The Treatment Efficacy of Prolotherapy in Bladder Voiding Dysfunction
Primary Purpose
Overactive Bladder, Underactive Bladder
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
prolotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring neural prolotherapy, detrusor underactivity, overactive bladder
Eligibility Criteria
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.
Sites / Locations
- Taichung Armed Forces General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
overactive bladder
Underactive bladder
Arm Description
Overactive bladder
Underactive bladder
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Cystometric bladder capacity
Cystometric bladder capacity: the volume of water instilled into bladder while performing cystometry examination.
Cystometric bladder capacity
Cystometric bladder capacity: the volume of water instilled into bladder while performing cystometry examination.
Cystometric bladder capacity
Cystometric bladder capacity: the volume of water instilled into bladder while performing cystometry examination.
Full Information
NCT ID
NCT05485142
First Posted
July 17, 2022
Last Updated
August 27, 2023
Sponsor
Taichung Armed Forces General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05485142
Brief Title
The Treatment Efficacy of Prolotherapy in Bladder Voiding Dysfunction
Official Title
The Treatment Efficacy of Prolotherapy in Bladder Voiding Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taichung Armed Forces General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Underactive Bladder
Keywords
neural prolotherapy, detrusor underactivity, overactive bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
overactive bladder
Arm Type
Experimental
Arm Description
Overactive bladder
Arm Title
Underactive bladder
Arm Type
Experimental
Arm Description
Underactive bladder
Intervention Type
Procedure
Intervention Name(s)
prolotherapy
Intervention Description
5% glucose 10ml local injection peripheral to posterior tibial nerve near ankle under ultrasound guidance once a week for 4 weeks.
Primary Outcome Measure Information:
Title
Overactive Bladder Symptom Score
Description
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
Title
Overactive Bladder Symptom Score
Description
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
Title
Overactive Bladder Symptom Score
Description
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
Title
Overactive Bladder Symptom Score
Description
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
Title
Overactive Bladder Symptom Score
Description
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
Title
Overactive Bladder Symptom Score
Description
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
Title
Overactive Bladder Symptom Score
Description
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
Title
Overactive Bladder Symptom Score
Description
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
Secondary Outcome Measure Information:
Title
Cystometric bladder capacity
Description
Cystometric bladder capacity: the volume of water instilled into bladder while performing cystometry examination.
Time Frame
Week0
Title
Cystometric bladder capacity
Description
Cystometric bladder capacity: the volume of water instilled into bladder while performing cystometry examination.
Time Frame
Week4
Title
Cystometric bladder capacity
Description
Cystometric bladder capacity: the volume of water instilled into bladder while performing cystometry examination.
Time Frame
Week16
Other Pre-specified Outcome Measures:
Title
The improvement of Patient Perception of Bladder Condition (PPBC)
Description
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
Title
The improvement of Patient Perception of Bladder Condition
Description
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
Title
The improvement of Patient Perception of Bladder Condition
Description
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
Title
The improvement of Patient Perception of Bladder Condition
Description
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
Title
The improvement of Patient Perception of Bladder Condition
Description
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
Title
The improvement of Patient Perception of Bladder Condition
Description
The PPBC measures the patients' perception of their urinary (bladder) problems.
Time Frame
Week8
Title
The improvement of Patient Perception of Bladder Condition
Description
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
Title
The improvement of Patient Perception of Bladder Condition
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing-dung Shen, MD
Phone
+886958878129
Email
jdwhydo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing-dung Shen
Organizational Affiliation
Taichung Armed Forces General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung Armed Forces General Hospital
City
Taichung
State/Province
Other (Non US)
ZIP/Postal Code
41168
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing-dung Shen, MD
Phone
+886958878129
Email
jdwhydo@gmail.com
First Name & Middle Initial & Last Name & Degree
Jing-dung Shen, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Learn more about this trial
The Treatment Efficacy of Prolotherapy in Bladder Voiding Dysfunction
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