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Completed

NCT Number: NCT02804048

Physiotherapy Intervention in Climacteric Women With Dyspareunia

Aim: To evaluate the effectiveness of physical therapy intervention techniques in the improvement of dyspareunia in climacteric women.

Study design: This is a randomized controlled trial.

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Key information

Conditions

Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center of HCPA

Porto Alegre, Rio Grande do Sul, 900035-903, Brazil

About this study

Search location: Menopause and Sexuality Clinic of the department of obstetrics and Gynecology and Clinical Research Center, Hospital de Clínicas de Porto Alegre (HCPA).

Patients or participants: The recruited patients may not be vaginal atrophy (cytology-hormone test) and must provide the diagnosis of dyspareunia for more than six months being confirmed by one of the investigators through the pain score above grade 3 (visual analog pain scale) visual inspection, palpation and a questionnaire about the duration and location of pain.

Intervention and measures: consist of evaluation of the pelvic floor muscles (Oxford Scale and Perfect), myoelectric assessment (Electromyography), quality of life (Cervantes Scale), sexual function (FSFI), level of depression (Beck Scale) and pain (visual analog pain scale) before and after physical therapy intervention.

Expected results: To estimate the effectiveness of pelvic floor training techniques with physical therapy in women with dyspareunia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • dyspareunia complaint for at least six months
  • visual analog scale of pain above 3
  • trophic vagina

Exclusion criteria

  • vaginal atrophy
  • neurological disorders
  • lack of cognition and understanding
  • urinary tract infection and / or genital infections
  • prolapse grade 2 and 3
  • severe systemic disease
  • performing physical therapy

Treatment and study plan

superficial heat pelvic floor muscle

Other

Superficial heat application in the pelvic floor muscle

superficial heat low back

Other

Superficial heat application in the low back

Pelvic Floor Muscle training

Other

Pelvic floor muscle training exercises

Manual therapy in iliopsoas, diaphragm and piriformis

Other

Manual therapy in iliopsoas, diaphragm and piriformis for 10 minutes

Intra Vaginal Manual therapy

Other

Intra Vaginal Manual therapy in the pelvic floor muscles

Electromyographic biofeedback

Other

Electromyographic biofeedback in the pelvic floor muscles

Primary outcomes

  1. To evaluate the effectiveness of physiotherapy techniques in pain improvement using visual analog scale pain

    Time frame: Seven meetings, twice a week, in which the first is the initial assessment and the seventh is the final evaluation totaling a maximum of one month treatment for each patient.

    To evaluate the effectiveness of physiotherapy techniques using the analog pain scale.

Secondary outcomes

  1. To evaluate the quality of life

    Time frame: To evaluate the quality of life, using Cervantes Scale in climateric women in baseline and after four weeks of intervention

  2. To evaluate depression

    Time frame: To evaluate depression, using Beck Scale, in baseline and after four weeks of intervention

  3. To evaluate sexual function

    Time frame: To evaluate sexual function, using Female Sexual Function Index, in baseline and after four weeks of intervention

  4. To evaluate electrical activity of the pelvic floor muscles

    Time frame: To evaluate electrical activity of the pelvic floor muscles, using Electromyographic biofeedback , in baseline and after four weeks of intervention

  5. To evaluate the pelvic floor muscle function

    Time frame: To evaluate the pelvic floor muscle function, using PERFECT Scale in baseline and after four weeks of intervention

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

Physiotherapy Intervention in Climacteric Women With Dyspareunia: A Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2016
Registry last updated
Oct 5, 2016

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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