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

NCT07426770 | Recruiting DMC

• 3 other identifiers: 2023/6-1527-986Vilnius UniversityVilnius University Hospital
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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; Rectus Diastasis; Sexual Dysfunction Female; Female Urinary Incontinence and Pelvic Organ Prolapse

Keywords

Pelvic floor dysfunction postpartum; Postpartum urinary incontinence; Postpartum sexual dysfunction; Diastasis postpartum; Rehabilitation postpartum

Outcome Measures

Primary Outcomes (10)

• Improvement in pelvic floor dysfunction symptoms

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

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

• 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.

  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

• 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)

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

• 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

  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).

• Better voluntary pelvic floor muscle control

  observation (compensatory muscles: abdominal, thighs, glutes movements during the contraction)

  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

• Objectively measured change in pelvic floor muscle strength

  Contraction measured with Myomed biofeedback device (manometry kPha)

  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

• Quality of Life (QoL) and clinical outcome questionnaires: P-QoL

  P-QoL (Prolapse Quality-of-Life Questionnaire) measures the impact of pelvic organ prolapse (POP) on a patient's life across eight domains, with total scores ranging from 0 (best) to 100 (worst). High scores indicate poor quality of life, while lower scores (often \<40 or \<20) indicate higher QOL and improvement after intervention

  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).

• Quality of Life (QoL) and clinical outcome questionnaires: PISQ-IR

  PISQ-IR (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised) evaluates female sexual function (FSF) in women with pelvic floor disorders (PFD), using a 2.68 summary score cutoff for sexually active (SA) women to identify sexual dysfunction (values \>2.68 indicate no dysfunction). The survey separates patients into SA and not sexually active (NSA) groups. SA Scale: Higher scores indicate better sexual function. A mean score \\(\>2.68\\) suggests no dysfunction, with \\(90\\%\\) sensitivity and \\(73\\%\\) specificity.NSA Scale: Higher scores indicate a greater negative impact of pelvic floor disorders on sexual inactivity.

  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)

• Quality of Life (QoL) and clinical outcome questionnaires: FSFI (Female Sexual Function Index)

  FSFI (Female Sexual Function Index) is a 19-item validated questionnaire assessing female sexual function over the past month, with total scores ranging from 2.0 to 36.0. A total score of ≤26.55 is the standard cutoff indicating a potential risk for Female Sexual Dysfunction (FSD). Higher scores indicate better, more robust sexual functioning

  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)

• Quality of Life (QoL) and clinical outcome questionnaires: MOS-SF36

  MOS-SF36 (Medical Outcomes Study Short Form-36). s a 36-item, patient-reported survey measuring health-related quality of life across eight dimensions. Scores range from 0 to 100 for each subscale, with higher scores indicating better health functioning or fewer limitations. The survey evaluates physical, mental, and social health domains

  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 (4)

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

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

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

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

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

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

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

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

Study Arms (2)

Group of participants getting specialist supervised training postpartum

ACTIVE COMPARATOR

Woman 6-10 weeks postpartum starts training program with physiotherapist and physical medicine and rehabilitation physician supervision.

Behavioral: Rehabilitation postpartum

Group of participants doing self-training with an app

OTHER

Woman 6-10 weeks postpartum starts self- training program at home. At the beginning they are instructed by physiotherapist and physical medicine and rehabilitation physician. This group use an app "squeezy" to remind the to do training and record training time.

Behavioral: Self-training

Interventions

Rehabilitation postpartum BEHAVIORAL

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

Also known as: Physiotherapy, Biofeedback training, electrostimulation

Group of participants getting specialist supervised training postpartum

Self-training BEHAVIORAL

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

Also known as: pelvic floor dysfunction app

Group of participants doing self-training with an app

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female who had given birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years or older
• This pregnancy was singleton
• No contraindications for physical activity
• No connective tissue disorders (for example Ehlers-Danlos syndrome)
• No neurological disorders to influence pelvic floor symptoms (for example clinically significant spinal disc herniation)

You may not qualify if:

• Younger than 18 years
• Twins or triplet pregnancy
• Contraindications for physical activity
• Connective tissue disorders
• Neurological disorders

Sponsors & Collaborators

• Vilnius University: lead
• Vilnius University Hospital Santaros Klinikos: collaborator
• Vilnius Maternity Hospital: collaborator

Study Sites (1)

Vilnius University: study centers: "Vilnius University Hospital " Santaros Clinic", "Vilniaus Gimdymo Namai"

Vilnius, Lithuania

RECRUITING

Related Publications (4)

• Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women Stephanie J WoodleyPeter LawrensonRhianon BoyleJune D CodySiv MørkvedAshleigh KernohanE Jean C Hay-Smith Version published: 07 May 2020

  BACKGROUND

• Sigurdardottir T, Steingrimsdottir T, Geirsson RT, Halldorsson TI, Aspelund T, Bo K. Postpartum pelvic organ prolapse and pelvic floor muscle training: secondary analysis of a randomized controlled trial of primiparous women. Int Urogynecol J. 2023 Jun;34(6):1319-1326. doi: 10.1007/s00192-023-05502-8. Epub 2023 Mar 30.

  PMID: 36995416 BACKGROUND

• Beamish NF, Davenport MH, Ali MU, Gervais MJ, Sjwed TN, Bains G, Sivak A, Deering RE, Ruchat SM. Impact of postpartum exercise on pelvic floor disorders and diastasis recti abdominis: a systematic review and meta-analysis. Br J Sports Med. 2025 Mar 31;59(8):562-575. doi: 10.1136/bjsports-2024-108619.

  PMID: 39694630 BACKGROUND

• Romeikiene KE, Bartkeviciene D. Pelvic-Floor Dysfunction Prevention in Prepartum and Postpartum Periods. Medicina (Kaunas). 2021 Apr 16;57(4):387. doi: 10.3390/medicina57040387.

  PMID: 33923810 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Physical Therapy Modalities; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Electric Stimulation Therapy; Analgesia; Anesthesia and Analgesia

Study Officials

• Lina Būtėnaitė, MD, PhD

  Vilnius University

  STUDY CHAIR

• Daiva Bartkevičienė, Assoc. prof.

  Vilnius University

  STUDY DIRECTOR

• Eglė Pilkionytė, MD

  Vilnius University

  PRINCIPAL INVESTIGATOR

• Ivona Ivanovska, MD

  Vilnius University

  PRINCIPAL INVESTIGATOR

• Rūta Petravičienė

  Vilnius University

  PRINCIPAL INVESTIGATOR

• Karolina Eva Romeikienė, MD, PhD student

  Vilnius University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karolina Eva Romeikiene, Medical doctor, PHD student

CONTACT

+37060406142; eva.romeikiene@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrician-gynaecologist, PhD student, Karolina Eva Romeikiene

Model Details: Study participant will do two different options of training postpartum. Group one - training with specialist supervision Group two - self-training

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: February 23, 2026
• Study Start: January 30, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2029
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: It is planned around september 2027-2028
• Access Criteria: If other researches would like use data from this study they may ask for an IPD. Study protocol and results report will be shared with other researches as a future publication and in clinicaltrials.gov site.

Locations

LI (1)