Clinical trial NCT05485142: The Treatment Efficacy of Prolotherapy in Bladder Voiding Dysfunction
Official title: The Treatment Efficacy of Prolotherapy in Bladder Voiding Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overactive Bladder
Underactive Bladder
Keywords: neural prolotherapy
detrusor underactivity
overactive bladder
Lead sponsor: Taichung Armed Forces General Hospital
Sponsor class: OTHER_GOV
First posted: 2022-08-03
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overactive Bladder Symptom Score
timeFrame: Week 0
measure: Overactive Bladder Symptom Score
timeFrame: Week1
measure: Overactive Bladder Symptom Score
timeFrame: Week2
measure: Overactive Bladder Symptom Score
timeFrame: Week3
measure: Overactive Bladder Symptom Score
timeFrame: Week4
measure: Overactive Bladder Symptom Score
timeFrame: Week8
measure: Overactive Bladder Symptom Score
timeFrame: Week12
measure: Overactive Bladder Symptom Score
timeFrame: Week16
Secondary outcomes:
measure: Cystometric bladder capacity
timeFrame: Week0
measure: Cystometric bladder capacity
timeFrame: Week4
measure: Cystometric bladder capacity
timeFrame: Week16
Other outcomes:
measure: The improvement of Patient Perception of Bladder Condition (PPBC)
timeFrame: Week 0
measure: The improvement of Patient Perception of Bladder Condition
timeFrame: Week1
measure: The improvement of Patient Perception of Bladder Condition
timeFrame: Week2
measure: The improvement of Patient Perception of Bladder Condition
timeFrame: Week3
measure: The improvement of Patient Perception of Bladder Condition
timeFrame: Week4
measure: The improvement of Patient Perception of Bladder Condition
timeFrame: Week8
measure: The improvement of Patient Perception of Bladder Condition
timeFrame: Week12
measure: The improvement of Patient Perception of Bladder Condition
timeFrame: Week16
Locations:
city: Taichung
country: Taiwan
facility: Taichung Armed Forces General Hospital
state: Other (Non US)
Study officials:
affiliation: Taichung Armed Forces General Hospital
name: Jing-dung Shen
role: PRINCIPAL_INVESTIGATOR
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