Amplifying Sensation in Underactive Bladder

NCT04516434 | Completed Results DMC FDA Device

• 1 other identifier: Pro00106457
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

electrical stimulation; urodynamics; bladder; urethra

Outcome Measures

Primary Outcomes (2)

• Voiding Efficiency

  Use of intraurethral electrical stimulation or intravesical electrical stimulation to assess increase in voided percentage during pressure-flow studies. Voiding efficiency is calculated as voided volume divided by the sum of voided volume and residual volume.

  Baseline, pressure-flow study (up to 60 minutes)

• Change in Bothersome Symptoms and Sensation

  Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29) to assess whether electrical stimulation decreases urinary bothersome symptoms and increases bladder sensation during filling and emptying. Scores range from 0 (least severe) to 100 (most severe). Higher scores indicate greater severity of lower urinary tract symptoms.

  baseline and post study procedures, up to 60 minutes

Secondary Outcomes (4)

• Current Perception Threshold

  CPT, up to 60 minutes

• Cystometry Volume

  cystometry before stimulation and after stimulation (up to 60 minutes)

• Bladder Contraction Strength

  Baseline, pressure-flow study (up to 60 minutes)

• Bladder Contraction Duration

  Baseline, pressure-flow study (up to 60 minutes)

Study Arms (2)

Intraurethral Electrical Stimulation

EXPERIMENTAL

This procedure is specific to the urethral stimulation arm. A sterile stimulation catheter (custom, 7-French) will be placed in the urethra and positioned with the electrode contact 10-14 mm from the bladder neck to stimulate the proximal urethra. A single return electrode will also be placed on the abdominal skin above the pubic bone. Stimuli will be delivered as 0.2 ms charge-balanced biphasic rectangular current pulses. Stimulation frequency will be 2-20 Hz and amplitude will be adjusted individually to 80% of the maximum tolerable intensity. Electrical stimulation will be applied to the proximal urethra at "strong desire to void" during cystometry. The participant will then be given permission to void at "maximum cystometric capacity" with continuous intraurethral stimulation.

Device: Neurometer Neurotron CPT; Procedure: Cystometry; Procedure: Pressure-flow study

Intravesical Electrical Stimulation

EXPERIMENTAL

This procedure is specific to the bladder stimulation arm. A sterile stimulation catheter (custom, 7-French) will be placed in the bladder through the urethra and the electrode contacts will be positioned to be floating within the bladder. A single return electrode will also be placed on the abdominal skin above the pubic bone. Stimuli will be delivered as 0.2 ms charge-balanced biphasic rectangular current pulses. Stimulation frequency will be set at 20 Hz and amplitude will be adjusted individually to 80% of the maximum tolerable intensity. Electrical stimulation will be applied to bladder sensory nerves for up to 60 minutes prior to the start of urodynamic studies.

Device: Neurometer Neurotron CPT; Procedure: Cystometry; Procedure: Pressure-flow study

Interventions

Neurometer Neurotron CPT DEVICE

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.

Intraurethral Electrical Stimulation; Intravesical Electrical Stimulation

Cystometry PROCEDURE

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.

Intraurethral Electrical Stimulation; Intravesical Electrical Stimulation

Pressure-flow study PROCEDURE

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.

Intraurethral Electrical Stimulation; Intravesical Electrical Stimulation

Eligibility Criteria

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

You may qualify if:

• Females ages 18 and older
• Able to provide informed consent and agree to the study risks
• Willing to withdraw from medications affecting urination for the 48 hours prior to the procedure (e.g., alpha-adrenergic antagonists, cholinergic agonists, cholinesterase inhibitors)
• Has the below response to 2 of the 3 questions:
• Questions regarding self-reported poor sensation during bladder filling or emptying (one or more of the below)
• In the past 7 days, where did the participant feel sensations when needing to urinate? Answer: "No" response for Bladder Area
• In the past 7 days, how often did the participant have no sensation of urine flow while urinating? Answer: "Most of the time" or "Every time" response
• In the past 7 days, how often did the participant feel that the bladder was not completely empty after urination? Answer: "Most of the time" or "Every time" response
• Questions regarding self-reported bothersome urinary symptoms (one or more of the below)
• In the past 7 days, how satisfied was the participant with bladder function? Answer: "Not at all satisfied" or "Somewhat satisfied" response
• In the past 7 days, how bothered was the participant by urinary symptoms? Answer: "Very bothered" or "Extremely bothered" response
• Standard uroflowmetry with a voiding efficiency (voided volume / voided volume + residual volume) of \< 80%, voided volume + residual volume must be \>150ml for measurement

