Post PartumPT-POSTPARTONCT03247660
Pelviperineal Physiotherapy in Postpartum
A study testing PFM training, HE and Educational strategy in people with Post Partum, run by University of Alcala at 1 site in Spain.
Trial summary
Objective: To compare the effectiveness of pelviperineal physiotherapy hypopressive exercise, and pelvic health education for the prevention and treatment of postpartum pelvic floor dysfunction in primiparous women after vaginal delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Post Partum
- What is being tested?
- PFM training, HE and Educational strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2017to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Postnatal women (6 and 8 weeks after vaginal delivery)
- Primiparous
- Whose vaginal delivery has occurred in the "Príncipe de Asturias" Hospital
- Women have not been already treated for pelvic floor dysfunction
- Women reading, understanding and freely signing an informed consent form
Who cannot join
- Postnatal women with medical diagnosis of pelvic floor dysfunction (PFD) prior to pregnancy and delivery
- Women with a history of conservative treatment or PFD surgery
- Women with concomitant or systemic disease that may affect the treatment (neurological, gynecological, urological or connective tissue), or with active or recurrent urinary infection without treatment at the time of the intervention proposed in this study, or hematuria.
- Women with perineal pain preventing vaginal dynamometry.
- Postnatal women with cognitive impairment or insufficient Spanish-language proficiency preventing adequate understanding of study procedures.
- Women with severe maternal complications or serious neonatal conditions.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Alcalá. FPSM research group. HUPA
Alcalá de Henares, Madrid, 28805
About this study
Official title: Effectiveness of the Perineal Physiotherapy in the Prevention and Treatment of Pelvic Floor Dysfunction in Postpartum
Objective: To compare the effectiveness of pelviperineal physiotherapy hypopressive exercise, and pelvic health education for the prevention and treatment of postpartum pelvic floor dysfunction in primiparous women after vaginal delivery.
Read the detailed description
Design: Randomized, controlled and single blinded clinical trial. Participants will be randomly assigned to one of these groups: Experimental group: pelviperineal physical therapy plus pelvic health education and training in the Knack manoeuvre; Experimental group II: hypopressive exercises plus pelvic health education and training in the Knack manoeuvre; Control group: pelvic health education, training in the Knack manoeuvre, and general recommendations for pelvic floor muscle exercises at home. In the 3 groups several physical therapy assessments will be undertaken: 1st before intervention, 2nd immediately after completing intervention; 3th, 4th, 5th and 6th after 3, 6 and12 months. Study subjects: Postnatal women (6 and 8 weeks after vaginal delivery), primiparous, whose vaginal delivery has occurred in the "PrÍncipe de Asturias" Hospital, which have not been already treated for pelvic floor dysfunction, and after reading, understanding and freely signing an informed consent form. Sample size: The sample size was calculated a priori using the PFDI-20 as the primary outcome. Based on a clinically meaningful between-group difference of 20 points and an SD of change of 31.2 points, 55 participants per group were required. A total of 165 participants were randomized (55 per group). Data analysis: A descriptive analysis will be performed for all variables. Intervention effects will be assessed using linear mixed-effects models for change from baseline, including group, time, and group-by-time interaction as fixed effects, with adjustment for the centered baseline value of the outcome and a participant-specific random intercept. A two-sided significance level of 0.05 will be used.
- Conditions
- Post Partum
- Being tested
- PFM training, HE, Educational strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFM trainingOther
Also called Pelvic floor muscle training
See information included in arm/group descriptions.
HEOther
Also called Hypopressive exercises
See information included in arm/group descriptions.
Educational strategyBehavioural
See information included in arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Pelviperineal physiotherapy (PP) group | Experimental | An individualised pelvic floor muscle training (PFMT) programme will be applied. Participants will performed PFM exercises in the way proposed by the PERFECT scheme. Biofeedback exercises will be also performed in lithotomy position. If the evolution of the women will allow it, the last two treatment biofeedback sessions will be conducted in standing position, to train PFM in more challenging and functional situation. Active intravaginal electrical stimulation will also be applied when PFM strength was <3 on the Modified Oxford Scale. Participants also received pelvic health education, standardised instruction in the Knack manoeuvre, and an individualised home exercise programme. Educational strategy will also be applied. The intervention will last 8 weeks, 2 sessions per week. Each session will last 60 minutes. Receives: Other: PFM training; Other: HE; Behavioral: Educational strategy |
| Hypopressive exercices (HE) group | Experimental | Women will be instructed in thirty-three Hypopressives exercises (HE) described by the developer of the Hypopressive Abdominal Gymnastics, Dr. Caufriez plus pelvic health education, standardised instruction in the Knack manoeuvre, and individualised home practice were also provided.
