Clinical trial NCT02804048: Physiotherapy Intervention in Climacteric Women With Dyspareunia
Official title: Physiotherapy Intervention in Climacteric Women With Dyspareunia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspareunia
Keywords: Dyspareunia
Pelvic floor muscles
Women
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 42
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the effectiveness of physiotherapy techniques in pain improvement using visual analog scale pain
timeFrame: 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.
Secondary outcomes:
measure: To evaluate the quality of life
timeFrame: To evaluate the quality of life, using Cervantes Scale in climateric women in baseline and after four weeks of intervention
measure: To evaluate depression
timeFrame: To evaluate depression, using Beck Scale, in baseline and after four weeks of intervention
measure: To evaluate sexual function
timeFrame: To evaluate sexual function, using Female Sexual Function Index, in baseline and after four weeks of intervention
measure: To evaluate electrical activity of the pelvic floor muscles
timeFrame: To evaluate electrical activity of the pelvic floor muscles, using Electromyographic biofeedback , in baseline and after four weeks of intervention
measure: To evaluate the pelvic floor muscle function
timeFrame: To evaluate the pelvic floor muscle function, using PERFECT Scale in baseline and after four weeks of intervention
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Clinical Research Center of HCPA
state: RS
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Maria Celeste Wender, PhD
role: PRINCIPAL_INVESTIGATOR
References: