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Completed

NCT Number: NCT04334798

Pelvic Floor Consciousness in Women With Pelvic Floor Dysfunction

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.

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Key information

Conditions

Pelvic Floor Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Physiotherapy in women´s health research group. University of Alcalà, Alcalà de Henares, Madrid, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active exercises of the pelvic floor muscles & Electrostimulation & Biofeedback

Other

See information included in arm/group descriptions.

Active exercises of the pelvic floor muscles & Biofeedback

Other

See information included in arm/group descriptions.

Active exercises of the pelvic floor muscles & Transabdominal US Biofeedback

Other

See information included in arm/group descriptions.

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

Other

See information included in arm/group descriptions.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    It will be measured by dynamometry (measured in GRAMS).

  3. 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.

    It will be measured by dynamometry (measured in GRAMS).

  4. 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.

    It will be measured by Ultrasound

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

Effectiveness of Different Modalities of Motor Learning of Pelvic Floor Muscle Contraction in Women With Pelvic Floor Dysfunction: Randomized Controlled Trial

Acronym: PFMCON

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Apr 6, 2020
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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