The Treatment Efficacy of Prolotherapy in Bladder Voiding Dysfunction

Taichung Armed Forces General Hospital

Status: Enrolling

Conditions: Underactive Bladder; Overactive Bladder

Treatments: Procedure: prolotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05485142

108B01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

overactive bladder

Experimental group

Description:

Overactive bladder

Treatment:

Procedure: prolotherapy

Underactive bladder

Experimental group

Description:

Underactive bladder

Treatment:

Procedure: prolotherapy