The Treatment Efficacy of Prolotherapy in Bladder Voiding Dysfunction

NCT05485142 | Unknown

• 1 other identifier: 108B01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Voiding dysfunction including overactive bladder, underactive bladder, and neuropathic bladder. Voiding dysfunction has a great impact on life quality, especially in the elderly society. The current medication for overactive bladder has limited efficacy and the patient easily to dropout the medication because of its side-effects. The underactive bladder is a new entity of voiding dysfunction, its optimal is still unknown. Sacral neuromodulation(SNM) and posterior tibial nerve stimulation(PTNS) have been applied for both overactive bladder and underactive bladder treatment and the results is promising, but the equipment of SNM or PTNS is not available in most places. Prolotherapy using glucose local injection causing inflammatory reaction to stimulate cytokine and growth factors release. Investigators combined the concepts of posterior tibial nerve stimulation and prolotherapy to treat voiding dysfunction. Investigators anticipate it maybe a new promising treatment for voiding dysfunction.

Conditions

Overactive Bladder; Underactive Bladder

Keywords

neural prolotherapy; detrusor underactivity; overactive bladder

Outcome Measures

Primary Outcomes (8)

• Overactive Bladder Symptom Score

  The improvement of overactive bladder symptom score (OABSS), OABSS ranged from 0 to 15, the higher score means more severity of overactive bladder.

  Week 0

• Overactive Bladder Symptom Score

  The improvement of overactive bladder symptom score (OABSS), OABSS ranged from 0 to 15, the higher score means more severity of overactive bladder.

  Week1

• Overactive Bladder Symptom Score

  The improvement of overactive bladder symptom score (OABSS), OABSS ranged from 0 to 15, the higher score means more severity of overactive bladder.

  Week2

• Overactive Bladder Symptom Score

  The improvement of overactive bladder symptom score (OABSS), OABSS ranged from 0 to 15, the higher score means more severity of overactive bladder.

  Week3

• Overactive Bladder Symptom Score

  The improvement of overactive bladder symptom score (OABSS), OABSS ranged from 0 to 15, the higher score means more severity of overactive bladder.

  Week4

• Overactive Bladder Symptom Score

  The improvement of overactive bladder symptom score (OABSS), OABSS ranged from 0 to 15, the higher score means more severity of overactive bladder.

  Week8

• Overactive Bladder Symptom Score

  The improvement of overactive bladder symptom score (OABSS), OABSS ranged from 0 to 15, the higher score means more severity of overactive bladder.

  Week12

• Overactive Bladder Symptom Score

  The improvement of overactive bladder symptom score (OABSS), OABSS ranged from 0 to 15, the higher score means more severity of overactive bladder.

  Week16

Secondary Outcomes (3)

• Cystometric bladder capacity

  Week0

• Cystometric bladder capacity

  Week4

• Cystometric bladder capacity

  Week16

Other Outcomes (8)

• The improvement of Patient Perception of Bladder Condition (PPBC)

  Week 0

• The improvement of Patient Perception of Bladder Condition

  Week1

• The improvement of Patient Perception of Bladder Condition

  Week2

Study Arms (2)

overactive bladder

EXPERIMENTAL

Overactive bladder

Procedure: prolotherapy

Underactive bladder

EXPERIMENTAL

Underactive bladder

Procedure: prolotherapy

Interventions

prolotherapy PROCEDURE

5% glucose 10ml local injection peripheral to posterior tibial nerve near ankle under ultrasound guidance once a week for 4 weeks.

Underactive bladder; overactive bladder

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 20 years-old.
• The patient who meets the diagnostic criteria of overactive bladder or underactive bladder.
• The patient who capable to complete 3-days voiding diary and the questionnaire.

You may not qualify if:

• Severe stress urinary incontinence or severe pelvic organ prolapse.
• Acute urinary tract infection.
• Active hematuria, urolithiasis, or neoplasm of urinary tract.
• Acute skin lesion over the ankle injection site or the patient who could not tolerate ankle injection.
• Pregnant women.

