Physical Therapy in Women With Interstitial Cystitis

NCT00733603 | Completed DMC

• 2 other identifiers: ICCRN RCT3 - PTU01DK065209
• Study Type: interventional
• Target: 81
• Locations: 2 countries
• Sites: 11

Brief Summary

There are many different treatments that doctors recommend for patients with IC/PBS. Only a few research studies have been done to evaluate treatments given to patients. Treatment choices can be of two types: drug therapy and non-drug therapy. The two treatments used in this study will be of the non-drug therapy type. One of the treatments being used in this study is called Myofascial Tissue Manipulation. This is a kind of physical therapy that is designed to work on specific muscles and tissue layers in a particular part of the body. In this study, this treatment will focus on the areas around the pelvis and the pelvic floor. The treatment will involve the physical therapist's use of hands and fingers to target specific muscles and tissues located within your pelvis, rectum, and/or vagina (the pelvic floor) as well as muscles and layers of tissue in your abdomen and legs. The other treatment being used in this study is Global Therapeutic Massage. This treatment involves the physical therapist's use of classic Western body massage techniques on the muscles of your arms, legs, hands, neck, shoulders, back, stomach, buttocks, and feet to create an overall feeling of well being. The purpose of this research study is to find out if Pelvic Physical Therapy is safe and effective on treating symptoms in women with interstitial cystitis as compared to a full body therapeutic massage. This study will also measure the lasting effects of the treatment up to 3 months after your last study treatment.

Conditions

Interstitial Cystitis; Painful Bladder Syndrome

Keywords

Interstitial Cystitis; IC; Painful Bladder Syndrome; PBS; Bladder Pain; Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• Proportion of responders moderately or markedly improved on a 7-point global response assessment (GRA) scale

  The GRA asked: "As compared to when you started the current study, how would you rate your overall symptoms now?" the 7 response options were markedly worse, moderately worse, slightly worse, the same, slightly improved, moderately improved and markedly improved

  12 Weeks

Secondary Outcomes (3)

• Change in pain score

  Baseline and 12 weeks

• Change in urgency score

  Baseline and 12 weeks

• Change in frequency score

  Baseline and 12 weeks

Study Arms (2)

Global Therapeutic Massage (GTM)

SHAM COMPARATOR

Non-specific somatic treatment with full-body Western massage.

Other: Global Therapeutic Massages (GTM)

Myofascial Tissue Manipulation (MTM)

ACTIVE COMPARATOR

Targeted internal and external Connective Tissue Manipulation focusing on the muscles and connective tissues of the pelvic floor, hip girdle, and abdomen.

Other: Myofascial Tissue Manipulation (MTM)

Interventions

Global Therapeutic Massages (GTM) OTHER

Non-specific somatic treatment with full-body Western massage.

Global Therapeutic Massage (GTM)

Myofascial Tissue Manipulation (MTM) OTHER

Targeted internal and external Connective Tissue Manipulation focusing on the muscles and connective tissues of the pelvic floor, hip girdle, and abdomen.

Myofascial Tissue Manipulation (MTM)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has signed and dated the appropriate Informed Consent document.
• Female participant is ≥ 18 years of age.
• Currently using an approved method of birth control, or surgically sterile, or of non-child bearing age with no menstrual period for the past year.
• Participant has a clinical diagnosis of IC/PBS in the opinion of the investigator.
• Participant with IC/PBS has reported a bladder pain/discomfort score of 3 or greater on a 0-10 Likert scale over the previous four weeks. This bladder pain/discomfort criterion must be met at each of the two baseline screening visits as reported by the participant.
• Participant with IC/PBS has reported a symptom score of abnormal urinary frequency of 3 or greater on a 0-10 Likert scale over the previous four weeks. This frequency criterion must be met at each of the two baseline screening visits, as reported by the participant.
• Participant has had symptoms of discomfort or pain in the pelvic region for at least a three (3) month period within the last six (6) months.
• Current symptoms have been present for less than 3 years. If similar symptoms were present in the past, they must have been completely resolved for at least one year prior to onset of current symptoms.
• Participant has previously undergone at least one course of therapy (other than physical therapy) for her symptoms.
• Presence of tenderness/pain to palpation found by the physician in one of the pelvic floor musculature domains during the first baseline screening visit physical examination which are confirmed by the physical therapist at screening visit 2. Presence of tenderness/pain is defined as a mild, moderate or severe finding by the physician at visit 1 and physical therapist at visit 2. The pelvic floor musculature domains are defined as: anterior or posterior levator muscles, obturator internus muscles and urogenital diaphragm (bulbospongiosus, superficial transverse perinei, ischiocavernosus, central tendon/perineal body). The assessment of tenderness/pain at Visits 1 and 2 do not need to be identical in severity or location in order for the participant to be eligible.

