What is the Optimal Technique for Hydrodistention?

University of Michigan

Status: Completed

Conditions: Interstitial Cystitis; Bladder Pain Syndrome

Treatments: Procedure: Hydrodistention during cystoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT05456308

HUM00212141

Details and patient eligibility

About

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).

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 8 patient groups

Pressure (30 centimeters), Duration (1 minute), Number of times done (1)

Experimental group

Treatment:

Procedure: Hydrodistention during cystoscope

Pressure (30 centimeters), Duration (2 minute), Number of times done (1)

Experimental group

Treatment:

Procedure: Hydrodistention during cystoscope

Pressure (30 centimeters), Duration (1 minute), Number of times done (2)

Experimental group

Treatment:

Procedure: Hydrodistention during cystoscope

Pressure (80 centimeters), Duration (1 minute), Number of times done (1)

Experimental group

Treatment:

Procedure: Hydrodistention during cystoscope

Pressure (80 centimeters), Duration (2 minute), Number of times done (1)

Experimental group

Treatment:

Procedure: Hydrodistention during cystoscope

Pressure (80 centimeters), Duration (1 minute), Number of times done (2)

Experimental group

Treatment:

Procedure: Hydrodistention during cystoscope

Pressure (30 centimeters), Duration (2 minute), Number of times done (2)

Experimental group

Treatment:

Procedure: Hydrodistention during cystoscope

Pressure (80 centimeters), Duration (2 minute), Number of times done (2)

Experimental group

Treatment:

Procedure: Hydrodistention during cystoscope