What is the Optimal Technique for Hydrodistention?

NCT05456308 | Completed

• 1 other identifier: HUM00212141
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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).

Conditions

Interstitial Cystitis; Bladder Pain Syndrome

Keywords

Hydrodistension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  up to 30 days (after hydrodistention)

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

  baseline to 1- month

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

  baseline to 1-week

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

  baseline to 3-months

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

  baseline to 1-week

Study Arms (8)

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

Interventions

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.

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and statistician blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor of Urology and Professor of Urology

Model Details: 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 Record Dates

• First Submitted: July 5, 2022
• First Posted: July 13, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)