Pelvic Floor DysfunctionDDDPREVNCT07426770
Comparison of Outpatient Rehabilitation Versus Self-training for the Treatment and Prevention of Postpartum Pelvic Floor Dysfunction
A study testing Rehabilitation postpartum and Self-training in people with Pelvic Floor Dysfunction and Postpartum Care, run by Vilnius University at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Dysfunction, Postpartum Care, Postpartum Comfort
- What is being tested?
- Rehabilitation postpartum and Self-training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteLithuania
- Study dates
- 30 Jan 2024to 30 Sep 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Younger than 18 years
- Twins or triplet pregnancy
- Contraindications for physical activity
- Connective tissue disorders
- Neurological disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University: study centers: "Vilnius University Hospital " Santaros Clinic", "Vilniaus Gimdymo Namai"
Vilnius
Karolina Eva Romeikiene, MD, PhD student, +37060406142, eva.romeikiene@gmail.com
About this study
Official title: 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.
Read more
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).
Read the 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.
- Conditions
- Pelvic Floor Dysfunction, Postpartum Care, Postpartum Comfort, Female Urinary Incontinence and Pelvic Organ Prolapse, Rectus Diastasis, Sexual Dysfunction Female
- Being tested
- Rehabilitation postpartum, Self-training
- Keywords
- Pelvic floor dysfunction postpartum, Postpartum urinary incontinence, Postpartum sexual dysfunction, Diastasis postpartum, Rehabilitation postpartum
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation postpartumBehavioural
Also called Physiotherapy, Biofeedback training, electrostimulation
- 4 Times biofeedback training
- 10 times physiotherapy with specialist
- 10 times transcutaneal electrostimulation (TENS)
Self-trainingBehavioural
Also called pelvic floor dysfunction app
- training at home after physiotherapist instructions
- using an app to record training frequency, length
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Self-training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in pelvic floor dysfunction symptoms
Self-reported improvement of symptoms (for example: pain, urinary incontinence, fecal incontinence, vaginal "laxity")
Measured: 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: 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: 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
Measured: 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: 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: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Age in years Advanced age is a risk factor for PFD
Measured: 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
Measured: 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
Measured: 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
Measured: Asked and documented at first postpartum visit, 6-8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start30 Jan 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participant will do two different options of training postpartum. Group one - training with specialist supervision Group two - self-training
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Vilnius University Hospital Santaros Klinikos, Vilnius Maternity Hospital
- Responsible party
- Principal investigator, Karolina Eva Romeikiene, Vilnius University
- Investigators
- Lina Būtėnaitė, MD, PhD, Study chair, Vilnius UniversityDaiva Bartkevičienė, Assoc. prof., Study director, Vilnius UniversityEglė Pilkionytė, MD, Principal investigator, Vilnius UniversityIvona Ivanovska, MD, Principal investigator, Vilnius UniversityRūta Petravičienė, Principal investigator, Vilnius UniversityKarolina Eva Romeikienė, MD, PhD student, Principal investigator, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426770
- Sponsor's protocol ID
- 2023/6-1527-986
- Other IDs
- Vilnius University, Vilnius University Hospital
- Acronym
- DDDPREV
- Status last verified
- Feb 2026
- First submitted
- 17 Jan 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers may share de-identified individual participant data such like: age, bmi, pop-q scores etc. In excell or other analyzable data set.
Publications
Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
PubMed 32378735Sigurdardottir 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.
PubMed 36995416Beamish 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.
PubMed 39694630Romeikiene KE, Bartkeviciene D. Pelvic-Floor Dysfunction Prevention in Prepartum and Postpartum Periods. Medicina (Kaunas). 2021 Apr 16;57(4):387. doi: 10.3390/medicina57040387.
PubMed 33923810