Adapted Physical Activity Based On Trunk Stabilization And Pelvic Floor Education For Female Pelvic Floor Disorders

NCT07789977 | Not Yet Recruiting

• 3 other identifiers: Unistra/CER/2025-9120240741725E0015642825-DOC-031
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Disorder

Keywords

exercise intervention; care seeking; behaviour change; women's health

Outcome Measures

Primary Outcomes (1)

• Self-reported pelvic floor symptoms: Pelvic Floor Distress Inventory short-form questionnaire (PFDI-20)

  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).

  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)

Secondary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (8)

• Motivation for physical activity in a health context

  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)

• Motivational and volitional stage assessment (care-seeking and physical activity 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)

• Outcome expectancies (care-seeking and physical activity 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)

Study Arms (2)

Intervention APA + education

EXPERIMENTAL

This group will participate in a program combining a weekly session of adapted physical activity focused on trunk stabilization and a monthly session on pelvic floor education, over a three-month period.

Behavioral: Adapted Physical Activity and education

Waiting list

NO INTERVENTION

The waiting list will not receive the intervention for 3 months.

Interventions

Adapted Physical Activity and education BEHAVIORAL

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

Also known as: Adapted Physical Activity, Pelvic floor education

Intervention APA + education

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Strasbourg: lead

Study Sites (1)

Université de Strasbourg

Mulhouse, Alsace, 68 100, France

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Maria Popa-Roch

  Université de Strasbourg

  STUDY DIRECTOR

• Géraldine Escriva-Boulley

  University of Nimes

  STUDY DIRECTOR

Central Study Contacts

Marie-Anne Jean

CONTACT

+33 6 43 03 62 44; ma.jean@unistra.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The control group is a waiting list that will receive the intervention at the end of the program.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)