Clinical trial NCT01410461: Identifying Predictors of Treatment Success in Painful Bladder Syndrome
Official title: Prospective Observational Study That Evaluates Predictor Tests for the Success of Myofascial Pelvic Floor Muscles for the Treatment of PBS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Painful Bladder Syndrome
Keywords: painful bladder
physical therapy
levator ani
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-08-05
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinical diagnosis of painful bladder syndrome

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.

Eligibility 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.

Primary outcomes:
measure: Reduction of pain level
timeFrame: 3 months
Secondary outcomes:
measure: Elongation of levator ani muscles.
timeFrame: 3 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Zvolon Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Lior Lowenstein, MD
role: STUDY_CHAIR
References:
citation: Anderson RU, Sawyer T, Wise D, Morey A, Nathanson BH. Painful myofascial trigger points and pain sites in men with chronic prostatitis/chronic pelvic pain syndrome. J Urol. 2009 Dec;182(6):2753-8. doi: 10.1016/j.juro.2009.08.033. Epub 2009 Oct 17.
citation: FitzGerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, Kotarinos R, Fraser L, Cosby A, Fortman C, Neville C, Badillo S, Odabachian L, Sanfield A, O'Dougherty B, Halle-Podell R, Cen L, Chuai S, Landis JR, Mickelberg K, Barrell T, Kusek JW, Nyberg LM; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2009 Aug;182(2):570-80. doi: 10.1016/j.juro.2009.04.022. Epub 2009 Jun 17.