UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057144 |
|---|---|
| Receipt number | R000065293 |
| Scientific Title | A Study on Overactive Bladder and Stress Urinary Incontinence Before and After Robot-Assisted Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse |
| Date of disclosure of the study information | 2025/02/27 |
| Last modified on | 2025/07/30 15:04:33 |
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Basic information
Public title
A Study on Overactive Bladder and Stress Urinary Incontinence Before and After Robot-Assisted Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse
Acronym
A Study on Overactive Bladder and Stress Urinary Incontinence Before and After Robot-Assisted Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse
Scientific Title
A Study on Overactive Bladder and Stress Urinary Incontinence Before and After Robot-Assisted Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse
Scientific Title:Acronym
A Study on Overactive Bladder and Stress Urinary Incontinence Before and After Robot-Assisted Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse
Region
| Japan |
Condition
Condition
Pelvic Organ Prolapse
Classification by specialty
| Obstetrics and Gynecology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of overactive bladder and tress urinary incontinence before and afterlaparoscopic sacrocolpopexy and robotic-assisted sacrocolpopexy , comparing the effects of these surgical methods on lower urinary tract symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overactive Bladder Symptom Score measured preoperatively and six months postoperatively
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
From April 2022 to March 2023, women with Pelvic Organ Prolapse who underwent robot-assisted laparoscopic sacral colpopexy or laparoscopic sacral colpopexy at the Department of Urogynecology, Kameda Medical Center.
Key exclusion criteria
N/A
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Tomoka |
| Middle name | |
| Last name | Obuchi |
Organization
Kameda Medical Center
Division name
Department of Urogynecology
Zip code
296-8602
Address
929 Higashicho, Kamogawa City, Chiba
TEL
04-7092-2211
tomokaobuchi@gmail.com
Public contact
Name of contact person
| 1st name | Tomoka |
| Middle name | |
| Last name | Obuchi |
Organization
Kameda Medical Center
Division name
Urogynecology
Zip code
296-8602
Address
929 Higashicho, Kamogawa City, Chiba
TEL
04-7092-2211
Homepage URL
tomokaobuchi@gmail.com
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Masayoshi Nomura
Funding Source
Organization
N/A
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
the Clinical Research Review Committee of Kameda Medical Center
Address
929 Higashicho, Kamogawa City, Chiba
Tel
04-7092-2211
tomokaobuchi@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
No. 21-123
Org. issuing International ID_1
the Clinical Research Review Committee of Kameda Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
亀田総合病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00192-025-06230-x
Number of participants that the trial has enrolled
398
Results
We demonstrated that there were no significant differences in the frequency of OAB and SUI development or improvement between the patients who underwent RSC or LSC. Postoperative follow-up is critical as both surgical methods often improve OAB but negative impact on SUI in absence of concomitant SUI procedure.
Results date posted
| 2025 | Year | 02 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 07 | Month | 29 | Day |
Baseline Characteristics
A retrospective analysis was performed for patients who underwent LSC or RSC for POP (294 LSC and 104 RSC cases) at a single general hospital in Japan from 2022 to 2023.
Participant flow
Preoperative and 6-month postoperative OAB and SUI prevalences were determined based on the OAB symptom scores and International Consultation on Incontinence Questionnaire-Short Form. Changes in the prevalence of OAB and SUI before and after surgery were examined within and between the RSC and LSC groups.
Adverse events
N/A
Outcome measures
age at the time of surgery, Body Mass Index (BMI), POP-Q stage as defined by the Preoperative Pelvic Organ Prolapse Quantification System (POP-Q), history of hysterectomy, history of abdominal surgery, surgical outcomes of RSC and LSC (operative time [min], intraoperative blood loss mL), perioperative complications occurring within six months postoperatively), Overactive Bladder Symptom Score (OABSS) measured preoperatively and six months postoperatively, and responses to the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) .
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: This is a single-center retrospective observational study. An opt-out policy was adopted for the use of existing data.
Management information
Registered date
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065293
