Clinical Trial: Physiotherapy Intervention in Climacteric Women With Dyspareunia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Hospital de Clinicas de Porto Alegre

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • To evaluate depression [ Time Frame: To evaluate depression, using Beck Scale, in baseline and after four weeks of intervention ]
  • To evaluate sexual function [ Time Frame: To evaluate sexual function, using Female Sexual Function Index, in baseline and after four weeks of intervention ]
  • 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 ]
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Hospital de Clinicas de Porto Alegre

Dates:
Date Received: February 12, 2016
Date Started: December 2012
Date Completion:
Last Updated: October 4, 2016
Last Verified: October 2016