Pelvic Floor Disorder
Conditions
Keywords
exercise intervention, care seeking, behaviour change, women's health
Brief summary
Pelvic floor disorders affect a substantial proportion of women worldwide and represent a significant public health concern due to their impact on physical function, quality of life, and psychosocial well-being. Growing interest has emerged in physical activity programs for pelvic floor disorders as a noninvasive and accessible intervention strategy. This study aims to evaluate the effect of an intervention combining a weekly Adapted Physical Activity (APA) session focused on trunk stabilization and a monthly pelvic floor education session over a three-month period to improve self-reported pelvic floor symptoms. The secondary objectives are to investigate the effects of this intervention on quality of life, pelvic floor knowledge, stigma, care-seeking behavior, and physical activity behavior. Participants will be randomly assigned to one of two groups for 3 months: (1) intervention APA + education or (2) waitlist. Participants in the waitlist group will receive the intervention three months after the program's launch. This study could help provide additional data to improve education of the pelvic floor and care seeking, as well as to better understand the effect of physical activity for pelvic floor disorders.
Detailed description
This study will include women who reported having a pelvic floor disorder. The study will be a randomized controlled trial with three measurement time points, before and after the intervention (immediate post-test and delayed post-test at 3 months), and two groups. One group will receive Adapted Physical Activity (APA) + education intervention, and the control group will be placed on a waiting list for 3 months. Participants in the control group may then follow the program if they wish. We hypothesize that APA program based on trunk stabilization combined with an educational intervention improves self-reported symptoms of pelvic floor disorders, knowledge, and care-seeking behavior (including physical activity) compared to a group that receives no intervention. We expect these effects to appear immediately after the intervention (immediate post-test) and to persist over time (delayed post-test at 3 months). APA refers both to tailored exercise or sports interventions designed to promote health among people with chronic diseases, health conditions, or disabilities and to a scientific discipline that designs and studies interventions for health and educational purposes. APA provides a framework for implementing the principles of trunk stabilization in the context of pelvic floor disorders, notably through learning diaphragmatic breathing and the co-activation of the pelvic floor and the transversus abdominis, specific training to strengthen the core muscles, and incorporating dynamic exercises with light to moderate impact (jumps, side steps, etc.). Adapted physical activity sessions based on the trunk stabilization principle will last 60 minutes and will include 15-minute warm-up (body and joint mobilizations from head to toe, and breathing exercise) followed by 30-minute main continuous session (trunk stabilization and strengthening exercises), and 15-minute cooldown for stretching and mobility exercises. The programme will be organized in three phases, to be implemented progressively: (1) learning the diaphragmatic breathing pattern, the co-activation of the pelvic floor and the transversus abdominis muscles in standing, sitting, and lying positions; (2) specifically working the engagement of the transversus abdominis muscles in static, dynamic, and balance exercises while strengthening the core muscles; (3) integrating dynamic exercises with light to moderate impact (jumping, side steps, etc.). Exercise instructions will include posture, pelvic floor engagement, and respiratory instructions on effort. The educational sessions will last between 60 to 90 minutes. The first session will focus on the prevalence and common beliefs surrounding the pelvic floor, providing a brief introduction to common risk factors. The functioning (anatomy, function, and biomechanics) of the pelvic floor will then be presented using educational anatomical videos. In the second session, lifestyle-related risk factors and preventive measures will be discussed through a group workshop (e.g. urinary and defecatory physiologies, the impact of sport, posture, overweight and obesity, and hygiene and dietary recommendations for constipation). Participants will be invited to consider how to plan their physical activity in anticipation of the end of the program and any obstacles they may need to overcome. The final session will cover the care pathways available for pelvic floor disorders; participants will then be invited to consider how to plan for a potential future appointment with a healthcare professional and any barriers they may need to overcome.
