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NCT Number: NCT05456308

What is the Optimal Technique for Hydrodistention?

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).

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Key information

Conditions

Interstitial Cystitis Bladder Pain Syndrome Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Complication rates between different hydrodistention parameters (pressure, number of distention, and duration of distention)

    Time frame: up to 30 days (after hydrodistention)

    These include bladder rupture, urinary tract infection/sepsis, prolonged retention, unplanned readmissions within 30 days.

  2. Changes in the genitourinary pain index (GUPI) from baseline to 1- month

    Time frame: 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.

  3. Changes in the genitourinary pain index (GUPI) from baseline to 1-week

    Time frame: 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.

  4. Changes in the genitourinary pain index (GUPI) baseline to 3-months

    Time frame: 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.

  5. Changes in the interstitial cystitis symptom index (ICSI) from baseline to 1-week

    Time frame: 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.

  6. Changes in the interstitial cystitis symptom index (ICSI) from baseline to 3-months

    Time frame: 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.

  7. Time spent in the post-anesthesia care unit (minutes)

    Time frame: After procedure (approximate time frame is 60 minutes)

  8. Number of morphine milligram equivalents (MME) given in the post-anesthesia care unit

    Time frame: After procedure (approximate time frame is 1 hour)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 13, 2022
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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