Pelvic Floor Muscle Training During Pregnancy

NCT07104292 | Recruiting

• 1 other identifier: SHS-KS-06-2025
• Study Type: interventional
• Target: 734
• Locations: 1 country
• Sites: 1

Brief Summary

The project seeks to investigate effectiveness of PFMT during pregnancy.

Conditions

Pelvic Floor; Urinary Incontinence; Anal Incontinence; Pelvic Organ Prolapse; Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• Urinary incontinence (UI) incidence at 3 months postpartum

  International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score between 0 (perfect continence) and 21 (total incontinence).

  At 3 months follow-up after giving birth

Secondary Outcomes (31)

• Urinary incontinence at the 1st trimester of pregnancy

  At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days)

• Urinary incontinence at the 2nd trimester of pregnancy

  At the follow-up at Gestational age 26 weeks and 0 days

• Urinary incontinence incidence at the 3rd trimester of pregnancy

  At the follow-up at Gestational Age 36 weeks and 0 days

• Urinary incontinence incidence at 6 weeks postpartum

  At the follow-up at 6 weeks postpartum

• Anal incontinence (AI) incidence at inclusion, during the 1st trimester of pregnancy

  At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days)

Study Arms (2)

Pelvic Floor Muscle Training (PFMT)

EXPERIMENTAL

A Danish professional pelvic floor physiotherapist together with a midwife and an urogynecologist have created a free of charge training program, which is easily accessible via a danish website "www.kvindekrop.dk" or via the app "Pelvic FloorTrainer". The women will receive an easily accessible, home-based PFMT program electronically in which they will be motivated to start and engage during pregnancy with continuity after birth.

Behavioral: PFMT

Standard care

PLACEBO COMPARATOR

The control group will receive routine care - recommendation to do the training without any further instructions.

Behavioral: Standard care

Interventions

PFMT BEHAVIORAL

The motivation-informed intervention will tackle both exercise engagement and exercise adherence. Participating women will be introduced to the app and its videos following training. The participants will be introduced not only to muscle training, but also to muscle relaxation. The training will be recommended three to four times a week during pregnancy with further continuity after giving birth.

Pelvic Floor Muscle Training (PFMT)

Standard care BEHAVIORAL

Standard care

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman in the 1st trimester of pregnancy (up to 12+6 weeks of gestation)
• Para 0 (no previous birth or pregnancy \> 16 weeks of gestation)
• Understands, writes, and reads fluently in Danish or English
• Has a smart phone or computer/tablet to reach the training program

You may not qualify if:

• Severe psychiatric illness (e.g. schizophrenia, bipolar disorder, severe depression or anxiety)
• Active substance abuse
• Acute social crises (e.g. homelessness, ongoing domestic violence, severe financial instability, lack of social support)
• Women with limited capacity to provide informed consent (due to cognitive impairment or language barriers)
• Previous pregnancy of \> 16 weeks of gestation

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Sygehus Sønderjylland

Aabenraa, Southern Denmark, 6200, Denmark

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence; Encopresis; Pelvic Organ Prolapse; Sexual Dysfunction, Physiological

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Prolapse; Pathological Conditions, Anatomical; Genital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jan Stener Jørgensen

  University Hospital of Southern Denmark

  STUDY CHAIR

Central Study Contacts

Greta Puriene

CONTACT

+4571638335; greta.puriene@rsyd.dk

Christina Prinds

CONTACT

+4565504953; cprinds@health.sdu.dk

Study Design

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

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: August 5, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)