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

Rambam Health Care Campus

Status: Unknown

Conditions: Painful Bladder Syndrome

Treatments: Device: Ultrasound testing; Device: quantitive sensory testing

Study type: Observational

Funder types: Other

Identifiers

NCT01410461

RMV-0232-10

RMB-0232-10 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

35 participants in 1 patient group

Patients with painful bladder syndrome

Description:

Patients with diagnosis of PBS Will be offered to take part in the following study.

Treatment:

Device: quantitive sensory testing

Device: Ultrasound testing