Clinical trial NCT05456308: 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
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Cystitis
Bladder Pain Syndrome
Keywords: Hydrodistension
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in the interstitial cystitis symptom index (ICSI) from baseline to 1-month
timeFrame: baseline to 1 month
Secondary outcomes:
measure: Complication rates between different hydrodistention parameters (pressure, number of distention, and duration of distention)
timeFrame: up to 30 days (after hydrodistention)
measure: Changes in the genitourinary pain index (GUPI) from baseline to 1- month
timeFrame: baseline to 1- month
measure: Changes in the genitourinary pain index (GUPI) from baseline to 1-week
timeFrame: baseline to 1-week
measure: Changes in the genitourinary pain index (GUPI) baseline to 3-months
timeFrame: baseline to 3-months
measure: Changes in the interstitial cystitis symptom index (ICSI) from baseline to 1-week
timeFrame: baseline to 1-week
measure: Changes in the interstitial cystitis symptom index (ICSI) from baseline to 3-months
timeFrame: baseline to 3-months
measure: Time spent in the post-anesthesia care unit (minutes)
timeFrame: After procedure (approximate time frame is 60 minutes)
measure: Number of morphine milligram equivalents (MME) given in the post-anesthesia care unit
timeFrame: After procedure (approximate time frame is 1 hour)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: