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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorVilnius University

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years or older

This pregnancy was singleton

No contraindications for physical activity

No connective tissue disorders (for example Ehlers-Danlos syndrome)

Disqualifiers

Younger than 18 years

Twins or triplet pregnancy

Contraindications for physical activity

Connective tissue disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rehabilitation postpartum

    Behavioral

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

  • Self-training

    Behavioral

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Group of participants getting specialist supervised training postpartumActive comparator 1 intervention
Group B: Group of participants doing self-training with an appOther 1 intervention

Trial outcomes

Primary outcomes

1

Improvement in pelvic floor dysfunction symptoms

Self-reported improvement of symptoms (for example: pain, urinary incontinence, fecal incontinence, vaginal "laxity")

Time frame
Asked at the beginning (first postpartum visit, 6-8 weeks postpartum), after first set of training (6months), after second set of training (12 months)
2

Change in PFM contraction force and strength according to the Modified Oxford Scale

Individual change in Oxford scores (0-5), bigger number means stronger contraction.

Time frame
Measured before training, immediately after first set of training, 6 months from the beginning, before starting second set of training and immediately after second set of training, about 12 months from the beginning
3

Change in POP-Q scale

changes in POP-Q scales (especially in gh - genital hiatus, pb - perineal body, measured by centimeters, bigger number in gh means wider genital hiatus -worse outcome; smaller number in pb means thin perineal body - worse outcome)

Time frame
Measured before starting the program, after first set of training (6 months from beginning) and after second set of training (12 months from beginning)
4

Change in life quality questionnaires ICIQ-UI SF

Quality of Life (QoL) and clinical outcome questionnaires: \* ICIQ-UI SF (International Consultation on Incontinence Questionnaire Short Form); scores 1-21, higher the number - worse outcome

Time frame
Questionnaires will be given at the beginning (excluding sexual function related questionnaires, due to short time after delivery), after first set of training (6 months from the beginning), after second set of training (12 months from the beginning).

Secondary outcomes

1

Factors potentially influencing the effectiveness of the rehabilitation program: mean age

Age in years Advanced age is a risk factor for PFD

Time frame
Asked and documented at first postpartum visit, 6-8 weeks postpartum
2

Other participant and birth related factors which may have influence on pelvic floor: BMI

BMI (kg/m\^2) Higher BMI is a risk factor for PFD

Time frame
Asked and documented at first postpartum visit, 6-8 weeks postpartum
3

Other participant and birth related factors which may have influence on pelvic floor: number of births

Number of births (after 22 gestational weeks) Higher number of births is a risk factor for PFD

Time frame
Asked and documented at first postpartum visit, 6-8 weeks postpartum
4

Other participant and birth related factors which may have influence on pelvic floor: mode of delivery

Mode of delivery: natural, vacuum, forceps, c - section Vacuum or forceps assisted delivery is related to higher PFD rates compared to c - section or natural

Time frame
Asked and documented at first postpartum visit, 6-8 weeks postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vilnius University

Lead sponsor

Vilnius University Hospital Santaros Klinikos

Collaborator

Vilnius Maternity Hospital

Collaborator