Painful Bladder Syndrome Clinical Trial
Official title:
Prospective Observational Study That Evaluates Predictor Tests for the Success of Myofascial Pelvic Floor Muscles for the Treatment of PBS
Study aims to: (1) evaluate the role of morphological and physiological characteristics of
the pelvic floor, pain-related psychological and -psychophysical variables in prediction of
the success of myofascial physical therapy (MPT) for the treatment of painful bladder
syndrome Patients with clinical symptoms of PBS will undergo physical examination, sensory
testing in the genital area, perineal ultrasound examination for the evaluation of the
length of the levator muscles before MPT and following 10 consecutive sessions of MPT.
Improvement in clinical symptoms will be assessed and evaluated for correlations with
psychophysical examinations.
Background: Chronic pelvic pain syndrome (CPPS) is highly prevalent, yet its etiology and
the treatment approach are not clear. Painful bladder syndrome (PBS), a subtype of CPPS, is
commonly treated by Myofascial physical therapy (MPT), however its efficiency is limited to
portion of patients. The relative contribution of local factors such as pelvic anatomical
and physiological function compared with systemic pain- related psychological and
psychophysical parameters in the prediction of MPT outcome has not been illumined yet.
Hypothesis and aims: Assuming that MPT has mainly local effect its treatment success can be
predicted by local impairment of pelvic anatomical and physiological function assessed
pretreatment.
Study aims to: (1) evaluate the role of morphological and physiological characteristics of
the pelvic floor, pain-related psychological and -psychophysical variables in prediction of
MPT success, (2) to assess the effect of MPT on these parameters.
Methods: PBS patients will be evaluated for symptoms severity prior to MPT by: (1) pelvic
physical examination for identification of trigger points, (2) self-report of pelvic pain
intensity on visual analogue scale (VAS), (3) filling a questionnaire for urinary urgency
symptoms, (4) evaluation of morphological and physiological characters of pelvic muscles
floor by ultrasound and Doppler, respectively, (5) assessment of pain-related psychological
variables (depression, somatization and pain catastrophizing) by questionnaires, and (6)
psychophysical tests of experimental pain perception. Following 3 months treatment of MPT,
patients will be reevaluated for the same tests. Treatment success will be determined by 30%
reduction in pain and urinary urgency.
Expected results: Patients with shorter levator muscles and reduced blood flow in the pelvic
region will benefit from MPT compared to patients with augmented pain sensitivity and higher
depression, pain catastrophizing and somatization scores. MPT will elongate levator muscles
and increased blood flow to the pelvic region that will be associated with the improvement
in PBS symptoms.
Importance: The significance of the proposed study stems from its potential to extend
conceptualizing of mechanisms associated with PBS and its treatment success.
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Observational Model: Cohort, Time Perspective: Prospective
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