The Treatment Efficacy of Prolotherapy in Bladder Voiding Dysfunction

Study Overview
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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.

Official Title
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The Treatment Efficacy of Prolotherapy in Bladder Voiding Dysfunction

Conditions
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Overactive Bladder, Underactive Bladder

Intervention / Treatment
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* Procedure: prolotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: overactive bladder<br>Overactive bladder | Procedure: prolotherapy<br>* 5% glucose 10ml local injection peripheral to posterior tibial nerve near ankle under ultrasound guidance once a week for 4 weeks.<br>|
| Experimental: Underactive bladder<br>Underactive bladder | Procedure: prolotherapy<br>* 5% glucose 10ml local injection peripheral to posterior tibial nerve near ankle under ultrasound guidance once a week for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cystometric bladder capacity | Cystometric bladder capacity: the volume of water instilled into bladder while performing cystometry examination. | Week0 | 
| Cystometric bladder capacity | Cystometric bladder capacity: the volume of water instilled into bladder while performing cystometry examination. | Week4 | 
| Cystometric bladder capacity | Cystometric bladder capacity: the volume of water instilled into bladder while performing cystometry examination. | Week16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neural prolotherapy, detrusor underactivity, overactive bladder