Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2022-07-01
2024-03-31
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pressure (30 centimeters), Duration (1 minute), Number of times done (1)
Hydrodistention during cystoscope
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.
Pressure (30 centimeters), Duration (2 minute), Number of times done (1)
Hydrodistention during cystoscope
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.
Pressure (30 centimeters), Duration (1 minute), Number of times done (2)
Hydrodistention during cystoscope
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.
Pressure (80 centimeters), Duration (1 minute), Number of times done (1)
Hydrodistention during cystoscope
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.
Pressure (80 centimeters), Duration (2 minute), Number of times done (1)
Hydrodistention during cystoscope
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.
Pressure (80 centimeters), Duration (1 minute), Number of times done (2)
Hydrodistention during cystoscope
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.
Pressure (30 centimeters), Duration (2 minute), Number of times done (2)
Hydrodistention during cystoscope
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.
Pressure (80 centimeters), Duration (2 minute), Number of times done (2)
Hydrodistention during cystoscope
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.
Interventions
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Hydrodistention during cystoscope
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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James Clemens
Research Professor of Urology and Professor of Urology
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00212141
Identifier Type: -
Identifier Source: org_study_id
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