Pelvic Floor DisordersPerineUMNCT05399901
M-mode Ultrasonography in the Assessment and Treatment of Pelviperineal Dysfunctions (PerineUM)
A study testing Electromyographic biofeedback and M-mode US biofeedback in people with Pelvic Floor Disorders, run by Universidad de Murcia.
Trial summary
Objectives: To analyze the Mode M ultrasound use in the assessment of pelvic floor musculature (PFM) and in the rehabilitation of motor control in pelviperineal dysfunctions that affect the support of pelvic organs, urinary and fecal continence and reproductive and sexual functions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Electromyographic biofeedback and M-mode US biofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Oct 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with pelvic floor dysfunction derived from the pelvic floor unit of HLA La Vega in the city of Murcia diagnosed by the doctor and without previous training in pelvic floor muscles contraction.
Who cannot join
- Pregnancy, a history of pelvic floor surgery in the previous year, neurological injury with affectation of the sacral reflex from S2 to S4, previous delivery in a period of less than 6 weeks or known or suspected urinary tract infection.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Use of Transabdominal M-mode Ultrasonography in the Assessment and Treatment of Pelviperineal Dysfunctions
Objectives: To analyze the Mode M ultrasound use in the assessment of pelvic floor musculature (PFM) and in the rehabilitation of motor control in pelviperineal dysfunctions that affect the support of pelvic organs, urinary and fecal continence and reproductive and sexual functions.
Methodology: A cross-sectional descriptive study will be followed by a randomized clinical trial. There will be two samples: a sample of volunteers without PFM dysfunction; and a sample of patients with pelviperineal dysfunction derived from health centers in the Region of Murcia. An intra- and interobserver reliability study of transabdominal M-mode ultrasound of PFM will be performed. Then, a cross-sectional descriptive study of the functional behavior of PFM will be used in different functional situations such as: voluntary contraction at maximum force, fast contraction, Valsalva maneuver and forced cough. The following ultrasound variables will be measured: direction and amount of displacement, speed of displacement and time of contraction. Correlations between ultrasound variables and sociodemographic and clinical variables will be analyzed. The randomized clinical trial will compare a PFM contraction awareness treatment based on endocavitary digital contact with a motor learning program based on transabdominal mode M ultrasound biofeedback.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Electromyographic biofeedback, M-mode US biofeedback
- 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.
Electromyographic biofeedbackOther
Active exercises of the pelvic floor muscles and verbal instructions and EMG Biofeedback
M-mode US biofeedbackOther
Active exercises of the pelvic floor muscles and verbal instructions and M-mode Ultrasound Biofeedback
| Study group | Role | What they receive |
|---|---|---|
| EMG BFB | Experimental | An educational program will be implemented, and active exercises of the PFM will be performed using verbal instructions together with electromyographic biofeedback (BFB). Receives: Other: Electromyographic biofeedback |
| M-mode US | Experimental | An educational program will be implemented, and active exercises of the PFM will be performed using verbal instructions together with transabdominal M-mode ultrasound biofeedback (US). Receives: Other: M-mode US biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the self efficacy expectations in performing pelvic floor exercises.
It will be assessed by the Broome Pelvic Muscle Self-Efficacy Scale (PMSES) Spanish version. Self-efficacy expectations, specifically for performing pelvic floor exercises, are measured with 14 items with responses between 0 and 100. One hundred represents high level of confidence.
Measured: At baseline and after the intervention (1 week from baseline)
Changes in the outcome expectations for pelvic-floor exercise treatment.
It will be assessed by the Broome Pelvic Muscle Self-Efficacy Scale (PMSES) Spanish version. Outcome expectations are measured with 9 items with responses between 0 and 100. One hundred represents high level of confidence.
Measured: At baseline and after the intervention (1 week from baseline)
Secondary outcomes (1)
Change in the displacement of the base of the bladder during voluntary contraction of the pelvic floor.
It will be measured by Ultrasonography.
