Pelvic Floor Consciousness in Women With Pelvic Floor Dysfunction (PFMCON)

University of Alcala

Status: Completed

Conditions: Pelvic Floor Disorders

Treatments: Other: Active exercises of the pelvic floor muscles & Biofeedback; Other: Active exercises of the pelvic floor muscles & Transabdominal US Biofeedback; Other: Active exercises of the pelvic floor muscles & Electrostimulation & Biofeedback; Other: Active exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US Biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT04334798

OE14/2020

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups

PFM&electro&BFB

Experimental group

Description:

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).

Treatment:

Other: Active exercises of the pelvic floor muscles & Electrostimulation & Biofeedback

PFM&BFB

Experimental group

Description:

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).

Treatment:

Other: Active exercises of the pelvic floor muscles & Biofeedback

PFM&electro&transabdominal US

Experimental group

Description:

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).

Treatment:

Other: Active exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US Biofeedback

PFM&transabdominal US

Experimental group

Description:

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).

Treatment:

Other: Active exercises of the pelvic floor muscles & Transabdominal US Biofeedback