Clinical trial NCT04334798: Pelvic Floor Consciousness in Women With Pelvic Floor Dysfunction
Official title: Effectiveness of Different Modalities of Motor Learning of Pelvic Floor Muscle Contraction in Women With Pelvic Floor Dysfunction: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Disorders
Keywords: Motor Learning
Pelvic Floor Muscles
Physiotherapy
Biofeedback
Consciousness
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 muscular properties of the pelvic floor muscles.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in life impact of pelvic floor dysfunction
timeFrame: 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.
measure: Change in symptoms and quality of life
timeFrame: 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:
measure: Change in pelvic floor muscle strength by manual scale
timeFrame: 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.
measure: Change in pelvic floor muscle strength by dynamometry
timeFrame: 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.
measure: Change in pelvic floor muscle passive tone
timeFrame: 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.
measure: Change in the displacement of the base of the bladder during voluntary contraction of the pelvic floor
timeFrame: 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.
Other outcomes:
Locations:
city: Alcalà de Henares
country: Spain
facility: Physiotherapy in women´s health research group. University of Alcalà
state: Madrid
city: Alcalá de Henares
country: Spain
facility: María Torres-Lacomba
state: Madrid
city: Alcalá de Henares
country: Spain
facility: University of Alcalá. FPSM research group. HUPA
state: Madrid
Study officials:
affiliation: University of Alcalá
name: María Torres-Lacomba, PhD
role: PRINCIPAL_INVESTIGATOR
References: