Back to resultsWhat is the Optimal Technique for Hydrodistention?
Primary Purpose
Interstitial Cystitis, Bladder Pain Syndrome
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hydrodistention during cystoscope
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Cystitis focused on measuring Hydrodistension
Eligibility Criteria
Inclusion Criteria:
- Patients with IC/BPS who have failed first/second line treatments (behavioral therapy, medications) for greater than 3 months
- Have not had hydrodistention performed in the past 3 months
- Have not had botox or Percutaneous tibial nerve stimulation (PTNS) performed in the past 3 months
Exclusion Criteria:
- Patients with known hunner's lesions
- Patients with interstim
- Patients with positive urinalysis/culture consistent with urinary tract infection (UTI)
- History of urethral, bladder, prostate, uterine, cervical, vaginal cancer
- History of augmentation cystoplasty or cystectomy
- History of urethral diverticulum, urethral stricture, pelvic radiation
- Patients with spinal cord injuries
- History of dementia, parkinson's disease, multiple sclerosis, spina bifida, paraplegia/quadriplegia, cerebral palsy, stroke
- Neurogenic bladder patients
- Anuric patients
- Tuberculous cystitis
- Cyclophosphamide treatment
- Pregnant patients
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Pressure (30 centimeters), Duration (1 minute), Number of times done (1)
Pressure (30 centimeters), Duration (2 minute), Number of times done (1)
Pressure (30 centimeters), Duration (1 minute), Number of times done (2)
Pressure (80 centimeters), Duration (1 minute), Number of times done (1)
Pressure (80 centimeters), Duration (2 minute), Number of times done (1)
Pressure (80 centimeters), Duration (1 minute), Number of times done (2)
Pressure (30 centimeters), Duration (2 minute), Number of times done (2)
Pressure (80 centimeters), Duration (2 minute), Number of times done (2)
Arm Description
Outcomes
Primary Outcome Measures
Changes in the interstitial cystitis symptom index (ICSI) from baseline to 1-month
Identify the optimal technique for hydrodistention, including the optimal pressure (30 vs 80cc), number of hydrodistentions (one vs two), duration of each hydrodistention (one vs two minutes) as quantified by Changes in the interstitial cystitis symptom index (ICSI)f rom baseline to 1-month.
The O'Leary-Sant questionnaire is composed of the Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI) which contains four questions related to urinary and pain symptoms. For the ICSI (score range: 0-19 points), 3 of the 4 questions utilize a range of 0-5 with 0 indicating the symptom is never experienced and 5 indicating the symptom is almost always experienced. The fourth question utilizes a range of 0-4 with 0 indicating the symptom is never experienced and 4 indicating the symptom is usually experienced. For the ICPI (score range: 0-16 points), all four questions utilize a range of 0-4 with 0 indicating it is no problem and 4 indicating it is a big problem.
Secondary Outcome Measures
Complication rates between different hydrodistention parameters (pressure, number of distention, and duration of distention)
These include bladder rupture, urinary tract infection/sepsis, prolonged retention, unplanned readmissions within 30 days.
Changes in the genitourinary pain index (GUPI) from baseline to 1- month
The GUPI questionnaire (score range: 0 - 45) contains nine overarching items related to urinary symptoms, pain, and impact on quality of life. A higher score denoting worse symptoms.
Changes in the genitourinary pain index (GUPI) from baseline to 1-week
The GUPI questionnaire (score range: 0 - 45) contains nine overarching items related to urinary symptoms, pain, and impact on quality of life. A higher score denoting worse symptoms.
Changes in the genitourinary pain index (GUPI) baseline to 3-months
The GUPI questionnaire (score range: 0 - 45) contains nine overarching items related to urinary symptoms, pain, and impact on quality of life. A higher score denoting worse symptoms.
Changes in the interstitial cystitis symptom index (ICSI) from baseline to 1-week
The O'Leary-Sant questionnaire is composed of the Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI) which contains four questions related to urinary and pain symptoms. For the ICSI (score range: 0-19 points), 3 of the 4 questions utilize a range of 0-5 with 0 indicating the symptom is never experienced and 5 indicating the symptom is almost always experienced. The fourth question utilizes a range of 0-4 with 0 indicating the symptom is never experienced and 4 indicating the symptom is usually experienced. For the ICPI (score range: 0-16 points), all four questions utilize a range of 0-4 with 0 indicating it is no problem and 4 indicating it is a big problem.
