What is the Optimal Technique for Hydrodistention?

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Interstitial Cystitis, Bladder Pain Syndrome

Intervention / Treatment
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* Procedure: Hydrodistention during cystoscope


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pressure (30 centimeters), Duration (1 minute), Number of times done (1)<br> | Procedure: Hydrodistention during cystoscope<br>* 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.<br>|
| Experimental: Pressure (30 centimeters), Duration (2 minute), Number of times done (1)<br> | Procedure: Hydrodistention during cystoscope<br>* 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.<br>|
| Experimental: Pressure (30 centimeters), Duration (1 minute), Number of times done (2)<br> | Procedure: Hydrodistention during cystoscope<br>* 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.<br>|
| Experimental: Pressure (80 centimeters), Duration (1 minute), Number of times done (1)<br> | Procedure: Hydrodistention during cystoscope<br>* 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.<br>|
| Experimental: Pressure (80 centimeters), Duration (2 minute), Number of times done (1)<br> | Procedure: Hydrodistention during cystoscope<br>* 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.<br>|
| Experimental: Pressure (80 centimeters), Duration (1 minute), Number of times done (2)<br> | Procedure: Hydrodistention during cystoscope<br>* 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.<br>|
| Experimental: Pressure (30 centimeters), Duration (2 minute), Number of times done (2)<br> | Procedure: Hydrodistention during cystoscope<br>* 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.<br>|
| Experimental: Pressure (80 centimeters), Duration (2 minute), Number of times done (2)<br> | Procedure: Hydrodistention during cystoscope<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 30 days (after hydrodistention) | 
| 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. | baseline to 1- month | 
| 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. | baseline to 1-week | 
| 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. | baseline to 3-months | 
| 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. | baseline to 1-week | 
| 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. | baseline to 3-months | 
| Time spent in the post-anesthesia care unit (minutes) |  | After procedure (approximate time frame is 60 minutes) | 
| Number of morphine milligram equivalents (MME) given in the post-anesthesia care unit |  | After procedure (approximate time frame is 1 hour) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydrodistension