Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-25 @ 4:47 PM
Study NCT ID:
NCT00733603
Status:
COMPLETED
Last Update Posted:
2021-03-22
First Post:
2008-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physical Therapy in Women With Interstitial Cystitis
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Organization:
Study Overview
Official Title:
A Single-Blinded Randomized Multi-Center Trial to Evaluate the Efficacy and Durability of Myofascial Tissue Manipulation in Women With Interstitial Cystitis/Painful Bladder Syndrome
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IC03
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.
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.
Detailed Description:
The Urologic Pelvic Pain Syndromes (UPPS) are characterized by pelvic pain with concurrent urinary symptoms. Broadly, the UPPS comprise Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) in men and women, and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) in men, although the focus of this protocol is exclusively women with IC/PBS.
Interstitial Cystitis (IC) is a debilitating bladder disorder characterized by urinary urgency, frequency, and pain. The presentation of symptoms can be quite variable among patients, suggesting that IC is a multi-factorial syndrome with several proposed etiologies, some of which may be interrelated.1 Painful Bladder Syndrome (PBS), as defined by the International Continence Society, is "the complaint of suprapubic pain related to bladder filling, accompanied by other symptoms, such as increased daytime and night-time frequency, in the absence of proven urinary infection or other obvious pathology. 2" PBS is a clinical description of disease based on the patient's symptoms and does not depend on urodynamic or cystoscopic findings. These symptoms may be related to interstitial cystitis, although diagnostic criteria are still lacking for this entity, and the relationship between PBS and interstitial cystitis is not clear. For clarity and compliance with current nomenclature, this protocol will use the term IC/PBS.
As with many chronic pain disorders, IC/PBS is poorly understood, poorly characterized, and treatment is mostly empirical and unsatisfactory. Several proposed etiologic theories include (1) increased bladder epithelial permeability, (2) activation of bladder mast cells, (3) allergic or autoimmune processes, (4) toxic substance(s) in the urine, (5) occult infection, (6) neuropathic changes, and (7) neurogenic inflammation. However, none of these mechanisms have been conclusively shown to be responsible for IC/PBS. Estimates of prevalence of the syndromes vary widely. In 1990 interstitial cystitis (IC) was thought to affect as many as 500,000 U.S. citizens, with 25% of patients under age 25.3 More recently however, using expanded definitions of PBS now exceed 10 million.4 Quality of life with IC/PBS can be worse than end stage renal disease.5 The recent pilot study of manual physical therapies for Urologic Pelvic Pain demonstrated feasibility of recruitment, and promising benefit of myofascial tissue manipulation (MTM) (ref manuscript#1). In that pilot study, 47 participants were recruited to six centers with prior expertise in MTM. Of the 47 participants, 24 were females with IC/PBS, and 23 were males -- 2 with IC/PBS and 21 with CP/CPPS. Motivated by the promising findings in that pilot study, this protocol aims to investigate whether those initial results are generalizable in an expanded phase 3 clinical trial, in which we include other therapists from other centers. However, due to the gender-specific findings of the pilot study, and the limited resources available, this protocol is focused on replicating the initial pilot study exclusively in women with IC/PBS.
Although the pain of IC/PBS is poorly understood, almost all clinicians agree that there is almost always some chronic tension and tenderness of the pelvic floor musculature present in UPPS patients,8-10 and it is possible that these myofascial abnormalities contribute significantly to the pain of IC/PBS. For example, Hetrick et al11 compared the surface EMG signals from men with CPPS to those from men without chronic pain, and found that there was greater EMG instability in men with CPPS, along with increased baseline tonicity, and instability with lowered voluntary endurance contraction amplitude.
Whether these musculoskeletal abnormalities of the abdominal wall and pelvic floor musculature found in IC/PBS sufferers represent primary or secondary phenomena remains unknown. It is possible that pelvic visceral pain leads to chronic contraction of regional skeletal musculature, leading to overuse injury and pain. It is also possible that primary pelvic myofascial problems lead to painful and weakened pelvic floor musculature, which also functions poorly to inhibit the urgency associated with bladder filling.
