Pelvic Floor DisordersNCT03592160
Role of Rehabilitation for the Repair of Pelvic Floor Injuries Associated to Vaginal Delivery Identified by 3/4D Transperineal Ultrasound
A study testing Physiotherapy treatment in people with Pelvic Floor Disorders and Ultrasound Therapy; Complications, run by Hospital Universitario de Valme at 1 site in Spain.
Trial summary
SUMMARY: (Objective, design, scope of the study, subjects of study, instrumentation, results, conclusions) Objectives: To evaluate if the physiotherapy treatment in pelvic floor dysfunctions, identified by transperineal ultrasound 3 / 4D, in postpartum improve the tone and functionality of pelvic floor. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Floor Disorders, Ultrasound Therapy; Complications, Physical Disorder
- What is being tested?
- Physiotherapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2016to 30 Sep 2016
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Vaginal delivery
- Cephalic presentation
- Primiparity
- At term gestation (37-42 weeks)
- No prior pelvic floor corrective surgery
- Written informed consent
Who cannot join
- Pregnancies with severe maternal or fetal pathology
Trial locations and contacts
1 site in 1 country.
About this study
SUMMARY: (Objective, design, scope of the study, subjects of study, instrumentation, results, conclusions)
Objectives: To evaluate if the physiotherapy treatment in pelvic floor dysfunctions, identified by transperineal ultrasound 3 / 4D, in postpartum improve the tone and functionality of pelvic floor.
Read more
Design: Post-authorization, prospective, longitudinal randomized intervention study
Scope: Full-term deliveries at the University Hospital. Subjects of study: Full-term primiparous and full-term pregnancies with pelvic floor lesion, identified by transperineal ultrasound 3 / 4D, which are randomized between the physiotherapy treatment of pelvic floor and the non-work.
Variables: Primary variable: Assess the improvement in contractility / tone, evaluation by manometry and assess the anatomical improvement of the area of ?? the genital hiatus, stay by transperineal ultrasound 3 / 4D. Secondary variables: Identify the levator ani muscle injury rate, estimate the sonographic changes in the levator ani muscle through rehabilitation. Analyze the improvement of the symptoms associated with the public organic prolapse and evaluate the improvement of the quality of life.
Data analysis: To detect a difference of 10% in the reduction of the size of the index between the study groups (not intervened / intervened) after 6 months of intervention, standard deviation 10%, Error-alpha 5%, Error- beta 10% (P90%) we need 23 women in each group. Assuming a loss of 10% in the follow-up, the final size would be 52 women, 26 per group.
- Conditions
- Pelvic Floor Disorders, Ultrasound Therapy; Complications, Physical Disorder, Obstetric Labor Complications
- Being tested
- Physiotherapy treatment
- Medical subject headings
- Pelvic Floor Disorders, Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy treatmentOther
Physiotherapy treatment consisted of pelvic floor exercises assisted by manometric biofeedback. In addition, active lumbopelvic stabilization exercises, including the contraction of pelvic floor muscles was performed in supine, plank and quadruped position.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The therapy lasted two months, at a rate of two sessions per week, with a duration of 45 minutes per session. The program consisted of pelvic floor exercises assisted by manometric biofeedback, which were performed in supine position for 20 minutes. In addition, active lumbopelvic stabilization exercises, including the contraction of pelvic floor muscles was performed in supine, plank and quadruped position.
Together with the treatment at the clinic, patients were asked to perform a series of exercises at home, consisting in: 8-12 sustained contractions of 6 seconds, with a subsequent rest period of double the work-time, followed by 3-5 fast contractions of 2 seconds with maximum intensity, resting double the work-time. Domiciliary exercises were performed in supine, siting and standing position. Receives: Other: Physiotherapy treatment |
| Control group | No intervention | The control group received an information brochure with recommendations, including the same program of pelvic floor exercises taught to the patients in the experimental group, but without carrying out any kind of supervision by the physiotherapist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contractility
Assess the improvement in contractility / tone, evaluated by manometry, of the pelvic floor produced by the treatment of postpartum physiotherapy of the pelvic floor.
Measured: 6 months after randomisation
Secondary outcomes (1)
Changes in the levator ani muscle
To estimate the ultrasonographic changes in the levator ani muscle after rehabilitation, determining the maximum thicknesses and levator ani muscle area.
