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Identifying Predictors of Treatment Success in Painful Bladder Syndrome (PBS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01410461
First received: August 4, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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 Intervention
Painful Bladder Syndrome
Device: quantitive sensory testing
Device: Ultrasound testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study That Evaluates Predictor Tests for the Success of Myofascial Pelvic Floor Muscles for the Treatment of PBS

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Reduction of pain level [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Following MPT it is expected that patients PBS symptoms will be improved as will be evaluated by VAS.


Secondary Outcome Measures:
  • Elongation of levator ani muscles. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Following MPT treatment it is expected that the levator ani muscles will be elongated as will be measured by perineal US.


Estimated Enrollment: 35
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with clinical diagnosis of painful bladder syndrome

Criteria

Inclusion Criteria:

  1. age > 18 years old
  2. urinary frequency of at least 10 per 24 hr including one nighttime voiding
  3. complaints of bladder pain that has been present for at least 3 months
  4. pain intensity rated at least four on a VAS from 0 ''no pain at all'' to 10 ''worst imaginable pain'' during the previous month
  5. pelvic digital exam reveals at least three different TrPs in the levator ani muscles that are verbally confirmed.

Exclusion criteria:

  1. history of pelvic cancer or radiation
  2. pelvic or abdominal surgery within 3 months
  3. urinary tract infection within the last month
  4. diagnosis of fibromyalgia or irritable bowel disease
  5. diagnosis of neurologic disorder; diabetes; pregnancy;
  6. pelvic pain and/ or urgency symptoms presented only during menses.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410461

Contacts
Contact: Lior Lowenstein, MD 97248542612 lowensteinmd@gmail.com
Contact: Dalia Kesner, MD 97248542612 daliake@clalit.org.il

Locations
Israel
Zvolon Medical Center Not yet recruiting
Haifa, Israel, 34987
Contact: Lior Lowenstein, MD    97248542612    lowensteinmd@gmail.com   
Contact: Dalia Kesner, MD    97248542382    daliake@clalit.org.il   
Principal Investigator: Dalia Kesner, MD         
Sub-Investigator: Lior Lowenstein, MD         
Sub-Investigator: Eyal Goldshmit, MD         
Sub-Investigator: Talma Rosen, RN         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Study Chair: Lior Lowenstein, MD Rambam Health Care Campus
  More Information

Publications:
Responsible Party: Dalia Kesner, MD, Zvolon Medical Center
ClinicalTrials.gov Identifier: NCT01410461     History of Changes
Other Study ID Numbers: RMV-0232-10, RMB-0232-10
Study First Received: August 4, 2011
Last Updated: August 4, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Rambam Health Care Campus:
painful bladder
physical therapy
levator ani

Additional relevant MeSH terms:
Pain
Syndrome
Cystitis, Interstitial
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Disease
Pathologic Processes
Cystitis
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014