UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	ninomiya5829@yahoo.co.jp

Sponsor
Institute	Medical corporation LEADING GIRLS
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031783