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

Prevention of Female Pelvic Floor Dysfunction Rehabilitation Postpartum.

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).

Study Overview

• Status: Recruiting
• Conditions: Pelvic Floor Dysfunction; Postpartum Care; Rectus Diastasis; Sexual Dysfunction Female; Female Urinary Incontinence and Pelvic Organ Prolapse; Postpartum Comfort
• Intervention / Treatment: Behavioral: Rehabilitation postpartum; Behavioral: Self-training

Detailed Description

Objectives of the Biomedical Research:

• To evaluate gynaecological examination data at 6-8 weeks postpartum, with additional assessment of: experienced pelvic floor dysfunction (PFD) symptoms and their impact on quality of life, pelvic organ positioning (Pelvic Organ Prolapse Quantification system - POP-Q), pelvic floor muscle (PFM) strength, fecal incontinence, diastasis recti abdominis (DRA), and pelvic/perineal ultrasound findings.
• To evaluate patient examination data conducted by a physical medicine and rehabilitation physician and a physiotherapist at 6-10 weeks postpartum.
• To assess changes in pelvic floor muscle activity, PFD symptoms, pelvic organ position, following the training procedures and at 6 and 12 months post-intervention.
• To compare changes among two groups:

Supervised training (specialist-led);

Self-training at home (based on specialist recommendations);

• To compare gynecological examination data, Oxford Scale scores, and St. Mark's scores among the study groups.
• To compare changes in women's quality of life, sexual function, and clinical outcomes between the study groups based on validated questionnaires.
• To develop recommendations for specialists and the public regarding the prevention of postpartum pelvic floor dysfunction based on the study findings.

Comprehensive Description of Evaluated Outcomes Primary and Secondary Study Endpoints

Primary Endpoints: Changes indicating the effect of applied rehabilitation measures on the reduction and prevention of pelvic dysfunction symptoms:

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

Change in POP-Q scores.

St. Mark's Score for fecal incontinence: evaluating the change in score over the course of the study.

Pelvic and perineal ultrasound data: assessing symmetrical PFM contraction, changes in vaginal hiatus width, and urethral mobility. Comparison of results between study groups.

Persistence of PFD symptoms as reported by patients.

Changes in Quality of Life (QoL) and clinical outcome questionnaires: * ICIQ-UI SF (International Consultation on Incontinence Questionnaire Short Form); 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).

Changes in musculoskeletal functions: * Objective assessment of PFM state via contraction force and Pressure Biofeedback activity evaluation.

Assessment of diastasis recti abdominis using palpation and ultrasound.

Pain assessment (abdominal, perineal, pelvic, pubic symphysis, and lumbosacral) using the Visual Analogue Scale (VAS).

Evaluation of gait, balance, and coordination.

Core stability and transversus abdominis activity (using a stabilizer); static endurance tests for abdominal and back muscles.

Secondary Endpoints: Factors potentially influencing the effectiveness of the rehabilitation program:

Demographics and History: Mean age, BMI, parity (number of pregnancies/deliveries), neonatal weight, and head circumference.

Obstetric Factors: Mode of delivery, delivery-related factors (induction, gestational age, fetal presentation, delivery method: natural, ventouse, c-section).

Pathologies: Pregnancy-related diseases (nausea/vomiting, intrahepatic cholestasis, preeclampsia, gestational diabetes), infectious/inflammatory diseases during pregnancy.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karolina Eva Romeikiene, Medical doctor, PHD student; Phone Number: +37060406142; Email: eva.romeikiene@gmail.com

Study Locations

• Lithuania
  • Vilnius, Lithuania
    • Recruiting
    • Vilnius University: study centers: "Vilnius University Hospital " Santaros Clinic", "Vilniaus Gimdymo Namai"
    • Contact: Karolina Eva Romeikiene, MD, PhD student; Phone Number: +37060406142; Email: eva.romeikiene@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group of participants getting specialist supervised training postpartum; Woman 6-10 weeks postpartum starts training program with physiotherapist and physical medicine and rehabilitation physician supervision.	Behavioral: Rehabilitation postpartum; 4 Times biofeedback training; 10 times physiotherapy with specialist; 10 times transcutaneal electrostimulation (TENS); Other Names: Physiotherapy; electrostimulation; Biofeedback training
Other: Group of participants doing self-training with an app; 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; training at home after physiotherapist instructions; using an app to record training frequency, length; Other Names: pelvic floor dysfunction app

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors potentially influencing the effectiveness of the rehabilitation program: mean age	Age in years Advanced age is a risk factor for PFD	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	BMI (kg/m^2) Higher BMI is a risk factor for PFD	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	Number of births (after 22 gestational weeks) Higher number of births is a risk factor for PFD	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	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	Asked and documented at first postpartum visit, 6-8 weeks postpartum

Collaborators and Investigators

• Sponsor: Vilnius University
• Collaborators: Vilnius University Hospital Santaros Klinikos; Vilnius Maternity Hospital
• Investigators: Study Chair: Lina Būtėnaitė, MD, PhD, Vilnius University; Study Director: Daiva Bartkevičienė, Assoc. prof., Vilnius University; Principal Investigator: 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

Publications and helpful links

General Publications

• 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
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: January 17, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pelvic floor dysfunction postpartum; Postpartum urinary incontinence; Postpartum sexual dysfunction; Diastasis postpartum; Rehabilitation postpartum
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pathological Conditions, Signs and Symptoms; Pelvic Organ Prolapse; Therapeutics; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Analgesia; Transcutaneous Electric Nerve Stimulation; Physical Therapy Modalities
• Other Study ID Numbers: 2023/6-1527-986; Vilnius University (Other Identifier: Vilnius University is responsible for this study (Bioethics, study enrolment)); Vilnius University Hospital (Other Identifier: This study is going in Vilnius University Hospital "Santaros Clinic" and "Vilniaus gimdymo namai")

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Researchers may share de-identified individual participant data such like: age, bmi, pop-q scores etc. In excell or other analyzable data set.
• IPD Sharing Time Frame: It is planned around september 2027-2028
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No