Measured: At baseline and after the intervention (1 hour from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2024 (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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Elena del Baño-Aledo, Universidad de Murcia
- Investigators
- MARIA ELENA DEL BAÑO ALEDO, PhD, Principal investigator, Murcia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399901
- Sponsor's protocol ID
- PerineUM2022
- Acronym
- PerineUM
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Transabdominal M-mode Ultrasonography in the Assessment and Treatment of Pelviperineal Dysfunctions
- ClinicalTrials.gov ID
- NCT05399901
- Acronym / sponsor ID
- PerineUM / PerineUM2022
- Conditions
- Pelvic Floor Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 1 Jun 2022 (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.
Objectives: To analyze the Mode M ultrasound use in the assessment of pelvic floor musculature (PFM) and in the rehabilitation of motor control in pelviperineal dysfunctions that affect the support of pelvic organs, urinary and fecal continence and reproductive and sexual functions.
Methodology: A cross-sectional descriptive study will be followed by a randomized clinical trial. There will be two samples: a sample of volunteers without PFM dysfunction; and a sample of patients with pelviperineal dysfunction derived from health centers in the Region of Murcia. An intra- and interobserver reliability study of transabdominal M-mode ultrasound of PFM will be performed. Then, a cross-sectional descriptive study of the functional behavior of PFM will be used in different functional situations such as: voluntary contraction at maximum force, fast contraction, Valsalva maneuver and forced cough. The following ultrasound variables will be measured: direction and amount of displacement, speed of displacement and time of contraction. Correlations between ultrasound variables and sociodemographic and clinical variables will be analyzed. The randomized clinical trial will compare a PFM contraction awareness treatment based on endocavitary digital contact with a motor learning program based on transabdominal mode M ultrasound biofeedback.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMG BFB | Experimental | Other: Electromyographic biofeedbackAn educational program will be implemented, and active exercises of the PFM will be performed using verbal instructions together with electromyographic biofeedback (BFB). |
| M-mode US | Experimental | Other: M-mode US biofeedbackAn educational program will be implemented, and active exercises of the PFM will be performed using verbal instructions together with transabdominal M-mode ultrasound biofeedback (US). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with pelvic floor dysfunction derived from the pelvic floor unit of HLA La Vega in the city of Murcia diagnosed by the doctor and without previous training in pelvic floor muscles contraction.
Key exclusion criteria (1 listed)
- Pregnancy, a history of pelvic floor surgery in the previous year, neurological injury with affectation of the sacral reflex from S2 to S4, previous delivery in a period of less than 6 weeks or known or suspected urinary tract infection.
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 |
|---|---|---|
| Electromyographic biofeedbackActive exercises of the pelvic floor muscles and verbal instructions and EMG Biofeedback | Other | EMG BFB |
| M-mode US biofeedbackActive exercises of the pelvic floor muscles and verbal instructions and M-mode Ultrasound Biofeedback | Other | M-mode US |
Primary outcome
Changes in the self efficacy expectations in performing pelvic floor exercises.
Time frame: At baseline and after the intervention (1 week from baseline)
It will be assessed by the Broome Pelvic Muscle Self-Efficacy Scale (PMSES) Spanish version. Self-efficacy expectations, specifically for performing pelvic floor exercises, are measured with 14 items with responses between 0 and 100. One hundred represents high level of confidence.
Changes in the outcome expectations for pelvic-floor exercise treatment.
Time frame: At baseline and after the intervention (1 week from baseline)
It will be assessed by the Broome Pelvic Muscle Self-Efficacy Scale (PMSES) Spanish version. Outcome expectations are measured with 9 items with responses between 0 and 100. One hundred represents high level of confidence.
1 secondary outcome
Change in the displacement of the base of the bladder during voluntary contraction of the pelvic floor.
Time frame: At baseline and after the intervention (1 hour from baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- 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.
MARIA ELENA DEL BAÑO ALEDO, PhD principal investigator
Murcia University
Questions about this trial
What is this clinical trial studying?
A study testing Electromyographic biofeedback and M-mode US biofeedback in people with Pelvic Floor Disorders, run by Universidad de Murcia.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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 MARIA ELENA DEL BAÑO ALEDO, PhD (647193115, mbano@um.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the self efficacy expectations in performing pelvic floor exercises. (time frame: At baseline and after the intervention (1 week from baseline)). The study lists 2 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 1 Jun 2022.