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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043845
Receipt No. R000050032
Scientific Title Clinical and urodynamic study in pelvic organ prolapse patients perioperative laparoscopic sacrocolpopexy: A prospective study
Date of disclosure of the study information 2021/05/01
Last modified on 2021/04/05

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Basic information
Public title Clinical and urodynamic study in pelvic organ prolapse patients perioperative laparoscopic sacrocolpopexy A prospective study
Acronym Evaluation of urinary incontinence in perioperative laparoscopic sacrocolpopexy
Scientific Title Clinical and urodynamic study in pelvic organ prolapse patients perioperative laparoscopic sacrocolpopexy: A prospective study
Scientific Title:Acronym Evaluation of urinary incontinence in perioperative laparoscopic sacrocolpopexy
Region
Japan

Condition
Condition Pelvic organ prolapse
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clinical and urodynamic evaluation in patients with incontinence of pelvic organ prolapse
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes The primary objective of this study was to evaluate the patient-reported urinary incontinence perioperative laparoscopic sacrocolpopexy.
Key secondary outcomes The secondary objective was to compare urodynamic study parameters perioperative laparoscopic sacrocolpopexy.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 We evaluate perioperative incontinence for pelvic organ prolapse with incontinence by urodynamic study.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria POP with incontinence patients are included more than POP-Q stage 2 in this study. Informed consent was obtained from all study participants.
Key exclusion criteria Those who underwent a simultaneous anti-incontinence procedure were excluded. Those who prescribe for antimuscarinics and beta 3-adrenoreceptor agonist during perioperative surgery. Those who are supposed to be
inadequate to enroll this study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hirotaka
Middle name
Last name Sato
Organization Hokusuikai Kinen Hospital
Division name Department of Urology
Zip code 3100852
Address 3-2-1, Higashihara-cyo, Mito-city, Ibaraki-ken
TEL 0293033003
Email hirotakasato911@yahoo.co.jp

Public contact
Name of contact person
1st name Hirotaka
Middle name
Last name Sato
Organization Hokusuikai Kinen Hospital
Division name Department of Urology
Zip code 3100035
Address 3-2-1, Higashiharacyou, mitocity, Ibarakiken
TEL 0293033003
Homepage URL
Email hirotakasato911@yahoo.co.jp

Sponsor
Institute Department of Urology, Hokusuikai Kinen Hospital
Institute
Department

Funding Source
Organization Department of Urology, Hokusuikai Kinen Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hokusuikai Kinen Hospital
Address 3-2-1, Higashihara-cyo, Mito-city, Ibaraki-ken
Tel 0293033003
Email hirotakasato911@yahoo.co.jp

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
2021 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2021 Year 03 Month 01 Day
Date of IRB
2020 Year 12 Month 24 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2023 Year 05 Month 31 Day
Date of closure to data entry
2024 Year 05 Month 31 Day
Date trial data considered complete
2024 Year 05 Month 31 Day
Date analysis concluded
2024 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2021 Year 04 Month 05 Day
Last modified on
2021 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050032

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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