An interventional study of prolotherapy in Overactive Bladder and Underactive Bladder, sponsored by Taichung Armed Forces General Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-08-29.
Sponsored by Taichung Armed Forces General Hospital · Not applicable, Interventional, and Treatment
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.
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.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 80 is above the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Taichung Armed Forces General Hospital is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Overactive bladder
Procedure: prolotherapy
Underactive bladder
Procedure: prolotherapy
5% glucose 10ml local injection peripheral to posterior tibial nerve near ankle under ultrasound guidance once a week for 4 weeks.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week16
Cystometric bladder capacity
Cystometric bladder capacity: the volume of water instilled into bladder while performing cystometry examination.
Time frame: Week0
Cystometric bladder capacity
Cystometric bladder capacity: the volume of water instilled into bladder while performing cystometry examination.
Time frame: Week4
Cystometric bladder capacity
Cystometric bladder capacity: the volume of water instilled into bladder while performing cystometry examination.
Time frame: Week16
The improvement of Patient Perception of Bladder Condition (PPBC)
The PPBC measures the patients' perception of their urinary (bladder) problems. Ranged from 1 to 6. The core 1 means no bother from bladder condition, higher score means more bother form bladder condition.
Time frame: Week 0
The improvement of Patient Perception of Bladder Condition
The PPBC measures the patients' perception of their urinary (bladder) problems. Ranged from 1 to 6. The core 1 means no bother from bladder condition, higher score means more bother form bladder condition.
Time frame: Week1
The improvement of Patient Perception of Bladder Condition
The PPBC measures the patients' perception of their urinary (bladder) problems. Ranged from 1 to 6. The core 1 means no bother from bladder condition, higher score means more bother form bladder condition.
Time frame: Week2
The improvement of Patient Perception of Bladder Condition
The PPBC measures the patients' perception of their urinary (bladder) problems. Ranged from 1 to 6. The core 1 means no bother from bladder condition, higher score means more bother form bladder condition.
Time frame: Week3
The improvement of Patient Perception of Bladder Condition
The PPBC measures the patients' perception of their urinary (bladder) problems. Ranged from 1 to 6. The core 1 means no bother from bladder condition, higher score means more bother form bladder condition.
Time frame: Week4
The improvement of Patient Perception of Bladder Condition
The PPBC measures the patients' perception of their urinary (bladder) problems.
Time frame: Week8
The improvement of Patient Perception of Bladder Condition
The PPBC measures the patients' perception of their urinary (bladder) problems. Ranged from 1 to 6. The core 1 means no bother from bladder condition, higher score means more bother form bladder condition.
Time frame: Week12
The improvement of Patient Perception of Bladder Condition
The PPBC measures the patients' perception of their urinary (bladder) problems. Range from 1 to 6. The core 1 means no bother from bladder condition, higher score means more bother form bladder condition.
Time frame: Week16
Plan to share: No
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Taichung Armed Forces General Hospital