Measured: 6 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Jan 2016
- Primary completion1 Aug 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Valme
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, José Antonio García Mejido, Hospital Universitario de Valme
- Investigators
- José Antonio García Mejido, Principal investigator, Hospital Universitario Nuestra Señora de Valme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592160
- Sponsor's protocol ID
- Rehabilitación avulsion
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2018
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Rehabilitation for the Repair of Pelvic Floor Injuries Associated to Vaginal Delivery Identified by 3/4D Transperineal Ultrasound
- ClinicalTrials.gov ID
- NCT03592160
- Acronym / sponsor ID
- Rehabilitación avulsion
- Conditions
- Pelvic Floor Disorders, Ultrasound Therapy; Complications, Physical Disorder, Obstetric Labor Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hospital Universitario de ValmeUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 19 Jul 2018 (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.
SUMMARY: (Objective, design, scope of the study, subjects of study, instrumentation, results, conclusions)
Objectives: To evaluate if the physiotherapy treatment in pelvic floor dysfunctions, identified by transperineal ultrasound 3 / 4D, in postpartum improve the tone and functionality of pelvic floor.
Design: Post-authorization, prospective, longitudinal randomized intervention study
Scope: Full-term deliveries at the University Hospital. Subjects of study: Full-term primiparous and full-term pregnancies with pelvic floor lesion, identified by transperineal ultrasound 3 / 4D, which are randomized between the physiotherapy treatment of pelvic floor and the non-work.
Variables: Primary variable: Assess the improvement in contractility / tone, evaluation by manometry and assess the anatomical improvement of the area of ?? the genital hiatus, stay by transperineal ultrasound 3 / 4D. Secondary variables: Identify the levator ani muscle injury rate, estimate the sonographic changes in the levator ani muscle through rehabilitation. Analyze the improvement of the symptoms associated with the public organic prolapse and evaluate the improvement of the quality of life.
Data analysis: To detect a difference of 10% in the reduction of the size of the index between the study groups (not intervened / intervened) after 6 months of intervention, standard deviation 10%, Error-alpha 5%, Error- beta 10% (P90%) we need 23 women in each group. Assuming a loss of 10% in the follow-up, the final size would be 52 women, 26 per group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Physiotherapy treatmentThe therapy lasted two months, at a rate of two sessions per week, with a duration of 45 minutes per session. The program consisted of pelvic floor exercises assisted by manometric biofeedback, which were performed in supine position for 20 minutes. In addition, active lumbopelvic stabilization exercises, including the contraction of pelvic floor muscles was performed in supine, plank and quadruped position. Together with the treatment at the clinic, patients were asked to perform a series of exercises at home, consisting in: 8-12 sustained contractions of 6 seconds, with a subsequent rest period of double the work-time, followed by 3-5 fast contractions of 2 seconds with maximum intensity, resting double the work-time. Domiciliary exercises were performed in supine, siting and standing position. |
| Control group | No intervention | –The control group received an information brochure with recommendations, including the same program of pelvic floor exercises taught to the patients in the experimental group, but without carrying out any kind of supervision by the physiotherapist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Vaginal delivery
- Cephalic presentation
- Primiparity
- At term gestation (37-42 weeks)
- No prior pelvic floor corrective surgery
Key exclusion criteria (1 listed)
- Pregnancies with severe maternal or fetal pathology
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 |
|---|---|---|
| Physiotherapy treatmentPhysiotherapy treatment consisted of pelvic floor exercises assisted by manometric biofeedback. In addition, active lumbopelvic stabilization exercises, including the contraction of pelvic floor muscles was performed in supine, plank and quadruped position. | Other | Experimental group |
Primary outcome
Contractility
Time frame: 6 months after randomisation
Assess the improvement in contractility / tone, evaluated by manometry, of the pelvic floor produced by the treatment of postpartum physiotherapy of the pelvic floor.
1 secondary outcome
Changes in the levator ani muscle
Time frame: 6 months after randomisation
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 20 Jul 2018.
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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.
José Antonio García Mejido principal investigator
Hospital Universitario Nuestra Señora de Valme
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy treatment in people with Pelvic Floor Disorders and Ultrasound Therapy; Complications, run by Hospital Universitario de Valme 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 6 inclusion and 1 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 20 Jul 2018. 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?
Contractility (time frame: 6 months after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2018.