Identifying Predictors of Treatment Success in Painful Bladder Syndrome

• Conditions: Painful Bladder Syndrome
• Interventions: Device: quantitive sensory testing; Device: Ultrasound testing

• Registration Number: NCT01410461
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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.

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.

Study Timeline

• Status Verified: 2011-08
• Study First Submitted: 2011-08-04
• Study First Submitted QC: 2011-08-04
• Last Update Submitted: 2011-08-04
• Study First Posted: 2011-08-05
• Last Update Posted: 2011-08-05
• Study Start: 2011-09
• Primary Completion: 2013-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 35

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with painful bladder syndrome	quantitive sensory testing	Patients with diagnosis of PBS Will be offered to take part in the following study.
Patients with painful bladder syndrome	Ultrasound testing	Patients with diagnosis of PBS Will be offered to take part in the following study.

Primary Outcome Measures

Name	Time	Method
Reduction of pain level	3 months	Following MPT it is expected that patients PBS symptoms will be improved as will be evaluated by VAS.

Secondary Outcome Measures

Name	Time	Method
Elongation of levator ani muscles.	3 months	Following MPT treatment it is expected that the levator ani muscles will be elongated as will be measured by perineal US.

Trial Locations

Locations (1)

Zvolon Medical Center; 🇮🇱 Haifa, Israel