Sponsors & Collaborators

• Taichung Armed Forces General Hospital: lead

Study Sites (1)

Taichung Armed Forces General Hospital

Taichung, Other (Non US), 41168, Taiwan

RECRUITING

Related Publications (13)

• 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 RESULT

• Gormley EA, Lightner DJ, Faraday M, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. J Urol. 2015 May;193(5):1572-80. doi: 10.1016/j.juro.2015.01.087. Epub 2015 Jan 23.

  PMID: 25623739 RESULT

• Kaptchuk TJ. Acupuncture: theory, efficacy, and practice. Ann Intern Med. 2002 Mar 5;136(5):374-83. doi: 10.7326/0003-4819-136-5-200203050-00010.

  PMID: 11874310 RESULT

• Abraham TS, Chen ML, Ma SX. TRPV1 expression in acupuncture points: response to electroacupuncture stimulation. J Chem Neuroanat. 2011 Apr;41(3):129-36. doi: 10.1016/j.jchemneu.2011.01.001. Epub 2011 Jan 20.

  PMID: 21256210 RESULT

• Chen HC, Chen MY, Hsieh CL, Wu SY, Hsu HC, Lin YW. TRPV1 is a Responding Channel for Acupuncture Manipulation in Mice Peripheral and Central Nerve System. Cell Physiol Biochem. 2018;49(5):1813-1824. doi: 10.1159/000493627. Epub 2018 Sep 19.

  PMID: 30231245 RESULT

• Zhang T, Yu J, Huang Z, Wang G, Zhang R. Electroacupuncture improves neurogenic bladder dysfunction through activation of NGF/TrkA signaling in a rat model. J Cell Biochem. 2019 Jun;120(6):9900-9905. doi: 10.1002/jcb.28272. Epub 2018 Dec 28.

  PMID: 30592331 RESULT

• Zhao Y, Zhou J, Mo Q, Wang Y, Yu J, Liu Z. Acupuncture for adults with overactive bladder: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Feb;97(8):e9838. doi: 10.1097/MD.0000000000009838.

  PMID: 29465566 RESULT

• MacDiarmid SA, Peters KM, Shobeiri SA, Wooldridge LS, Rovner ES, Leong FC, Siegel SW, Tate SB, Feagins BA. Long-term durability of percutaneous tibial nerve stimulation for the treatment of overactive bladder. J Urol. 2010 Jan;183(1):234-40. doi: 10.1016/j.juro.2009.08.160.

  PMID: 19913821 RESULT

• Sakura S, Chan VW, Ciriales R, Drasner K. The addition of 7.5% glucose does not alter the neurotoxicity of 5% lidocaine administered intrathecally in the rat. Anesthesiology. 1995 Jan;82(1):236-40. doi: 10.1097/00000542-199501000-00028.

  PMID: 7832306 RESULT

• Tsui BC, Kropelin B, Ganapathy S, Finucane B. Dextrose 5% in water: fluid medium for maintaining electrical stimulation of peripheral nerves during stimulating catheter placement. Acta Anaesthesiol Scand. 2005 Nov;49(10):1562-5. doi: 10.1111/j.1399-6576.2005.00736.x.

  PMID: 16223407 RESULT

• Tsui BCH, Kropelin B. The electrophysiological effect of dextrose 5% in water on single-shot peripheral nerve stimulation. Anesth Analg. 2005 Jun;100(6):1837-1839. doi: 10.1213/01.ANE.0000153020.84780.A5.

  PMID: 15920223 RESULT

• Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.

  PMID: 28778254 RESULT

• Peters KM, Carrico DJ, Perez-Marrero RA, Khan AU, Wooldridge LS, Davis GL, Macdiarmid SA. Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010 Apr;183(4):1438-43. doi: 10.1016/j.juro.2009.12.036. Epub 2010 Feb 20.

  PMID: 20171677 RESULT

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Bladder, Underactive

Interventions

Prolotherapy

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jing-dung Shen

  Taichung Armed Forces General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing-dung Shen, MD

CONTACT

+886958878129; jdwhydo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Urologist

Study Record Dates

• First Submitted: July 17, 2022
• First Posted: August 3, 2022
• Study Start: May 1, 2019
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)