Interventions
BEHAVIORALAdapted Physical Activity and education
Intervention combining a weekly session of adapted physical activity focused on trunk stabilization and a monthly pelvic floor education session, over a three-month period
Sponsors
Université de Strasbourg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The control group is a waiting list that will receive the intervention at the end of the program.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women over 18 years old * At least one symptom associated with a pelvic floor disorder (urinary or faecal incontinence, a feeling of heaviness or bulging in the genital area, difficulty passing stools) which causes bother (ranging from mild to severe) * Not already undergoing pelvic floor rehabilitation with a professional (physiotherapist or midwife) * No major mobility limitations such as being unable to get up from a supine to standing position unassisted * Proficient in reading, writing and speaking French * Not pregnant * BMI below 40 * Regardless of hormonal status (natural cycle, contraceptive pill, menopause)
Exclusion criteria
* Scheduled surgery during the study * Postpartum (less than 3 months) * Pelvic surgery in the past 3 months * Current urinary tract infection or haematuria * Current pelvic cancer or radiation, Interstitial cystitis * Congenital defect leading to pelvic floor disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported pelvic floor symptoms: Pelvic Floor Distress Inventory short-form questionnaire (PFDI-20) | Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention) | The PFDI-20 has a total of 20 questions and 3 scales: Urinary Distress Inventory (UDI-6, questions 1 to 6), Pelvic Organ Prolapse Distress Inventory (POPDI-6, questions 7 to 14), and the Colorectal-Anal Distress Inventory (CRADI-8, questions 15 to 20). Each of the 3 scales of the PFDI-20 has a score range from 0 (least distress) to 100 (greatest distress) and is calculated based on the mean score of the questions (values ranging from 0 to 4), multiplied by 25. The total PFDI-20 score is obtained by summing the scores for each scale (ranging from 0 to 300). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Floor impact on Quality-of-life short form questionnaire (PFIQ-7) | Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention) | This questionnaire consists of a table with 7 questions in lines and each of 3 scales in columns for the Urinary Impact Questionnaire (UIQ), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ), and the Colorectal-Anal Impact Questionnaire (CRAIQ). Each of the 3 scales is scored from 0 (no impact) to 100 (greatest adverse impact) and is calculated based on the mean score of the questions (a value between 0 and 3) and then multiplied by 100/3 to derive the scale score (ranging from 0 to 100). The total PFIQ-7 score is obtained by summing the scores for each scale (ranging from 0 to 300). |
| Knoledge of the pelvic floor: Antwerp Pelvic Floor Knowledge Questionnaire (APFK-Q) | Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention) | Knowledge of the pelvic floor will be assessed with the APFK-Q. This questionnaire contains 33 items, and 31 items assess women's knowledge of the structure and function of the pelvic floor, urinary and defecatory physiology, the main pelvic floor disorders, risk factors, and management of pelvic floor disorders. Two items were dedicated to the perception of the level of self-knowledge of the participant concerning the pelvic floor (item 1) and care pathway (item 33). No scoring method is provided for this questionnaire; therefore, a percentage of total correct answers can be calculated across the knowledge assessment items. |
| Stigma related to pelvic floor disorders: Stigma Scale for Chronic Illnesses 8-Item Version (SSCI-8) | Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention) | Enacted and internalized stigma related to pelvic floor disorders will be assessed with the SSCI-8 adapted for pelvic floor disorders. Each of the 8 items is rated from 1 (Never) to 5 (Always). The total score ranges from 8 to 40, calculated by summing all the items. This tool has already been used in a population with pelvic floor disorders. |
| Social support: Sarason's Social Support Questionnaire (SSQ6) | Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention) | This questionnaire is a 12-item measure comprising two questions per item that assess perceived social support availability and satisfaction. For each of the six situations, respondents indicate the people they could count on (up to a maximum of nine people) and rate their satisfaction with the available support on a 6-point scale, from 1 (very dissatisfied) to 6 (very satisfied). Two separate total scores are calculated: an availability score (N), corresponding to the total number of people listed across the six situations and ranging from 0 to 54, and a satisfaction score and a satisfaction score (S), obtained by summing the six satisfaction ratings and ranging from 6 to 36. Higher N scores indicate greater perceived availability of social support, while higher S scores indicate greater satisfaction with the available support. |
| Physical activity behavior: International Physical Activity Questionnaire short-form (IPAQ) | Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention) | For each type of physical activity, the MET-minutes per week are calculated by multiplying the number of minutes spent on the activity per day by the number of days per week on which the activity is performed and by the corresponding MET value. An average MET score has been established for each type of activity. Total physical activity is then calculated by summing the MET-minutes per week for walking, moderate-intensity physical activity, and vigorous-intensity physical activity. |
| Care-seeking behavior | Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention) | Care seeking is assessed using three questions. (1) related to consultation, (2) related to initiation of pelvic floor rehabilitation with a professional (physiotherapist or midwife), and (3) related to discontinuation of the planned pelvic floor rehabilitation. The results will be presented in four categories: (1) did not seek care, (2) consulted a healthcare professional, (3) began supervised pelvic floor rehabilitation (physiotherapist or midwife), and (4) discontinued pelvic floor rehabilitation prematurely. The outcome analyzed will be a binary measure of engagement in the process of care seeking. Individuals who sought care will be counted in care-seeking behavior and compared with those who did not initiate the process. |
Countries
France
Contacts
CONTACTMarie-Anne Jean
STUDY_DIRECTORMaria Popa-Roch
Université de Strasbourg
STUDY_DIRECTORGéraldine Escriva-Boulley
University of Nimes
Outcome results
None listed