You may not qualify if:

• Preexisting neurological impairment (e.g., spinal cord injury, multiple sclerosis, Guillain-Barre, cauda equina syndrome, cerebrovascular accident, Parkinson's disease, traumatic brain injury)
• Functional obstruction demonstrated by either elevated pelvic floor activity on EMG during standard pressure flow study or high tone pelvic floor on clinical exam)
• Pelvic organ prolapse beyond introitus
• Active urinary tract infection (candidate would be deferred until treated)
• Positive pregnancy test
• Less than 6 weeks postpartum
• Unevaluated hematuria
• Urethral stricture/stenosis
• Surgical obstruction i.e., urinary retention due to obstructive sling or other anti incontinence procedure
• Surgical procedures to increase bladder capacity (e.g., augmentation cystoplasty)
• Active sacral neuromodulation or ongoing posterior tibial nerve stimulation sessions
• Botulinum toxin injection in the past six months
• History of genitourinary or gastrointestinal cancer

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Medical Plaza Patterson Place

Durham, North Carolina, 27707, United States

Location

Related Publications (18)

• Fowler CJ, Griffiths D, de Groat WC. The neural control of micturition. Nat Rev Neurosci. 2008 Jun;9(6):453-66. doi: 10.1038/nrn2401.

  PMID: 18490916 BACKGROUND

• Jung SY, Fraser MO, Ozawa H, Yokoyama O, Yoshiyama M, De Groat WC, Chancellor MB. Urethral afferent nerve activity affects the micturition reflex; implication for the relationship between stress incontinence and detrusor instability. J Urol. 1999 Jul;162(1):204-12. doi: 10.1097/00005392-199907000-00069.

  PMID: 10379788 BACKGROUND

• Bump RC. The urethrodetrusor facilitative reflex in women: results of urethral perfusion studies. Am J Obstet Gynecol. 2000 Apr;182(4):794-802; discussion 802-4. doi: 10.1016/s0002-9378(00)70328-0.

  PMID: 10764455 BACKGROUND

• Osman NI, Chapple CR, Abrams P, Dmochowski R, Haab F, Nitti V, Koelbl H, van Kerrebroeck P, Wein AJ. Detrusor underactivity and the underactive bladder: a new clinical entity? A review of current terminology, definitions, epidemiology, aetiology, and diagnosis. Eur Urol. 2014 Feb;65(2):389-98. doi: 10.1016/j.eururo.2013.10.015. Epub 2013 Oct 26.

  PMID: 24184024 BACKGROUND

• Jeong SJ, Kim HJ, Lee YJ, Lee JK, Lee BK, Choo YM, Oh JJ, Lee SC, Jeong CW, Yoon CY, Hong SK, Byun SS, Lee SE. Prevalence and Clinical Features of Detrusor Underactivity among Elderly with Lower Urinary Tract Symptoms: A Comparison between Men and Women. Korean J Urol. 2012 May;53(5):342-8. doi: 10.4111/kju.2012.53.5.342. Epub 2012 May 18.

  PMID: 22670194 BACKGROUND

• Chapple CR, Osman NI, Birder L, van Koeveringe GA, Oelke M, Nitti VW, Drake MJ, Yamaguchi O, Abrams P, Smith PP. The underactive bladder: a new clinical concept? Eur Urol. 2015 Sep;68(3):351-3. doi: 10.1016/j.eururo.2015.02.030. Epub 2015 Mar 11.

  PMID: 25770481 BACKGROUND

• Gammie A, Kaper M, Dorrepaal C, Kos T, Abrams P. Signs and Symptoms of Detrusor Underactivity: An Analysis of Clinical Presentation and Urodynamic Tests From a Large Group of Patients Undergoing Pressure Flow Studies. Eur Urol. 2016 Feb;69(2):361-9. doi: 10.1016/j.eururo.2015.08.014. Epub 2015 Aug 28.

