Identifying Predictors of Treatment Success in Painful Bladder Syndrome

NCT01410461 | Unknown

• 2 other identifiers: RMV-0232-10RMB-0232-10
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Painful Bladder Syndrome

Keywords

painful bladder; physical therapy; levator ani

Outcome Measures

Primary Outcomes (1)

• Reduction of pain level

  Following MPT it is expected that patients PBS symptoms will be improved as will be evaluated by VAS.

  3 months

Secondary Outcomes (1)

• Elongation of levator ani muscles.

  3 months

Study Arms (1)

Patients with painful bladder syndrome

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

Device: quantitive sensory testing; Device: Ultrasound testing

Interventions

quantitive sensory testing DEVICE

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

Also known as: TSA, Medoc Ramat Yishay, Israel

Patients with painful bladder syndrome

Ultrasound testing DEVICE

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.

Also known as: Voluson 730 Expert; GE Healthcare

Patients with painful bladder syndrome

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with clinical diagnosis of painful bladder syndrome

You may qualify if:

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

You may not qualify if:

• history of pelvic cancer or radiation
• pelvic or abdominal surgery within 3 months
• urinary tract infection within the last month
• diagnosis of fibromyalgia or irritable bowel disease
• diagnosis of neurologic disorder; diabetes; pregnancy;
• pelvic pain and/ or urgency symptoms presented only during menses.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Zvolon Medical Center

Haifa, 34987, Israel

Location

Related Publications (2)

• 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.

  PMID: 19837420 BACKGROUND

• 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.

  PMID: 19535099 BACKGROUND

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Lior Lowenstein, MD

  Rambam Health Care Campus

  STUDY CHAIR

Central Study Contacts

Lior Lowenstein, MD

CONTACT

97248542612; lowensteinmd@gmail.com

Dalia Kesner, MD

CONTACT

97248542612; daliake@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2011
• First Posted: August 5, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 5, 2011

Record last verified: 2011-08

Locations

IL (1)