Interstitial CystitisNCT05456308
What is the Optimal Technique for Hydrodistention?
A study testing Hydrodistention during cystoscope in people with Interstitial Cystitis and Bladder Pain Syndrome, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Cystitis, Bladder Pain Syndrome
- What is being tested?
- Hydrodistention during cystoscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Being tested
- Hydrodistention during cystoscope
- Keywords
- Hydrodistension
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrodistention during cystoscopeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pressure (30 centimeters), Duration (1 minute), Number of times done (1) | Experimental | Not described Receives: Procedure: Hydrodistention during cystoscope |
| Pressure (30 centimeters), Duration (2 minute), Number of times done (1) | Experimental | Not described Receives: Procedure: Hydrodistention during cystoscope |
| Pressure (30 centimeters), Duration (1 minute), Number of times done (2) | Experimental | Not described Receives: Procedure: Hydrodistention during cystoscope |
| Pressure (80 centimeters), Duration (1 minute), Number of times done (1) | Experimental | Not described Receives: Procedure: Hydrodistention during cystoscope |
| Pressure (80 centimeters), Duration (2 minute), Number of times done (1) | Experimental | Not described Receives: Procedure: Hydrodistention during cystoscope |
| Pressure (80 centimeters), Duration (1 minute), Number of times done (2) | Experimental | Not described Receives: Procedure: Hydrodistention during cystoscope |
| Pressure (30 centimeters), Duration (2 minute), Number of times done (2) | Experimental | Not described Receives: Procedure: Hydrodistention during cystoscope |
| Pressure (80 centimeters), Duration (2 minute), Number of times done (2) | Experimental | Not described Receives: Procedure: Hydrodistention during cystoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to 1 month
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline to 3-months
Time spent in the post-anesthesia care unit (minutes)
Measured: After procedure (approximate time frame is 60 minutes)
Number of morphine milligram equivalents (MME) given in the post-anesthesia care unit
Measured: After procedure (approximate time frame is 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Clemens, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456308
- Sponsor's protocol ID
- HUM00212141
- Status last verified
- Oct 2024
- First submitted
- 5 Jul 2022
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05456308
- Acronym / sponsor ID
- HUM00212141
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Keywords
- Hydrodistension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pressure (30 centimeters), Duration (1 minute), Number of times done (1) | Experimental | Procedure: Hydrodistention during cystoscope |
| Pressure (30 centimeters), Duration (2 minute), Number of times done (1) | Experimental | Procedure: Hydrodistention during cystoscope |
| Pressure (30 centimeters), Duration (1 minute), Number of times done (2) | Experimental | Procedure: Hydrodistention during cystoscope |
| Pressure (80 centimeters), Duration (1 minute), Number of times done (1) | Experimental | Procedure: Hydrodistention during cystoscope |
| Pressure (80 centimeters), Duration (2 minute), Number of times done (1) | Experimental | Procedure: Hydrodistention during cystoscope |
| Pressure (80 centimeters), Duration (1 minute), Number of times done (2) | Experimental | Procedure: Hydrodistention during cystoscope |
| Pressure (30 centimeters), Duration (2 minute), Number of times done (2) | Experimental | Procedure: Hydrodistention during cystoscope |
| Pressure (80 centimeters), Duration (2 minute), Number of times done (2) | Experimental | Procedure: Hydrodistention during cystoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrodistention during cystoscopeHydrodistention 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. | Procedure or surgery | Pressure (30 centimeters), Duration (1 minute), Number of times done (1), Pressure (30 centimeters), Duration (1 minute), Number of times done (2), Pressure (30 centimeters), Duration (2 minute), Number of times done (1), Pressure (30 centimeters), Duration (2 minute), Number of times done (2), Pressure (80 centimeters), Duration (1 minute), Number of times done (1), Pressure (80 centimeters), Duration (1 minute), Number of times done (2), Pressure (80 centimeters), Duration (2 minute), Number of times done (1), Pressure (80 centimeters), Duration (2 minute), Number of times done (2) |
Primary outcome
Changes in the interstitial cystitis symptom index (ICSI) from baseline to 1-month
Time frame: 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.
8 secondary outcomes
Complication rates between different hydrodistention parameters (pressure, number of distention, and duration of distention)
Time frame: up to 30 days (after hydrodistention)
Changes in the genitourinary pain index (GUPI) from baseline to 1- month
Time frame: baseline to 1- month
Changes in the genitourinary pain index (GUPI) from baseline to 1-week
Time frame: baseline to 1-week
Changes in the genitourinary pain index (GUPI) baseline to 3-months
Time frame: baseline to 3-months
Changes in the interstitial cystitis symptom index (ICSI) from baseline to 1-week
Time frame: baseline to 1-week
Changes in the interstitial cystitis symptom index (ICSI) from baseline to 3-months
Time frame: baseline to 3-months
Time spent in the post-anesthesia care unit (minutes)
Time frame: After procedure (approximate time frame is 60 minutes)
Number of morphine milligram equivalents (MME) given in the post-anesthesia care unit
Time frame: After procedure (approximate time frame is 1 hour)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrodistention during cystoscope in people with Interstitial Cystitis and Bladder Pain Syndrome, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the interstitial cystitis symptom index (ICSI) from baseline to 1-month (time frame: baseline to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.