Comparison of Outpatient Rehabilitation Versus Self-training for the Treatment and Prevention of Postpartum Pelvic Floor Dysfunction

Summary

The main goal of this study to compare self-training postpartum and training with a specialist support (physiotherapist and physical medicine and rehabilitation doctor) effect on pelvic floor dysfunction prevention and treatment in postpartum period.

Hypothesis: The implementation of postpartum rehabilitation helps to alleviate existing symptoms of pelvic floor dysfunction and prevents pelvic floor dysfunction.

Study goals:

* To objectively evaluate changes in pelvic organ position and pelvic floor muscle function in postpartum period, before and after specialised rehabilitation program
* To objectively evaluate pelvic floor symptoms and their influence on woman life quality
* To compare data (changes in pelvic floor muscle coordination and strength, pelvic organ position and changes in life quality according to validated questionnaires)

Study participants will:

* Get an examination by obstetrician-gynaecologist, physical medicine and rehabilitation doctor and physiotherapist in 6 to 10 weeks postpartum period.
* One group of participants will attend physiotherapy, biofeedback and electro stimulation procedures with a guidance of a specialist.
* Other group of participants gets a recommendations and instructions of training and self-trains at home. To remind of training and help record training time "squeezy" app (an application designed for a mobile device) will be offered.
* All groups of participants will be asked to fill life quality related questionnaires: (ICIQ-UI SF: International Consultation on Incontinence Questionnaire; P-QoL: Prolapse Quality-of-Life Questionnaire; PISQ-IR: Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire IUGA revised; FSFI: female sexual function index; MOS-SF36 Medical Outcomes Study Short Form-36).

Conditions

• Pelvic Floor Dysfunction
• Postpartum Care
• Postpartum Comfort
• Female Urinary Incontinence and Pelvic Organ Prolapse
• Rectus Diastasis
• Sexual Dysfunction Female

Interventions

BEHAVIORAL

Rehabilitation postpartum

* 4 Times biofeedback training * 10 times physiotherapy with specialist * 10 times transcutaneal electrostimulation (TENS)

BEHAVIORAL

Self-training

* training at home after physiotherapist instructions * using an app to record training frequency, length

Sponsors & Collaborators

• Vilnius University Hospital Santaros Klinikos

  collaborator OTHER

• Vilnius Maternity Hospital

  collaborator UNKNOWN

• Vilnius University

  lead OTHER

Principal Investigators

• Lina Būtėnaitė, MD, PhD · Vilnius University

• Daiva Bartkevičienė, Assoc. prof. · Vilnius University

• Eglė Pilkionytė, MD · Vilnius University

• Ivona Ivanovska, MD · Vilnius University

• Rūta Petravičienė · Vilnius University

• Karolina Eva Romeikienė, MD, PhD student · Vilnius University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-30

Primary Completion

2027-09-30

Completion

2029-09-30

Countries

• Lithuania

Study Locations