The Treatment Efficacy of Prolotherapy in Bladder Voiding Dysfunction

NCT ID: NCT05485142

Last Updated: 2023-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Inclusion criteria:1. Adults over 20 years-old. 2. The patient who meets the diagnostic criteria of overactive bladder or underactive bladder. 3. The patient who capable to complete 3-days voiding diary and the questionnaire. Exclusion criteria: 1. The patient has severe stress urinary incontinence, severe pelvic organ prolapse, acute urinary tract infection, urolithiasis, or urinary tract malignancy. 2. The patient who has active skin disease on legs or not suitable for leg local injection. 3. Pregnant women. Method: 40 overactive bladder patients and 40 underactive bladder patients. The patients will receive 5% glucose 10ml local injection peripheral to posterior tibial nerve near ankle under ultrasound guidance once a week for 4 weeks, then the patients will be followed up once-a-month for 3 months. OverActive Bladder Symptom Score(OABSS), Core Lower Urinary Tract Symptom score(CLSS) questionnaire, 3-days voiding diary, and urine nerve growth factor are used for assessment.

Conditions

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Overactive Bladder Underactive Bladder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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overactive bladder

Overactive bladder

Group Type EXPERIMENTAL

prolotherapy

Intervention Type PROCEDURE

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

Underactive bladder

Underactive bladder

Group Type EXPERIMENTAL

prolotherapy

Intervention Type PROCEDURE

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

Interventions

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prolotherapy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Severe stress urinary incontinence or severe pelvic organ prolapse.
2. Acute urinary tract infection.
3. Active hematuria, urolithiasis, or neoplasm of urinary tract.
4. Acute skin lesion over the ankle injection site or the patient who could not tolerate ankle injection.
5. Pregnant women.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Armed Forces General Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jing-Dung, SHEN

Senior Urologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jing-dung Shen

Role: PRINCIPAL_INVESTIGATOR

Taichung Armed Forces General Hospital

Locations

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Taichung Armed Forces General Hospital

Taichung, Other (Non US), Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jing-dung Shen, MD

Role: CONTACT

+886958878129

Facility Contacts

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Jing-dung Shen, MD

Role: primary

+886958878129

References

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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.

Reference Type RESULT
PMID: 18490916 (View on PubMed)

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.

Reference Type RESULT
PMID: 25623739 (View on PubMed)

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.

Reference Type RESULT
PMID: 11874310 (View on PubMed)

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.

Reference Type RESULT
PMID: 21256210 (View on PubMed)

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.

Reference Type RESULT
PMID: 30231245 (View on PubMed)

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.

Reference Type RESULT
PMID: 30592331 (View on PubMed)

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.

Reference Type RESULT
PMID: 29465566 (View on PubMed)

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.

Reference Type RESULT
PMID: 19913821 (View on PubMed)

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.

Reference Type RESULT
PMID: 7832306 (View on PubMed)

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.

Reference Type RESULT
PMID: 16223407 (View on PubMed)

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.

Reference Type RESULT
PMID: 15920223 (View on PubMed)

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.

Reference Type RESULT
PMID: 28778254 (View on PubMed)

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.

Reference Type RESULT
PMID: 20171677 (View on PubMed)

Other Identifiers

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108B01

Identifier Type: -

Identifier Source: org_study_id

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