What is the Optimal Technique for Hydrodistention?
- Conditions
- Interstitial CystitisBladder Pain Syndrome
- Interventions
- Procedure: Hydrodistention during cystoscope
- Registration Number
- NCT05456308
- Lead Sponsor
- University of Michigan
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pressure (80 centimeters), Duration (1 minute), Number of times done (1) Hydrodistention during cystoscope - Pressure (30 centimeters), Duration (1 minute), Number of times done (1) Hydrodistention during cystoscope - Pressure (30 centimeters), Duration (1 minute), Number of times done (2) Hydrodistention during cystoscope - Pressure (80 centimeters), Duration (2 minute), Number of times done (1) Hydrodistention during cystoscope - Pressure (80 centimeters), Duration (1 minute), Number of times done (2) Hydrodistention during cystoscope - Pressure (30 centimeters), Duration (2 minute), Number of times done (1) Hydrodistention during cystoscope - Pressure (30 centimeters), Duration (2 minute), Number of times done (2) Hydrodistention during cystoscope - Pressure (80 centimeters), Duration (2 minute), Number of times done (2) Hydrodistention during cystoscope -
- Primary Outcome Measures
Name Time Method Changes in the interstitial cystitis symptom index (ICSI) from baseline to 1-month 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
Name Time Method Time spent in the post-anesthesia care unit (minutes) After procedure (approximate time frame is 60 minutes) Complication rates between different hydrodistention parameters (pressure, number of distention, and duration of distention) up to 30 days (after hydrodistention) 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 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 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 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 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 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.
Number of morphine milligram equivalents (MME) given in the post-anesthesia care unit After procedure (approximate time frame is 1 hour)
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States