Clinical trial NCT00434343: Physical Therapy Trial for Pelvic Pain
Official title: A Pilot Feasibility Study of Physical Therapy for the Treatment of Urologic Pelvic Pain Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Cystitis
Painful Bladder Syndrome
Chronic Prostatitis
Chronic Pelvic Pain Syndrome
Keywords: Interstitial Cystitis
Painful Bladder Syndrome
Chronic Prostatitis
Chronic Pelvic Pain Syndrome
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: University of Pennsylvania
First posted: 2007-02-13
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a randomized trial of physical therapy for pelvic pain is feasible.

Detailed description: This is a pilot study wherein eligible participants will be randomly assigned to receive either myofascial tissue manipulation or global therapeutic massage. Those receiving myofascial tissue manipulation will have targeted internal and external connective tissue manipulation focusing on the muscles and connective tissues of the pelvic floor, hip girdle, and abdomen. Those receiving global therapeutic massage will have non-specific somatic treatment with full-body Western massage.

Eligibility criteria: Inclusion Criteria:

* female and male patients who have failed to respond to previous therapies for interstitial cystitis/painful bladder syndrome
* male patients who have failed to respond to previous therapies for chronic prostatitis/chronic pelvic pain syndrome

Exclusion Criteria:

* neurologic disorder affecting bladder
* bladder cancer, prostate cancer, or urethral cancer

Primary outcomes:
measure: Number consenting to join study out of eligible patients approached
timeFrame: 6 months
measure: Number of times therapists adhered to prescribed therapeutic protocol
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of adverse events reported by the participants
timeFrame: 12 weeks
measure: Global response assessment (GRA) Global response assessment
timeFrame: 12 weeks
measure: Tolerability of treatment measured by number of treatment sessions participants completed
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: National Institute of Diabetes & Digestive & Kidney Diseases/National Institutes of Health
name: John Kusek, PhD
role: STUDY_DIRECTOR
affiliation: National Institute of Diabetes & Digestive & Kidney Diseases/National Institutes of Health
name: Leroy Nyberg, PhD, MD
role: STUDY_DIRECTOR
References:
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.
citation: Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
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. 2013 Jan;189(1 Suppl):S75-85. doi: 10.1016/j.juro.2012.11.018.