The intervention will last 8 weeks, 2 sessions per week. Each session will last 60 minutes. Receives: Other: HE; Behavioral: Educational strategy |
| Control group | Active comparator | The educational strategy will consist of instruction of printed materials and dimensional anatomical models about the anatomy of the pelvic floor and the physiology of the pelvic organs. It will be recommended to avoid risk factors, such as gaining weight, weight lifting, high impact sports, constipation, smoking, or drinking too much caffeine. They will also instruct in toilet habits, standardised instruction in the Knack manoeuvre, and general recommendations for PFM exercise at home. No supervised or individualised PFMT or hypopressive exercise was provided. The intervention will last 8 weeks, 1 session per week. Each session will last 50 minutes. Receives: Behavioral: Educational strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptoms and quality of life
It will be assessed by PFDI-20 Spanish version that is both a symptom inventory and a measure of the degree of bother and distress caused by pelvic floor symptoms. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300 and the higher the score, the worse quality of life. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions collecting data about UI, POP and colorectal and anal symptoms.
Measured: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Secondary outcomes (4)
Change in life impact of pelvic floor dysfunction
It will be assessed by the PFIQ-7 Spanish version. The PFIQ-7 consists of 3 scales of 7 questions each taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire. The 3 scales are scored from 0 (least impact) to 100 (greatest impact) and an overall summary score (0 to 300).
Measured: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Pelvic floor muscle contraction and strenght
Vaginal palpation will qualify PFM contraction and strength. using the Modified Oxford Score ranging from 0 to 5, according to the muscles contraction and strength.
Measured: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Changes in sexual function
It will be assessed using the Spanish version of the Female Sexual Function Index (FSFI). The FSFI consists of 19 items assessing six domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain, with higher scores indicating better sexual function.
Measured: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Change in pelvic floor muscle strength and tone
It will be measured with dynamometry (gr)
Measured: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start10 Oct 2017
- Primary completion20 Dec 2023
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post PartumStudies 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
- 3 groups: 2 experimental groups and 1 control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Torres Lacomba, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247660
- Sponsor's protocol ID
- 21/2013
- Other IDs
- PI17/01449
- Acronym
- PT-POSTPARTO
- Status last verified
- Jan 2024
- First submitted
- 5 Aug 2017
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 32378735
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Perineal Physiotherapy in the Prevention and Treatment of Pelvic Floor Dysfunction in Postpartum
- ClinicalTrials.gov ID
- NCT03247660
- Acronym / sponsor ID
- PT-POSTPARTO / 21/2013
- Conditions
- Post Partum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To compare the effectiveness of pelviperineal physiotherapy hypopressive exercise, and pelvic health education for the prevention and treatment of postpartum pelvic floor dysfunction in primiparous women after vaginal delivery.