Changes in the interstitial cystitis symptom index (ICSI) from baseline to 3-months
The O'Leary-Sant questionnaire is composed of the Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI) which contains four questions related to urinary and pain symptoms. For the ICSI (score range: 0-19 points), 3 of the 4 questions utilize a range of 0-5 with 0 indicating the symptom is never experienced and 5 indicating the symptom is almost always experienced. The fourth question utilizes a range of 0-4 with 0 indicating the symptom is never experienced and 4 indicating the symptom is usually experienced. For the ICPI (score range: 0-16 points), all four questions utilize a range of 0-4 with 0 indicating it is no problem and 4 indicating it is a big problem.
Time spent in the post-anesthesia care unit (minutes)
Number of morphine milligram equivalents (MME) given in the post-anesthesia care unit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05456308
Brief Title
What is the Optimal Technique for Hydrodistention?
Official Title
What is the Optimal Technique for Hydrodistention? First Prospective Study Evaluating the Effect of Pressure, Duration and Number of Hydrodistentions on Patients With Interstitial Cystitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This research study is being done to learn what is the best way to perform hydrodistention. Eligible participants will be enrolled and have follow-up for three months after surgery.
The study team hypothesizes that changes in hydrodistention technique, including pressure, number of distention, and duration of distention, leads to no or minimal changes in symptom improvement for patients with Interstitial cystitis/bladder pain syndrome (IC/BPS).
Detailed Description
Hydrodistention is a procedure designed to treat bladder and pelvic symptoms in patients with interstitial cystitis. A camera is placed inside the bladder and the bladder is filled with fluid. This procedure "resets" the signals between the bladder and brain, in order to reduce the symptoms of interstitial cystitis (such as bladder pain, urinary urgency/frequency/dysuria, incontinence, incomplete emptying, etc).
However, it is still unknown the best way to perform hydrodistention. Doctors do not know how much fluid to put in the bladder, how long to keep the fluid in the bladder, and how many times to fill the bladder.
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
Hydrodistension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly selected to one of the arms described. There are three variables that they will be assigned: the pressure of fluid in the bladder that will be filled, the duration of time that the fluid will be held in the bladder, and the number of times the procedure is completed.
Masking
ParticipantOutcomes Assessor
Masking Description
Patients and statistician blinded
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pressure (30 centimeters), Duration (1 minute), Number of times done (1)
Arm Type
Experimental
Arm Title
Pressure (30 centimeters), Duration (2 minute), Number of times done (1)
Arm Type
Experimental
Arm Title
Pressure (30 centimeters), Duration (1 minute), Number of times done (2)
Arm Type
Experimental
Arm Title
Pressure (80 centimeters), Duration (1 minute), Number of times done (1)
Arm Type
Experimental
Arm Title
Pressure (80 centimeters), Duration (2 minute), Number of times done (1)
Arm Type
Experimental
Arm Title
Pressure (80 centimeters), Duration (1 minute), Number of times done (2)
Arm Type
Experimental
Arm Title
Pressure (30 centimeters), Duration (2 minute), Number of times done (2)
Arm Type
Experimental
Arm Title
Pressure (80 centimeters), Duration (2 minute), Number of times done (2)
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Hydrodistention during cystoscope
Intervention Description
Hydrodistention for treatment of interstitial cystitis will be performed. Participants will be randomly selected to one of the arms described. There are three variables that they will be assigned: the pressure of fluid in the bladder that will be filled, the duration of time that the fluid will be held in the bladder, and the number of times the procedure is completed.
Primary Outcome Measure Information:
Title
Changes in the interstitial cystitis symptom index (ICSI) from baseline to 1-month
Description
Identify the optimal technique for hydrodistention, including the optimal pressure (30 vs 80cc), number of hydrodistentions (one vs two), duration of each hydrodistention (one vs two minutes) as quantified by Changes in the interstitial cystitis symptom index (ICSI)f rom baseline to 1-month.