Our prior study of manual physical therapy suggested benefit of MTM over GTM. Translation of those office practices into the research setting was apparently successful in centers that participated in the first trial. We propose to expand the number of treating therapists to include 11 study centers, in order to determine whether the results of the first trial can be generalized, at least in the research setting. However, due to the gender-specific findings, this expanded replication study will focus exclusively on women with IC/PBS.
Interstitial Cystitis (IC) is a debilitating bladder disorder characterized by urinary urgency, frequency, and pain. The presentation of symptoms can be quite variable among patients, suggesting that IC is a multi-factorial syndrome with several proposed etiologies, some of which may be interrelated.1 Painful Bladder Syndrome (PBS), as defined by the International Continence Society, is "the complaint of suprapubic pain related to bladder filling, accompanied by other symptoms, such as increased daytime and night-time frequency, in the absence of proven urinary infection or other obvious pathology. 2" PBS is a clinical description of disease based on the patient's symptoms and does not depend on urodynamic or cystoscopic findings. These symptoms may be related to interstitial cystitis, although diagnostic criteria are still lacking for this entity, and the relationship between PBS and interstitial cystitis is not clear. For clarity and compliance with current nomenclature, this protocol will use the term IC/PBS.
As with many chronic pain disorders, IC/PBS is poorly understood, poorly characterized, and treatment is mostly empirical and unsatisfactory. Several proposed etiologic theories include (1) increased bladder epithelial permeability, (2) activation of bladder mast cells, (3) allergic or autoimmune processes, (4) toxic substance(s) in the urine, (5) occult infection, (6) neuropathic changes, and (7) neurogenic inflammation. However, none of these mechanisms have been conclusively shown to be responsible for IC/PBS. Estimates of prevalence of the syndromes vary widely. In 1990 interstitial cystitis (IC) was thought to affect as many as 500,000 U.S. citizens, with 25% of patients under age 25.3 More recently however, using expanded definitions of PBS now exceed 10 million.4 Quality of life with IC/PBS can be worse than end stage renal disease.5 The recent pilot study of manual physical therapies for Urologic Pelvic Pain demonstrated feasibility of recruitment, and promising benefit of myofascial tissue manipulation (MTM) (ref manuscript#1). In that pilot study, 47 participants were recruited to six centers with prior expertise in MTM. Of the 47 participants, 24 were females with IC/PBS, and 23 were males -- 2 with IC/PBS and 21 with CP/CPPS. Motivated by the promising findings in that pilot study, this protocol aims to investigate whether those initial results are generalizable in an expanded phase 3 clinical trial, in which we include other therapists from other centers. However, due to the gender-specific findings of the pilot study, and the limited resources available, this protocol is focused on replicating the initial pilot study exclusively in women with IC/PBS.
Although the pain of IC/PBS is poorly understood, almost all clinicians agree that there is almost always some chronic tension and tenderness of the pelvic floor musculature present in UPPS patients,8-10 and it is possible that these myofascial abnormalities contribute significantly to the pain of IC/PBS. For example, Hetrick et al11 compared the surface EMG signals from men with CPPS to those from men without chronic pain, and found that there was greater EMG instability in men with CPPS, along with increased baseline tonicity, and instability with lowered voluntary endurance contraction amplitude.
Whether these musculoskeletal abnormalities of the abdominal wall and pelvic floor musculature found in IC/PBS sufferers represent primary or secondary phenomena remains unknown. It is possible that pelvic visceral pain leads to chronic contraction of regional skeletal musculature, leading to overuse injury and pain. It is also possible that primary pelvic myofascial problems lead to painful and weakened pelvic floor musculature, which also functions poorly to inhibit the urgency associated with bladder filling.
Our prior study of manual physical therapy suggested benefit of MTM over GTM. Translation of those office practices into the research setting was apparently successful in centers that participated in the first trial. We propose to expand the number of treating therapists to include 11 study centers, in order to determine whether the results of the first trial can be generalized, at least in the research setting. However, due to the gender-specific findings, this expanded replication study will focus exclusively on women with IC/PBS.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01DK065209 | NIH | None | https://reporter.nih.gov/quic… | View |