Best Verbal Instruction to Obtain Voluntary Pelvic Floor Muscle Contraction

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

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.

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• France
  • Paris, France, 75020
    • department of Neuro-Urology, Hôpital Tenon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients consulting in a tertiary center in neuro-urology.

Description

Inclusion Criteria:

• Follow in neuro-urology
• Lower urinary tract symptoms

Exclusion Criteria:

• Can't speak French

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the instructions used by the professionals	Qualitative description of the instructions and selection of the most frequent instructions.	1 day during the consultation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability, understanding and selection of the best instruction by the subjects	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).	1 day during the consultation

Collaborators and Investigators

• Sponsor: Pierre and Marie Curie University
• Investigators: Principal Investigator: Gérard Amarenco, PhD, UPMC, Sorbonne Université, Univ Paris 6, service neuro-urologie, hôpital TENON, Paris

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2017
• Primary Completion (Actual): September 18, 2017
• Study Completion (Actual): September 29, 2017

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 5, 2017

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: assessment; acceptability; pelvic floor muscles; understanding; instruction
• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: P. GREEN 01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No