Detailed description
Design: Randomized, controlled and single blinded clinical trial. Participants will be randomly assigned to one of these groups: Experimental group: pelviperineal physical therapy plus pelvic health education and training in the Knack manoeuvre; Experimental group II: hypopressive exercises plus pelvic health education and training in the Knack manoeuvre; Control group: pelvic health education, training in the Knack manoeuvre, and general recommendations for pelvic floor muscle exercises at home. In the 3 groups several physical therapy assessments will be undertaken: 1st before intervention, 2nd immediately after completing intervention; 3th, 4th, 5th and 6th after 3, 6 and12 months. Study subjects: Postnatal women (6 and 8 weeks after vaginal delivery), primiparous, whose vaginal delivery has occurred in the "PrÍncipe de Asturias" Hospital, which have not been already treated for pelvic floor dysfunction, and after reading, understanding and freely signing an informed consent form. Sample size: The sample size was calculated a priori using the PFDI-20 as the primary outcome. Based on a clinically meaningful between-group difference of 20 points and an SD of change of 31.2 points, 55 participants per group were required. A total of 165 participants were randomized (55 per group). Data analysis: A descriptive analysis will be performed for all variables. Intervention effects will be assessed using linear mixed-effects models for change from baseline, including group, time, and group-by-time interaction as fixed effects, with adjustment for the centered baseline value of the outcome and a participant-specific random intercept. A two-sided significance level of 0.05 will be used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3 groups: 2 experimental groups and 1 control group
| Arm | Type | Receives |
|---|---|---|
| Pelviperineal physiotherapy (PP) group | Experimental | Other: PFM training, Other: HE, Behavioral: Educational strategyAn individualised pelvic floor muscle training (PFMT) programme will be applied. Participants will performed PFM exercises in the way proposed by the PERFECT scheme. Biofeedback exercises will be also performed in lithotomy position. If the evolution of the women will allow it, the last two treatment biofeedback sessions will be conducted in standing position, to train PFM in more challenging and functional situation. Active intravaginal electrical stimulation will also be applied when PFM strength was <3 on the Modified Oxford Scale. Participants also received pelvic health education, standardised instruction in the Knack manoeuvre, and an individualised home exercise programme. Educational strategy will also be applied. The intervention will last 8 weeks, 2 sessions per week. Each session will last 60 minutes. |
| Hypopressive exercices (HE) group | Experimental | Other: HE, Behavioral: Educational strategyWomen will be instructed in thirty-three Hypopressives exercises (HE) described by the developer of the Hypopressive Abdominal Gymnastics, Dr. Caufriez plus pelvic health education, standardised instruction in the Knack manoeuvre, and individualised home practice were also provided. The intervention will last 8 weeks, 2 sessions per week. Each session will last 60 minutes. |
| Control group | Active comparator | Behavioral: Educational strategyThe educational strategy will consist of instruction of printed materials and dimensional anatomical models about the anatomy of the pelvic floor and the physiology of the pelvic organs. It will be recommended to avoid risk factors, such as gaining weight, weight lifting, high impact sports, constipation, smoking, or drinking too much caffeine. They will also instruct in toilet habits, standardised instruction in the Knack manoeuvre, and general recommendations for PFM exercise at home. No supervised or individualised PFMT or hypopressive exercise was provided. The intervention will last 8 weeks, 1 session per week. Each session will last 50 minutes. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Postnatal women (6 and 8 weeks after vaginal delivery)
- Primiparous
- Whose vaginal delivery has occurred in the "Príncipe de Asturias" Hospital
- Women have not been already treated for pelvic floor dysfunction
- Women reading, understanding and freely signing an informed consent form
Key exclusion criteria (6 listed)
- Postnatal women with medical diagnosis of pelvic floor dysfunction (PFD) prior to pregnancy and delivery
- Women with a history of conservative treatment or PFD surgery
- Women with concomitant or systemic disease that may affect the treatment (neurological, gynecological, urological or connective tissue), or with active or recurrent urinary infection without treatment at the time of the intervention proposed in this study, or hematuria.
- Women with perineal pain preventing vaginal dynamometry.
- Postnatal women with cognitive impairment or insufficient Spanish-language proficiency preventing adequate understanding of study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFM trainingAlso: Pelvic floor muscle trainingSee information included in arm/group descriptions. | Other | Pelviperineal physiotherapy (PP) group |
| HEAlso: Hypopressive exercisesSee information included in arm/group descriptions. | Other | Hypopressive exercices (HE) group, Pelviperineal physiotherapy (PP) group |
| Educational strategySee information included in arm/group descriptions. | Behavioural | Control group, Hypopressive exercices (HE) group, Pelviperineal physiotherapy (PP) group |
Primary outcome
Change in symptoms and quality of life
Time frame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
It will be assessed by PFDI-20 Spanish version that is both a symptom inventory and a measure of the degree of bother and distress caused by pelvic floor symptoms. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300 and the higher the score, the worse quality of life. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions collecting data about UI, POP and colorectal and anal symptoms.
4 secondary outcomes
Change in life impact of pelvic floor dysfunction
Time frame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Pelvic floor muscle contraction and strenght
Time frame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Changes in sexual function
Time frame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Change in pelvic floor muscle strength and tone
Time frame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Derived from this study: PubMed 32378735Woodley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFM training, HE and Educational strategy in people with Post Partum, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptoms and quality of life (time frame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03247660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.