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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pressure (30 centimeters), Duration (1 minute), Number of times done (1) | Experimental |
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| Pressure (30 centimeters), Duration (2 minute), Number of times done (1) | Experimental |
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| Pressure (30 centimeters), Duration (1 minute), Number of times done (2) | Experimental |
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| Pressure (80 centimeters), Duration (1 minute), Number of times done (1) | Experimental |
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| Pressure (80 centimeters), Duration (2 minute), Number of times done (1) | Experimental |
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| Pressure (80 centimeters), Duration (1 minute), Number of times done (2) | Experimental |
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| Pressure (30 centimeters), Duration (2 minute), Number of times done (2) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrodistention during cystoscope | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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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.
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Patients and statistician blinded
| Experimental |
|
| Pressure (80 centimeters), Duration (2 minute), Number of times done (2) | Experimental |
|
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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) |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |