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Supervised Exercise as a Therapeutic Strategy for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Primary Purpose

Interstitial Cystitis, Bladder Pain Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise regimen
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring exercise, interstitial cystitis, bladder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Adult females (>18 years and <80 years) with a previously established clinical diagnosis of Interstitial cystitis/bladder pain syndrome (IC/BPS) will be eligible to participate Must speak English The clinical diagnosis of IC/BPS will be based on the recently published American Urological Association Guidelines definition: "An unpleasant sensation (pain, pressure, or discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms for more than six weeks duration, in the absence of infection or other identifiable causes" The diagnosis will be confirmed by a urologist who specializes in the treatment of patients with IC/BPS Exclusion Criteria: Study participants must be fully ambulatory without the use of a cane, walker, or wheelchair Study participants must be able to tolerate moderate aerobic exercise. It will also be required that a physician clear any subjects entering the exercise program who have signs and symptoms suggestive of cardiovascular, cerebrovascular, metabolic, or renal disease and have been active 3 days per week for 30 minutes each day Any history of bladder cancer, uterine cancer, ovarian cancer, vaginal cancer, the current placement of a catheter, urethral diverticulum, spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida, cyclophosphamide treatment, radiation cystitis, bladder tuberculosis, or are experiencing an active genital herpes episode Pregnant women are not eligible for this study

Sites / Locations

  • Wake Forest University Health SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise treatment group

Arm Description

This group will serve as both their own controls and for the experimental intervention. They will take surveys to record bladder symptoms and quality of life before undergoing exercise. They will then take the same surveys after exercise and their scores will be compared.

Outcomes

Primary Outcome Measures

Interstitial Cystitis Symptom Index (ICSI) Scores
Participants answer a series of questions to get a final score. Scores range from 0-20, with 0 being no symptoms and 20 the most severe.
Interstitial Cystitis Problem (ICPI) Index Scores
Participants answer a series of questions to get a final score. Scores range from 0-16, with 0 being no symptoms and 16 the most severe.
Interstitial Cystitis Symptom Index (ICSI) Scores
Participants answer a series of questions to get a final score. Scores range from 0-20, with 0 being no symptoms and 20 the most severe.
Interstitial Cystitis Problem (ICPI) Index Scores
Participants answer a series of questions to get a final score. Scores range from 0-16, with 0 being no symptoms and 16 the most severe.
Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) Scores
This survey is used to grade people with chronic pelvic pain. Participants answer a series of questions. Scores range between 0 and 35, and studies have indicated that a score greater than 12 is indicative of significant symptoms
Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) Scores
This survey is used to grade people with chronic pelvic pain. Participants answer a series of questions. Scores range between 0 and 35, and studies have indicated that a score greater than 12 is indicative of significant symptoms
Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) Scores
This survey is used to grade people with chronic pelvic pain. Participants answer a series of questions. Scores range between 0 and 35, and studies have indicated that a score greater than 12 is indicative of significant symptoms

Secondary Outcome Measures

Change in the Short Form 36 (SF-36) Health Survey Scores
The SF-36 is a questionnaire that consists of 8 subsections of 36 total questions. The sections are Physical functioning (10 items), Role limitations due to physical health (4 items), Role limitations due to emotional problems (4 items), Energy/fatigue (4 items), Emotional well-being (5 items), Social functioning (2 items), Pain (2 items), General health (5 items). Aggregate scores for each domain range from 0 to 100, compiled as a percentage - where the higher the score, the more favorable the health state of the patient.
Changes in Composite Autonomic Symptom Score (COMPASS-31) Scores
The test has 6 domains looking at autonomic symptoms: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder and pupillomotor. The six domain scores sum to a total COMPASS 31 score of 0 to 100, and a higher COMPASS 31 score indicates more severe autonomic symptoms.

Full Information

First Posted
January 16, 2023
Last Updated
September 26, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
University of North Carolina, Greensboro
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1. Study Identification

