NCT07105150

Brief Summary

The aim of this clinical trial is to assess the effectiveness of a 4-week video-based education program in enhancing urinary continence among women with urinary incontinence referred for pelvic floor rehabilitation The main question it aims to answer is :

  • Does a structured video-based education program reduce the symptoms of urinary incontinence before any pelvic floor muscle strengthening ? Researchers will compare this program to a paper document (providing similar information) to see if this improves urinary continence in women suffering from urinary incontinence. Participants will :
  • receive either the video-based education program or a paper information document (providing similar information) prior to the sessions with the physiotherapist
  • then follow pelvic floor rehabilitation sessions with the physiotherapist according to usual practice
  • complete the urinary incontinence questionnaire after the 4-week video education program (intervention group) or 4 weeks after receiving the paper document (control group), and after each pelvic floor rehabilitation session with the physiotherapist and at the end of the sessions
  • will be monitored at 1 and 2 years to evaluate urinary incontinence following the intervention.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
45mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jan 2026Jan 2030

First Submitted

Initial submission to the registry

July 12, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

January 9, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2028

Expected
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2030

Last Updated

February 10, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

July 12, 2025

Last Update Submit

February 9, 2026

Conditions

Keywords

urinary incontinencepelvic floor rehabilitationvideo-based programeducation

Outcome Measures

Primary Outcomes (1)

  • Urinary incontinence score comparison between the 2 groups

    the urinary incontinence score will measured using the ICIQ-SF (International Consultation on Incontinence Questionnaire-Short Form), ranging from 0 (corresponding to 'no urinary incontinence') to 21 (corresponding to 'very severe urinary incontinence'), collected after the video-based education program in the intervention group (scheduled over 4 weeks) and within the same timeframe in the control group (which received only the information document)

    At the end of the video-based education program (5 weeks after inclusion)

Secondary Outcomes (25)

  • Urinary incontinence score evolution in the intervention group

    from inclusion until the end of the video education program (5 weeks after inclusion)

  • Urinary incontinence score evolution in the control group

    from inclusion to 5 weeks following the distribution of the paper information document

  • Number of pelvic floor rehabilitation sessions required in the intervention group

    ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months

  • Number of pelvic floor rehabilitation sessions required in the control group

    ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months

  • Urinary incontinence score evolution during the pelvic floor rehabilitation sessions in the intervention group

    ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months

  • +20 more secondary outcomes

Study Arms (2)

video-based education program group

EXPERIMENTAL
Behavioral: video-based education program

written information group

ACTIVE COMPARATOR
Other: written information

Interventions

The video-based education program will include 4 workshops of 20 minutes each, at a rate of 1 video per week: Video 1: Anatomy and physiology of the pelvic floor; Video 2: Physiology of the urinary tract; Video 3: Physiology of the digestive tract; Video 4: Pathophysiology of urinary incontinence and other pelvic floor disorders (genital prolapse and anal incontinence) and preventive measures in daily activities.

video-based education program group

The control group will receive a paper information document (containing the same information as the intervention group) during the 4-week period

written information group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any woman referred for pelvic floor rehabilitation sessions for urinary incontinence (defined as 'any involuntary leakage reported by the patient' according to the International Continence Society)
  • Women requiring perineal rehabilitation for urinary incontinence
  • Aged 18 years or older
  • Having access to a connected device (tablet, smartphone, computer)
  • Having a functional email address
  • Covered by a social security scheme
  • Informed, and written consent (signed by the participant and the investigator)

You may not qualify if:

  • Women unable to complete questionnaires (unable to read French or unable to write)
  • Visually impaired individuals who cannot watch the video or read the printed material
  • Genital prolapse extending beyond the hymen
  • Documented neurological disorders
  • Individuals receiving psychiatric care and those unable to express their consent
  • History of pelvic fractures or dorsolumbar surgery
  • Chronic pelvic pain
  • Women who have given birth within the last 6 month
  • Individuals with enhanced protection: minors, individuals deprived of liberty, individuals residing in a health or social institution, pregnant or breastfeeding women, adults under legal protection, and patients in emergency situations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Mme ROSSIGNOL Marie - Kinésithérapeute - 5 place du Lavoir

Buxy, 71390, France

NOT YET RECRUITING

Mme BLANCHARD Véronique - Kinésithérapeute

Chanceaux-sur-Choisille, 37390, France

RECRUITING

Mme GIRARD Delphine - kinésithérapeute - 14 rue de la Liberté

Embrun, 05200, France

NOT YET RECRUITING

Mme LIAGRE Blandine - Kinésithérapeute - 120 rue de Chanzy

Hellemmes-Lille, 59260, France

RECRUITING

Mme BESSON Alice - Kinésithérapeute - 22 rue Benjamin Franklin

La Roche-sur-Yon, 85000, France

NOT YET RECRUITING

Mme OLIVIER Mathilde - Groupe médical du Barry - 34 Bis Rue du Quatre Septembre

Montignac, 24290, France

NOT YET RECRUITING

Mme CALONNE Hélène - Kinésithérapeute - 23 rue Franiatte

Montigny-lès-Metz, 57950, France

NOT YET RECRUITING

Mme LE TILLY Marine - Kinésithérapeute - 181 rue Legendre

Paris, 75017, France

NOT YET RECRUITING

Mme GIEN Isabelle - Kinésithérapeute - 2 Rue Adrienne Bolland

Saint-Jean-de-Braye, 45800, France

NOT YET RECRUITING

Mme LACOMBE Florence - Kinésithérapeute - 2 Rue Gabriel Durand

Saint-Médard-en-Jalles, 33160, France

RECRUITING

Mme RIERE Claire - Kinésithérapeute - 62 Route de Saint-Aubin

Saint-Médard-en-Jalles, 53218, France

RECRUITING

Mme GRUYER DROUET Laurence - Kinésithérapeute - 7 Rue Jean Baptiste Clément

Villejuif, 94800, France

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anne Cecile Pizzoferrato, M.D

    University Hospital Center of Poitiers

    STUDY DIRECTOR

Central Study Contacts

Veronique Blanchard

CONTACT

Anne Cecile Pizzoferrato, M.D

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 12, 2025

First Posted

August 5, 2025

Study Start

January 9, 2026

Primary Completion (Estimated)

February 15, 2028

Study Completion (Estimated)

January 9, 2030

Last Updated

February 10, 2026

Record last verified: 2026-01

Locations