Amplifying Sensation in Underactive Bladder

Summary

The purpose of this study is to determine the influence of intravesical (bladder) electrical stimulation and intraurethral electrical stimulation on bothersome symptoms and bladder function in neurologically-intact adult women with underactive bladder. The investigators hypothesize that electrical stimulation will decrease bothersome urinary symptoms relative to baseline and increase voided percentage during pressure-flow studies compared to their routine clinical exam.

Conditions

• Urinary Bladder, Underactive

Interventions

DEVICE

Neurometer Neurotron CPT

All participants will undergo CPT testing. A Neurotron catheter (12-French) with electrode will be inserted through the urethra into the bladder. The catheter balloon will be inflated and positioned at the urethrovesical junction to stimulate the urethra 10-14 mm from the bladder neck. For bladder stimulation, the catheter balloon will be deflated and the catheter will be advanced into the bladder. The device will deliver sine wave stimulus pulses at 5, 250, and 2,000 Hz. CPT will be established using an automated forced choice paradigm by the method of levels. Testing order of the bladder and urethra will be randomized between participants.

PROCEDURE

Cystometry

After bladder stimulation or during intraurethral stimulation, cystometry will be performed to assess bladder sensation and storage. A dual-chamber 8-French catheter will be passed through the urethra into the bladder for retrograde filling. A second 8-French catheter will be placed in the vagina to measure intra-abdominal pressure. A stimulation electrode catheter will only be inserted in the intraurethral stimulation arm. EMG pads will then be placed at 3 and 9 o'clock on each side of the perineum. The bladder will then be filled with room-temperature sterile saline solution in a retrograde fashion using a pump. Bladder sensation and urgency will be assessed while filling.

PROCEDURE

Pressure-flow study

A pressure flow study will be performed to evaluate voiding function after stimulation. The transurethral and intra-vaginal catheters are left in place after cystometry and the participant will be asked to void around them, into a commode. Bladder and abdominal pressures will be recorded, as well as urine flow over time.

Sponsors & Collaborators

• Duke University

  lead OTHER

Principal Investigators

• Cindy L Amundsen, MD · Duke University

• Em Abbott, PhD · Duke University

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-01

Primary Completion

2024-09-04

Completion

2024-09-27

FDA Device

Yes

Countries

• United States

Study Locations