Unique Protocol Identification Number
NCT05699551
Brief Title
Supervised Exercise as a Therapeutic Strategy for Interstitial Cystitis/Bladder Pain Syndrome
Acronym
IC/BPS
Official Title
Supervised Exercise as a Therapeutic Strategy for Interstitial Cystitis/Bladder Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
University of North Carolina, Greensboro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, the efficacy of exercise to improve interstitial cystitis/bladder pain syndrome symptoms and quality of life will be investigated.
Detailed Description
Effective treatment for symptoms associated with interstitial cystitis/bladder pain syndrome is a significant clinical challenge problem due to the lack of insight into disease etiology/pathophysiology, costly and potentially invasive procedures, and a lack of research into potential therapeutics. The primary objective is to determine if a supervised exercise program by a trained exercise physiologist can relieve pain and improve urinary and bladder symptoms in patients with interstitial cystitis/bladder pain syndrome. This has the potential to open enormous future avenues of research, save both patients and the healthcare system cost, and most importantly improve patients' lives. A second objective of this study is to determine if exercise alters depressive symptoms, often a comorbid diagnosis, in patients with interstitial cystitis/bladder pain syndrome. A third objective of this study is to examine urinary markers of inflammation before and after exercise in patients with interstitial cystitis/bladder pain syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Bladder Pain Syndrome
Keywords
exercise, interstitial cystitis, bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise treatment group
Arm Type
Experimental
Arm Description
This group will serve as both their own controls and for the experimental intervention. They will take surveys to record bladder symptoms and quality of life before undergoing exercise. They will then take the same surveys after exercise and their scores will be compared.
Intervention Type
Behavioral
Intervention Name(s)
Exercise regimen
Intervention Description
Exercise will take place Monday, Wednesday, and Friday from 12:00-1:00 pm for 4 months. Every participant will be screened for Coronavirus-19 prior to each exercise session. Aerobic exercise will consist of walking, beginning with a 10-minute duration, with gradual progression to 20 minutes. Muscle strength and endurance and range-of-motion exercise will then be performed. Muscle strength and endurance training will begin using no weight and performing one set of 6 repetitions. Progression using added resistance in the form of dumbbell weights (1-6 lbs.) and increased sets and repetitions will be applied as Subjects become increasingly fit. For static range of motion exercise, positions will be held for 10-15 seconds in the beginning and increased over time. Exercise will be kept at a moderate level of intensity. Each session will then end with relaxation training.
Primary Outcome Measure Information:
Title
Interstitial Cystitis Symptom Index (ICSI) Scores
Description
Participants answer a series of questions to get a final score. Scores range from 0-20, with 0 being no symptoms and 20 the most severe.
Time Frame
baseline
Title
Interstitial Cystitis Problem (ICPI) Index Scores
Description
Participants answer a series of questions to get a final score. Scores range from 0-16, with 0 being no symptoms and 16 the most severe.
Time Frame
month 2
Title
Interstitial Cystitis Symptom Index (ICSI) Scores
Description
Participants answer a series of questions to get a final score. Scores range from 0-20, with 0 being no symptoms and 20 the most severe.
Time Frame
month 2
Title
Interstitial Cystitis Problem (ICPI) Index Scores
Description
Participants answer a series of questions to get a final score. Scores range from 0-16, with 0 being no symptoms and 16 the most severe.
Time Frame
month 4
Title
Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) Scores
Description
This survey is used to grade people with chronic pelvic pain. Participants answer a series of questions. Scores range between 0 and 35, and studies have indicated that a score greater than 12 is indicative of significant symptoms
Time Frame
baseline
Title
Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) Scores
Description
This survey is used to grade people with chronic pelvic pain. Participants answer a series of questions. Scores range between 0 and 35, and studies have indicated that a score greater than 12 is indicative of significant symptoms
Time Frame
month 2
Title
Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) Scores
Description
This survey is used to grade people with chronic pelvic pain. Participants answer a series of questions. Scores range between 0 and 35, and studies have indicated that a score greater than 12 is indicative of significant symptoms
Time Frame
month 4
Secondary Outcome Measure Information:
Title
Change in the Short Form 36 (SF-36) Health Survey Scores
Description
The SF-36 is a questionnaire that consists of 8 subsections of 36 total questions. The sections are Physical functioning (10 items), Role limitations due to physical health (4 items), Role limitations due to emotional problems (4 items), Energy/fatigue (4 items), Emotional well-being (5 items), Social functioning (2 items), Pain (2 items), General health (5 items). Aggregate scores for each domain range from 0 to 100, compiled as a percentage - where the higher the score, the more favorable the health state of the patient.
Time Frame
baseline, month 2, month 4
Title
Changes in Composite Autonomic Symptom Score (COMPASS-31) Scores
Description
The test has 6 domains looking at autonomic symptoms: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder and pupillomotor. The six domain scores sum to a total COMPASS 31 score of 0 to 100, and a higher COMPASS 31 score indicates more severe autonomic symptoms.
Time Frame
baseline, month 2, month 4
Other Pre-specified Outcome Measures:
Title
Changes in inflammatory urinary biomarkers
Description
Urine samples will be obtained at baseline and at the end of the 4 month exercise period from participants. The urine will then be analyzed for biomarkers of inflammation using a Luminex High Performance Assay. Any decrease in the levels of biomarkers of inflammation in the urine is the outcome of interest.
Time Frame
baseline, 4 months
Title
Post-regimen review
Description
After the exercise program concludes, participants will be contacted via phone or email and asked to comment on the program and make suggestions for improvement. This will include things such as if they would recommend the program to friends/family, if they have continued to exercise and/or will continue to exercise on their own time, and any portions of the program they would change or do differently.
Time Frame
4 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult females (>18 years and <80 years) with a previously established clinical diagnosis of Interstitial cystitis/bladder pain syndrome (IC/BPS) will be eligible to participate Must speak English The clinical diagnosis of IC/BPS will be based on the recently published American Urological Association Guidelines definition: "An unpleasant sensation (pain, pressure, or discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms for more than six weeks duration, in the absence of infection or other identifiable causes" The diagnosis will be confirmed by a urologist who specializes in the treatment of patients with IC/BPS Exclusion Criteria: Study participants must be fully ambulatory without the use of a cane, walker, or wheelchair Study participants must be able to tolerate moderate aerobic exercise. It will also be required that a physician clear any subjects entering the exercise program who have signs and symptoms suggestive of cardiovascular, cerebrovascular, metabolic, or renal disease and have been active 3 days per week for 30 minutes each day Any history of bladder cancer, uterine cancer, ovarian cancer, vaginal cancer, the current placement of a catheter, urethral diverticulum, spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida, cyclophosphamide treatment, radiation cystitis, bladder tuberculosis, or are experiencing an active genital herpes episode Pregnant women are not eligible for this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen J Walker, PhD
Phone
3367493574
Email
swalker@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maxwell L Sandberg, MD
Phone
2489045200
Email
mlsandbe@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Walker, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen J Walker, PhD
Phone
336-749-3574
Email
swalker@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Max L Sandberg, MD
Phone
2489045200
Email
mlsandbe@wakehealth.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Supervised Exercise as a Therapeutic Strategy for Interstitial Cystitis/Bladder Pain Syndrome

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