The O'Leary-Sant questionnaire is composed of the Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI) which contains four questions related to urinary and pain symptoms. For the ICSI (score range: 0-19 points), 3 of the 4 questions utilize a range of 0-5 with 0 indicating the symptom is never experienced and 5 indicating the symptom is almost always experienced. The fourth question utilizes a range of 0-4 with 0 indicating the symptom is never experienced and 4 indicating the symptom is usually experienced. For the ICPI (score range: 0-16 points), all four questions utilize a range of 0-4 with 0 indicating it is no problem and 4 indicating it is a big problem.
Time Frame
baseline to 1 month
Secondary Outcome Measure Information:
Title
Complication rates between different hydrodistention parameters (pressure, number of distention, and duration of distention)
Description
These include bladder rupture, urinary tract infection/sepsis, prolonged retention, unplanned readmissions within 30 days.
Time Frame
up to 30 days (after hydrodistention)
Title
Changes in the genitourinary pain index (GUPI) from baseline to 1- month
Description
The GUPI questionnaire (score range: 0 - 45) contains nine overarching items related to urinary symptoms, pain, and impact on quality of life. A higher score denoting worse symptoms.
Time Frame
baseline to 1- month
Title
Changes in the genitourinary pain index (GUPI) from baseline to 1-week
Description
The GUPI questionnaire (score range: 0 - 45) contains nine overarching items related to urinary symptoms, pain, and impact on quality of life. A higher score denoting worse symptoms.
Time Frame
baseline to 1-week
Title
Changes in the genitourinary pain index (GUPI) baseline to 3-months
Description
The GUPI questionnaire (score range: 0 - 45) contains nine overarching items related to urinary symptoms, pain, and impact on quality of life. A higher score denoting worse symptoms.
Time Frame
baseline to 3-months
Title
Changes in the interstitial cystitis symptom index (ICSI) from baseline to 1-week
Description
The O'Leary-Sant questionnaire is composed of the Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI) which contains four questions related to urinary and pain symptoms. For the ICSI (score range: 0-19 points), 3 of the 4 questions utilize a range of 0-5 with 0 indicating the symptom is never experienced and 5 indicating the symptom is almost always experienced. The fourth question utilizes a range of 0-4 with 0 indicating the symptom is never experienced and 4 indicating the symptom is usually experienced. For the ICPI (score range: 0-16 points), all four questions utilize a range of 0-4 with 0 indicating it is no problem and 4 indicating it is a big problem.
Time Frame
baseline to 1-week
Title
Changes in the interstitial cystitis symptom index (ICSI) from baseline to 3-months
Description
The O'Leary-Sant questionnaire is composed of the Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI) which contains four questions related to urinary and pain symptoms. For the ICSI (score range: 0-19 points), 3 of the 4 questions utilize a range of 0-5 with 0 indicating the symptom is never experienced and 5 indicating the symptom is almost always experienced. The fourth question utilizes a range of 0-4 with 0 indicating the symptom is never experienced and 4 indicating the symptom is usually experienced. For the ICPI (score range: 0-16 points), all four questions utilize a range of 0-4 with 0 indicating it is no problem and 4 indicating it is a big problem.
Time Frame
baseline to 3-months
Title
Time spent in the post-anesthesia care unit (minutes)
Time Frame
After procedure (approximate time frame is 60 minutes)
Title
Number of morphine milligram equivalents (MME) given in the post-anesthesia care unit
Time Frame
After procedure (approximate time frame is 1 hour)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with IC/BPS who have failed first/second line treatments (behavioral therapy, medications) for greater than 3 months
Have not had hydrodistention performed in the past 3 months
Have not had botox or Percutaneous tibial nerve stimulation (PTNS) performed in the past 3 months
Exclusion Criteria:
Patients with known hunner's lesions
Patients with interstim
Patients with positive urinalysis/culture consistent with urinary tract infection (UTI)
History of urethral, bladder, prostate, uterine, cervical, vaginal cancer
History of augmentation cystoplasty or cystectomy
History of urethral diverticulum, urethral stricture, pelvic radiation
Patients with spinal cord injuries
History of dementia, parkinson's disease, multiple sclerosis, spina bifida, paraplegia/quadriplegia, cerebral palsy, stroke
Neurogenic bladder patients
Anuric patients
Tuberculous cystitis
Cyclophosphamide treatment
Pregnant patients
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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What is the Optimal Technique for Hydrodistention?
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