You may not qualify if:

• Participant has relevant, painful scars on lower abdominal wall that, in the opinion of the study physician or physical therapist, is unlikely to respond to physical therapy without adjuvant therapy such as injection /needling.
• Participant is unable to tolerate insertion of one or two vaginal examining fingers (e.g. vulvar allodynia), or one rectal examining finger.
• Participant has relevant neurologic disorder that affects bladder and/or neuromuscular function in the opinion of the investigator.
• Participant has active urethral or ureteral calculi, urethral diverticulum.
• Participant has a history of pelvic radiation therapy, tuberculous cystitis, bladder cancer, carcinoma in situ, or urethral cancer.
• Participant has/reports any severe debilitating or urgent concurrent medical condition.
• Participant has a potentially significant pelvic pathology or abnormalities on examination or prior imaging, including prolapse beyond the hymenal ring, pelvic mass, etc. that could cause or contribute to the clinical symptoms or require treatment.
• Participant is unlikely to be compliant due to unmanaged medical or psychological condition, including neurological, psychological or speech /language problems that will interfere with her ability to complete the study.
• Participant has an imminent change in residence or other social factors that could compromise compliance with the protocol.
• Pregnancy or refusal of medically approved/reliable birth control in women of child-bearing potential.
• Participant has pain, frequency, urgency symptoms present only during menses.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• University of Pennsylvania: collaborator

Study Sites (11)

Univeristy of California San Diego

San Diego, California, 92093, United States

Location

Stanford University Medical center

Stanford, California, 94305, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Iowa Hospitals and Clinic

Iowa City, Iowa, 52242, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Queen's University

Kingston, Ontario, K7L2V7, Canada

Location

Related Publications (2)

• FitzGerald MP, Payne CK, Lukacz ES, Yang CC, Peters KM, Chai TC, Nickel JC, Hanno PM, Kreder KJ, Burks DA, Mayer R, Kotarinos R, Fortman C, Allen TM, Fraser L, Mason-Cover M, Furey C, Odabachian L, Sanfield A, Chu J, Huestis K, Tata GE, Dugan N, Sheth H, Bewyer K, Anaeme A, Newton K, Featherstone W, Halle-Podell R, Cen L, Landis JR, Propert KJ, Foster HE Jr, Kusek JW, Nyberg LM; Interstitial Cystitis Collaborative Research Network. Randomized multicenter clinical trial of myofascial physical therapy in women with interstitial cystitis/painful bladder syndrome and pelvic floor tenderness. J Urol. 2012 Jun;187(6):2113-8. doi: 10.1016/j.juro.2012.01.123. Epub 2012 Apr 12.

  PMID: 22503015 RESULT

• 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.

  PMID: 32734597 DERIVED

MeSH Terms

Conditions

Cystitis, Interstitial; Pelvic Pain

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• LeRoy M Nyberg, MD, PhD

  NIDDK/NIH

  STUDY DIRECTOR

• Mary P Fitzgerald, MD

  Loyola University

  STUDY CHAIR

• Richard Landis, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Robert Mayer, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Emily Lukacz, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Kenneth Peters, MD

  William Beaumont Hospital, Royal Oak, MI

  PRINCIPAL INVESTIGATOR

• Toby Chai, MD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

• Christopher Payne, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Claire Yang, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Phillip Hanno, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Karl Kreder, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• David Burks, MD

  Henry Ford Hospital, Detroit

  PRINCIPAL INVESTIGATOR

• Curtis Nickel, MD

  Queen's University, Ontario, Canada

  PRINCIPAL INVESTIGATOR

• Harris Foster, MD

  Yale University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 13, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 22, 2021

Record last verified: 2021-03

Locations

US (10); CA (1)