UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043845 |
|---|---|
| Receipt number | 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 | 2024/10/07 11:43:03 |
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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
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
hirotakasato911@yahoo.co.jp
Sponsor or person
Institute
Department of Urology, Hokusuikai Kinen Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Hokusuikai Kinen Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
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
| 2028 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2030 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2030 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 05 | Day |
Last modified on
| 2024 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050032
