What is the Optimal Technique for Hydrodistention?

Interstitial Cystitis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05456308
• Other study ID #: HUM00212141
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 96
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Pain Syndrome
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time spent in the post-anesthesia care unit (minutes)		After procedure (approximate time frame is 60 minutes)
Secondary	Number of morphine milligram equivalents (MME) given in the post-anesthesia care unit		After procedure (approximate time frame is 1 hour)