Pelvic Floor DisordersNoRForNCT04098965
Treatment of Scars and Dysfunctions of the Pelvic Floor in Postpartum
A study testing Pysiotherapy techniques and physician treatment in people with Pelvic Floor Disorders, run by Universidad de León at 1 site in Spain.
Trial summary
Recruitment of patients who have suffered third- and fourth-degree perineal tear during childbirth, and who have given birth at the Hospital Universitario Marqués de Valdecilla (Santander, Spain). Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Pysiotherapy techniques and physician treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jul 2017to Jul 2020
- 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 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who have dysfunctions in the pelvic floor after childbirth
- Patients who have given birth at the Hospital Universitario Marqués de Valdecilla
- Patients who do not have any medical alteration that does not indicate the treatment
Who cannot join
- Patients who do not have pelvic floor dysfunctions after childbirth
- Patients who have not given birth at the Hospital Universitario Marqués de Valdecilla
- Patients who have any medical changes that counter the treatment
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Sierrallana
Torrelavega, Cantabria, 39300
M. Pilar Vidales Colinas, +34 616965978, pilarvidacoli@hotmail.com
María del Pilar Vidales Colinas
About this study
Official title: Treatment of Scarring and Dysfunction of the Pelvic Floor in Postpartum, Through Physical Therapy or by Medical Recommendations in Consultation
Recruitment of patients who have suffered third- and fourth-degree perineal tear during childbirth, and who have given birth at the Hospital Universitario Marqués de Valdecilla (Santander, Spain). They are distributed randomly in two groups an experimental group who apply techniques of physiotherapy and a control group, receiving medical treatment.
At the same time is recruited the same number of patients who have not suffered tear and whose birth has been instrumental, dividing into two groups, control and experimental. And the same number of patients who have given birth but have not suffered tear or instrumental delivery, divided also into control group and experimental.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Pysiotherapy techniques, physician treatment
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pysiotherapy techniquesOther
manual therapy techniques, postural re-education and muscle strengthening
physician treatmentOther
hygienic-dietary recommendations, Kegel exercises and pain relievers
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Physical Therapy Techniques Receives: Other: Pysiotherapy techniques |
| Control | Other | physician treatment Receives: Other: physician treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in VAS from the start to the end
Pain
Measured: in the begining, at thirth month, at sixth month and at the finish (one year later)
Change in SF36 from de start to the end
quality of life sorth form
Measured: in the begining, at thirth month, at sixth month and at the finish (one year later)
Change in EPIQ from de start to the end
Epidemiology of Prolapse and Incontinence Questionnaire
Measured: in the begining, at thirth month, at sixth month and at the finish (one year later)
Change in OXFORD from the start to the end
muscle strength
Measured: in the begining, at thirth month, at sixth month and at the finish (one year later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start20 Jul 2017
- Primary completion20 Jul 2018
- Study completionJul 2020 (estimated)
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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de León
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARÍA DEL PILAR VIDALES COLINAS, Universidad de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098965
- Sponsor's protocol ID
- 321311: FISIOTERAPIA
- Acronym
- NoRFor
- Status last verified
- Sep 2019
- First submitted
- 17 Sep 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Scarring and Dysfunction of the Pelvic Floor in Postpartum, Through Physical Therapy or by Medical Recommendations in Consultation
- ClinicalTrials.gov ID
- NCT04098965
- Acronym / sponsor ID
- NoRFor / 321311: FISIOTERAPIA
- Conditions
- Pelvic Floor Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universidad de LeónUniversity, hospital or other
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- Jul 2020 (estimated)
- First posted
- 23 Sep 2019 (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.
Recruitment of patients who have suffered third- and fourth-degree perineal tear during childbirth, and who have given birth at the Hospital Universitario Marqués de Valdecilla (Santander, Spain). They are distributed randomly in two groups an experimental group who apply techniques of physiotherapy and a control group, receiving medical treatment.
At the same time is recruited the same number of patients who have not suffered tear and whose birth has been instrumental, dividing into two groups, control and experimental. And the same number of patients who have given birth but have not suffered tear or instrumental delivery, divided also into control group and experimental.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Pysiotherapy techniquesPhysical Therapy Techniques |
| Control | Other | Other: physician treatmentphysician treatment |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients who have dysfunctions in the pelvic floor after childbirth
- Patients who have given birth at the Hospital Universitario Marqués de Valdecilla
- Patients who do not have any medical alteration that does not indicate the treatment
Key exclusion criteria (3 listed)
- Patients who do not have pelvic floor dysfunctions after childbirth
- Patients who have not given birth at the Hospital Universitario Marqués de Valdecilla
- Patients who have any medical changes that counter the treatment
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 |
|---|---|---|
| Pysiotherapy techniquesmanual therapy techniques, postural re-education and muscle strengthening | Other | Experimental |
| physician treatmenthygienic-dietary recommendations, Kegel exercises and pain relievers | Other | Control |
Primary outcome
change in VAS from the start to the end
Time frame: in the begining, at thirth month, at sixth month and at the finish (one year later)
Pain
Change in SF36 from de start to the end
Time frame: in the begining, at thirth month, at sixth month and at the finish (one year later)
quality of life sorth form
Change in EPIQ from de start to the end
Time frame: in the begining, at thirth month, at sixth month and at the finish (one year later)
Epidemiology of Prolapse and Incontinence Questionnaire
Change in OXFORD from the start to the end
Time frame: in the begining, at thirth month, at sixth month and at the finish (one year later)
muscle strength
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pysiotherapy techniques and physician treatment in people with Pelvic Floor Disorders, run by Universidad de León 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M. Pilar Master (+34616965978, pilarvidacoli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in VAS from the start to the end (time frame: in the begining, at thirth month, at sixth month and at the finish (one year later)). The study lists 4 primary outcomes in all. 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 23 Sep 2019.