272386

Best Verbal Instruction to Obtain Voluntary Pelvic Floor Muscle Contraction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of neuro-urology, hôpital Tenon

Paris, 75020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Follow in neuro-urology
  • Lower urinary tract symptoms

Exclusion criteria

  • Can't speak French

Treatment and study plan

observational study

Other

Completing a questionnaire

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Pierre and Marie Curie University

Other

Registry information

Official study title

Verbal Instruction to Obtain Voluntary Pelvic Floor Muscle Contraction: Acceptability, Understanding and Best Instruction

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 5, 2017
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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