  PMID: 26318706 BACKGROUND

• Uren AD, Cotterill N, Harding C, Hillary C, Chapple C, Klaver M, Bongaerts D, Hakimi Z, Abrams P. Qualitative Exploration of the Patient Experience of Underactive Bladder. Eur Urol. 2017 Sep;72(3):402-407. doi: 10.1016/j.eururo.2017.03.045. Epub 2017 Apr 8.

  PMID: 28400168 BACKGROUND

• Miyazato M, Yoshimura N, Chancellor MB. The other bladder syndrome: underactive bladder. Rev Urol. 2013;15(1):11-22.

  PMID: 23671401 BACKGROUND

• Ukimura O, Ushijima S, Honjo H, Iwata T, Suzuki K, Hirahara N, Okihara K, Mizutani Y, Kawauchi A, Miki T. Neuroselective current perception threshold evaluation of bladder mucosal sensory function. Eur Urol. 2004 Jan;45(1):70-6. doi: 10.1016/j.eururo.2003.08.004.

  PMID: 14667519 BACKGROUND

• Kenton K, Simmons J, FitzGerald MP, Lowenstein L, Brubaker L. Urethral and bladder current perception thresholds: normative data in women. J Urol. 2007 Jul;178(1):189-92; discussion 192. doi: 10.1016/j.juro.2007.03.032. Epub 2007 May 17.

  PMID: 17499783 BACKGROUND

• Lee WC, Wu HP, Tai TY, Yu HJ, Chiang PH. Investigation of urodynamic characteristics and bladder sensory function in the early stages of diabetic bladder dysfunction in women with type 2 diabetes. J Urol. 2009 Jan;181(1):198-203. doi: 10.1016/j.juro.2008.09.021. Epub 2008 Nov 14.

  PMID: 19013605 BACKGROUND

• Cella D, Smith AR, Griffith JW, Flynn KE, Bradley CS, Gillespie BW, Kirkali Z, Talaty P, Jelovsek JE, Helfand BT, Weinfurt KP; LURN Study Group. A new outcome measure for LUTS: Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29) questionnaire. Neurourol Urodyn. 2019 Aug;38(6):1751-1759. doi: 10.1002/nau.24067. Epub 2019 Jun 21.

  PMID: 31225927 BACKGROUND

• Gladh G, Mattsson S, Lindstrom S. Intravesical electrical stimulation in the treatment of micturition dysfunction in children. Neurourol Urodyn. 2003;22(3):233-42. doi: 10.1002/nau.10078.

  PMID: 12707874 BACKGROUND

• Jiang CH, Lindstrom S. Optimal conditions for the long-term modulation of the micturition reflex by intravesical electrical stimulation: an experimental study in the rat. BJU Int. 1999 Mar;83(4):483-7. doi: 10.1046/j.1464-410x.1999.00947.x.

  PMID: 10210575 BACKGROUND

• Deng H, Liao L, Wu J, Chen G, Li X, Wang Z, Wan L. Clinical efficacy of intravesical electrical stimulation on detrusor underactivity: 8 Years of experience from a single center. Medicine (Baltimore). 2017 Sep;96(38):e8020. doi: 10.1097/MD.0000000000008020.

  PMID: 28930838 BACKGROUND

• Gustafson KJ, Creasey GH, Grill WM. A urethral afferent mediated excitatory bladder reflex exists in humans. Neurosci Lett. 2004 Apr 22;360(1-2):9-12. doi: 10.1016/j.neulet.2004.01.001.

  PMID: 15082166 BACKGROUND

• Yoo PB, Horvath EE, Amundsen CL, Webster GD, Grill WM. Multiple pudendal sensory pathways reflexly modulate bladder and urethral activity in patients with spinal cord injury. J Urol. 2011 Feb;185(2):737-43. doi: 10.1016/j.juro.2010.09.079. Epub 2010 Dec 18.

  PMID: 21168860 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Underactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Cindy Amundsen, MD
• Organization: Duke University Medical Center

cindy.amundsen@duke.edu

919-401-1000

Study Officials

• Cindy L Amundsen, MD

  Duke University

  STUDY CHAIR

• Em Abbott, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 18, 2020
• Study Start: September 1, 2021
• Primary Completion: September 4, 2024
• Study Completion: September 27, 2024
• Last Updated: July 16, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)