UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027741 |
|---|---|
| Receipt number | R000031783 |
| Scientific Title | Safety and efficacy of ablative fractional CO2 laser thrapy for external genital and the vagina in women with lower urinary tract symptom |
| Date of disclosure of the study information | 2017/06/13 |
| Last modified on | 2021/06/16 11:28:23 |
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Basic information
Public title
Safety and efficacy of ablative fractional CO2 laser thrapy for external genital and the vagina in women with lower urinary tract symptom
Acronym
AFLT study for LUTS
Scientific Title
Safety and efficacy of ablative fractional CO2 laser thrapy for external genital and the vagina in women with lower urinary tract symptom
Scientific Title:Acronym
AFLT study for LUTS
Region
| Japan |
Condition
Condition
Over active bladder syndrome and stress urinary incontinence
Classification by specialty
| Obstetrics and Gynecology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety of AFLT and efficacy for OAB/SUI synptoms
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effect of AFLT at pre, 3 months, half a year and one year by urinary diary
Key secondary outcomes
Effect of AFLT at pre, 3 months, half a year and one year by questionnaire and objective evaluation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
ablative fractional laser therapy by Smarttxide2
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
OAB and/or SUI patients who want to evade operation or medecal treatment
Key exclusion criteria
1) heart disease
2) severely lung disease
3) neurogenic bladder syndrome
4) pelvic organ prolapse (more than 3)
5) pragnancy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Ninomiya |
Organization
Women Clinic LUNA SHINSAIBASHI
Division name
Urology
Zip code
5420086
Address
1-13-21 Nishi-shinsaibashi Chuoh-ku Osaka
TEL
0662517505
ninomiya5829@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Ninomiya |
Organization
Women Clinic LUNA SHINSAIBASHI
Division name
Urology
Zip code
5420086
Address
1-13-21 Nishi-shinsaibashi Chuoh-ku Osaka
TEL
0662517505
Homepage URL
ninomiya5829@yahoo.co.jp
Sponsor or person
Institute
Medical corporation LEADING GIRLS
Institute
Department
Personal name
Funding Source
Organization
DEKA Japan co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
DEKA Japan co.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical corporation LEADING GIRLS
Address
2-96 motomachi naka-ku Yokohama city
Tel
045-680-1226
luna.makiskgc@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 13 | Day |
Related information
URL releasing protocol
no
Publication of results
Unpublished
Result
URL related to results and publications
no
Number of participants that the trial has enrolled
19
Results
Significant improvement in vaginal withdrawal was observed in the treated patients.
Of the 19 participants, 9 patients without incontinence and 10 patients with incontinence were divided into the analysis.
The vaginal health index improved significantly in patients without incontinence. Patients with incontinence tended to improve.
Many patients with incontinence improved their OABSS scores compared to patients without incontinence (no significant difference).
Results date posted
| 2021 | Year | 06 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the patients with LUTS symptoms who complained that anticholinergic agents and b3 agonists were inadequate during outpatient visits to our hospital, 19 patients who had GSM on pelvic examination findings
Participant flow
Therapeutic device DEKA Smart Side Square
Percutaneous anesthesia to the vulva (about 10 minutes)
Laser irradiation of the vagina, vestibule including urethra, and labia minora (procedure name; Mona Lisa Touch)
3 times in total every 4 weeks
Adverse events
Irradiation pain, vaginitis
Outcome measures
Vaginal Decay, Vaginal Health Index (VHS)
ICIQ-SF / OABSS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
nothing
Management information
Registered date
| 2017 | Year | 06 | Month | 13 | Day |
Last modified on
| 2021 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031783
