Pelvic Floor DisordersPFMCONNCT04334798
Pelvic Floor Consciousness in Women With Pelvic Floor Dysfunction
A study testing Active exercises of the pelvic floor muscles & Electrostimulation & Biofeedback, Active exercises of the pelvic floor muscles & Biofeedback and Active exercises of the pelvic floor muscles & Transabdominal US Biofeedback in people with Pelvic Floor Disorders, run by University of Alcala at 3 sites in Spain.
Trial summary
The purpose of the study is to compare the efficacy of different modalities of motor learning of pelvic floor muscle contraction in women with pelvic floor dysfunctions, considering the efficacy of the treatment as improving the specific quality of life related to pelvic floor dysfunctions and improvement of the… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Active exercises of the pelvic floor muscles & Electrostimulation & Biofeedback, Active exercises of the pelvic floor muscles & Biofeedback and Active exercises of the pelvic floor muscles & Transabdominal US Biofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesSpain
- Study dates
- 10 Jan 2019to 31 Dec 2023
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women diagnosed with pelvic floor dysfunction by their doctor.
- Women who are unable to voluntarily contract the pelvic floor muscles, quantified by the Modified Oxford Score by a score less than or equal to 2.
Who cannot join
- Women who are pregnant or women who have had a vaginal or caesarean birth in the past six months.
- Women whose PFD is severe, and the first indication is surgical (POP-Q grade III-IV prolapses).
- Women with pain in the pelvic-perineal region of 3 cm in the visual analog scale, where a score of 0 cm means no pain, and a score of 10 cm, the maximum pain that the participant can imagine.
- Women who have received pelvic floor physiotherapy treatment in the last 12 months.
- Women with any pathology that may affect the treatment (neurological, gynecological or urological), or with recurrent urinary infection or hematuria.
- Women with cognitive limitations to understand the information, answer the questionnaires, consent and / or participate in the study.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
María Torres-Lacomba
Alcalá de Henares, Madrid, 28005
University of Alcalá. FPSM research group. HUPA
Alcalá de Henares, Madrid, 28805
Physiotherapy in women´s health research group. University of Alcalà
Alcalà de Henares, Madrid, 28871
About this study
Official title: Effectiveness of Different Modalities of Motor Learning of Pelvic Floor Muscle Contraction in Women With Pelvic Floor Dysfunction: Randomized Controlled Trial
The purpose of the study is to compare the efficacy of different modalities of motor learning of pelvic floor muscle contraction in women with pelvic floor dysfunctions, considering the efficacy of the treatment as improving the specific quality of life related to pelvic floor dysfunctions and improvement of the muscular properties of the pelvic floor muscles.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Active exercises of the pelvic floor muscles & Electrostimulation & Biofeedback, Active exercises of the pelvic floor muscles & Biofeedback, Active exercises of the pelvic floor muscles & Transabdominal US Biofeedback, Active exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US Biofeedback
- Keywords
- Motor Learning, Pelvic Floor Muscles, Physiotherapy, Biofeedback, Consciousness
- 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.
Active exercises of the pelvic floor muscles & Electrostimulation & BiofeedbackOther
See information included in arm/group descriptions.
Active exercises of the pelvic floor muscles & BiofeedbackOther
See information included in arm/group descriptions.
Active exercises of the pelvic floor muscles & Transabdominal US BiofeedbackOther
See information included in arm/group descriptions.
Active exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US BiofeedbackOther
See information included in arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| PFM&electro&BFB | Experimental | An educational program (anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity; knack) will be implemented, and active exercises of the pelvic floor muscles (PFM) will be performed using intravaginal palpation and electrostimulation, together with biofeedback (BFB). Receives: Other: Active exercises of the pelvic floor muscles & Electrostimulation & Biofeedback |
| PFM&BFB | Experimental | An educational program (anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity; knack) will be implemented, and active exercises of the PFM will be performed using intravaginal palpation together with biofeedback (BFB). Receives: Other: Active exercises of the pelvic floor muscles & Biofeedback |
| PFM&electro&transabdominal US | Experimental | An educational program (anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity; knack) will be implemented, and active exercises of the PFM will be performed using intravaginal palpation and electrostimulation, together with transabdominal ultrasound biofeedback (BFB). Receives: Other: Active exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US Biofeedback |
| PFM&transabdominal US | Experimental | An educational program (anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity; knack) will be implemented, and active exercises of the PFM will be performed using intravaginal palpation together with transabdominal ultrasound biofeedback (BFB). Receives: Other: Active exercises of the pelvic floor muscles & Transabdominal US Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in life impact of pelvic floor dysfunction
It will be assessed by the Pelvic Floor Impact Questionnaire-7 (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.
Change in symptoms and quality of life
It will be assessed by the Pelvic Floor Distress Inventory-20 (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 (POP) Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions collecting data about Urinary Incontinence (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 pelvic floor muscle strength by manual scale
It will be measured by Modified Oxford Scale to rate pelvic floor muscle contraction on a scale of 0-5: 0 = no contraction; 1 = minor muscle; 'flicker'; 2 = weak muscle; contraction; 3 = moderate muscle contraction; 4 = good muscle contraction and 5 = strong muscle contraction.
