Identifying Predictors of Treatment Success in Painful Bladder Syndrome (PBS)
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|ClinicalTrials.gov Identifier: NCT01410461|
Recruitment Status : Unknown
Verified August 2011 by Rambam Health Care Campus.
Recruitment status was: Not yet recruiting
First Posted : August 5, 2011
Last Update Posted : August 5, 2011
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.
|Condition or disease||Intervention/treatment|
|Painful Bladder Syndrome||Device: quantitive sensory testing Device: Ultrasound testing|
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.
|Study Type :||Observational|
|Estimated Enrollment :||35 participants|
|Official Title:||Prospective Observational Study That Evaluates Predictor Tests for the Success of Myofascial Pelvic Floor Muscles for the Treatment of PBS|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2013|
Patients with painful bladder syndrome
Patients with diagnosis of PBS Will be offered to take part in the following study.
Device: quantitive sensory testing
Mechanical pain threshold: Threshold will be assessed, by using the von Frey filaments. The lowest gram weight capable of inducing pain in two of three trials will be considered as a pain threshold Heat pain threshold (HPT): HPT will be measured using thermal sensory analyzer
Other Name: TSA, Medoc Ramat Yishay, Israel
Device: Ultrasound testing
Morphological measures of the pelvic muscles: Using a 3D 4-8MHz abdominal probe ultrasound testing will be performed. The following parameters will be measured: (1) anteroposterior hiatal diameter; (2) lateral hiatal diameter; (3) levator ani thickness and length at 3 o'clock and 9 o'clock; (4) length of the obturator (5) length of the pubococcygeus muscle; (6) obturator thickness.
Other Name: Voluson 730 Expert; GE Healthcare
- Reduction of pain level [ Time Frame: 3 months ]Following MPT it is expected that patients PBS symptoms will be improved as will be evaluated by VAS.
- Elongation of levator ani muscles. [ Time Frame: 3 months ]Following MPT treatment it is expected that the levator ani muscles will be elongated as will be measured by perineal US.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410461
|Contact: Lior Lowenstein, MDfirstname.lastname@example.org|
|Contact: Dalia Kesner, MDemail@example.com|
|Zvolon Medical Center||Not yet recruiting|
|Haifa, Israel, 34987|
|Contact: Lior Lowenstein, MD 97248542612 firstname.lastname@example.org|
|Contact: Dalia Kesner, MD 97248542382 email@example.com|
|Principal Investigator: Dalia Kesner, MD|
|Sub-Investigator: Lior Lowenstein, MD|
|Sub-Investigator: Eyal Goldshmit, MD|
|Sub-Investigator: Talma Rosen, RN|
|Study Chair:||Lior Lowenstein, MD||Rambam Health Care Campus|