Measured: 5 assessments to evaluate change from 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 by dynamometry
It will be measured by dynamometry (measured in GRAMS).
Measured: 5 assessments to evaluate change from baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Change in pelvic floor muscle passive tone
It will be measured by dynamometry (measured in GRAMS).
Measured: 5 assessments to evaluate change from baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Change in the displacement of the base of the bladder during voluntary contraction of the pelvic floor
It will be measured by Ultrasound
Measured: 5 assessments to evaluate change from 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 posted6 Apr 2020
- Study start10 Jan 2019
- Primary completion20 Oct 2021
- Study completion31 Dec 2023
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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 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
- Investigators
- María Torres-Lacomba, PhD, Principal investigator, University of Alcalá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334798
- Sponsor's protocol ID
- OE14/2020
- Acronym
- PFMCON
- Status last verified
- Jan 2024
- First submitted
- 2 Apr 2020
- Last updated
- 22 Jan 2024
- 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 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Modalities of Motor Learning of Pelvic Floor Muscle Contraction in Women With Pelvic Floor Dysfunction: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04334798
- Acronym / sponsor ID
- PFMCON / OE14/2020
- Conditions
- Pelvic Floor Disorders
- Keywords
- Motor Learning, Pelvic Floor Muscles, Physiotherapy, Biofeedback, Consciousness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Apr 2020 (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.
The purpose of the study is to compare the efficacy of different modalities of motor learning of pelvic floor muscle contraction in women with pelvic floor dysfunctions, considering the efficacy of the treatment as improving the specific quality of life related to pelvic floor dysfunctions and improvement of the muscular properties of the pelvic floor muscles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PFM&electro&BFB | Experimental | Other: Active exercises of the pelvic floor muscles & Electrostimulation & BiofeedbackAn educational program (anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity; knack) will be implemented, and active exercises of the pelvic floor muscles (PFM) will be performed using intravaginal palpation and electrostimulation, together with biofeedback (BFB). |
| PFM&BFB | Experimental | Other: Active exercises of the pelvic floor muscles & BiofeedbackAn educational program (anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity; knack) will be implemented, and active exercises of the PFM will be performed using intravaginal palpation together with biofeedback (BFB). |
| PFM&electro&transabdominal US | Experimental | Other: Active exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US BiofeedbackAn educational program (anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity; knack) will be implemented, and active exercises of the PFM will be performed using intravaginal palpation and electrostimulation, together with transabdominal ultrasound biofeedback (BFB). |
| PFM&transabdominal US | Experimental | Other: Active exercises of the pelvic floor muscles & Transabdominal US BiofeedbackAn educational program (anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity; knack) will be implemented, and active exercises of the PFM will be performed using intravaginal palpation together with transabdominal ultrasound biofeedback (BFB). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women diagnosed with pelvic floor dysfunction by their doctor.
- Women who are unable to voluntarily contract the pelvic floor muscles, quantified by the Modified Oxford Score by a score less than or equal to 2.
Key exclusion criteria (6 listed)
- Women who are pregnant or women who have had a vaginal or caesarean birth in the past six months.
- Women whose PFD is severe, and the first indication is surgical (POP-Q grade III-IV prolapses).
- Women with pain in the pelvic-perineal region of 3 cm in the visual analog scale, where a score of 0 cm means no pain, and a score of 10 cm, the maximum pain that the participant can imagine.
- Women who have received pelvic floor physiotherapy treatment in the last 12 months.
- Women with any pathology that may affect the treatment (neurological, gynecological or urological), or with recurrent urinary infection or hematuria.
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 |
|---|---|---|
| Active exercises of the pelvic floor muscles & Electrostimulation & BiofeedbackSee information included in arm/group descriptions. | Other | PFM&electro&BFB |
| Active exercises of the pelvic floor muscles & BiofeedbackSee information included in arm/group descriptions. | Other | PFM&BFB |
| Active exercises of the pelvic floor muscles & Transabdominal US BiofeedbackSee information included in arm/group descriptions. | Other | PFM&transabdominal US |
| Active exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US BiofeedbackSee information included in arm/group descriptions. | Other | PFM&electro&transabdominal US |
Primary outcome
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.
It will be assessed by the Pelvic Floor Impact Questionnaire-7 (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).
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 the Pelvic Floor Distress Inventory-20 (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 (POP) Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions collecting data about Urinary Incontinence (UI), POP and colorectal and anal symptoms.
4 secondary outcomes
Change in pelvic floor muscle strength by manual scale
Time frame: 5 assessments to evaluate change from 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 by dynamometry
Time frame: 5 assessments to evaluate change from baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Change in pelvic floor muscle passive tone
Time frame: 5 assessments to evaluate change from baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Change in the displacement of the base of the bladder during voluntary contraction of the pelvic floor
Time frame: 5 assessments to evaluate change from 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 22 Jan 2024.
- 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.
María Torres-Lacomba, PhD principal investigator
University of Alcalá
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active exercises of the pelvic floor muscles & Electrostimulation & Biofeedback, Active exercises of the pelvic floor muscles & Biofeedback and Active exercises of the pelvic floor muscles & Transabdominal US Biofeedback in people with Pelvic Floor Disorders, run by University of Alcala at 3 sites 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 2 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 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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.). 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 22 Jan 2024.