Pelvic Organ ProlapseNCT04416152
Impact of Female Pelvic Reconstruction Surgery on Lower Urinary Tract Symptoms, Psychosomatic Distress and Sexual Function
An observational study of Pelvic Organ Prolapse, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To get the impact of pelvic floor reconstruction surgery on lower urinary tract symptoms, psychological distress and sexual function. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Pelvic reconstruction surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 May 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with pelvic organ prolapse, who will undergo or had undergo pelvic reconstruction surgeries.
Who may be able to join
- Women with pelvic organ prolapse, who will undergo pelvic reconstruction surgery
- Women who had undergone pelvic reconstruction surgeries in our hospital
Who cannot join
- Pregnant woman.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
Sheng-Mou Hsiao, M.D., +886-2-89667000 ext. 1818, smhsiao2@gmail.com
About this study
To get the impact of pelvic floor reconstruction surgery on lower urinary tract symptoms, psychological distress and sexual function.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Pelvic reconstruction surgery
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic reconstruction surgeryProcedure or surgery
Pelvic reconstruction surgeries, such as anterior/posterior colporrhaphy, sacrospinous ligament fixation, transvaginal mesh repair and sacrocolpopexy.
What is being measured
The primary outcome is the main question the study is designed to answer.
the women's bladder function questionnaire of UDI-6
Change of UDI-6 score between baseline and after pelvic reconstruction surgery. Score values 0-18, and higher scores mean a or worse outcome.
Measured: 10 years
the women's bladder function questionnaire of IIQ-7
Change of IIQ-7 score between baseline and after pelvic reconstruction surgery. Score values 0-18, and higher scores mean a or worse outcome.
Measured: 10 years
Change of psychosomatic score
Change of psychosomatic score between baseline and after pelvic reconstruction surgery, and higher scores mean a or worse outcome.
Measured: 1 year
Change of Overactive Bladder Symptom Score
Change of OABSS score between baseline and after pelvic reconstruction surgery. Score values 0-15, and higher scores mean a or worse outcome.
Measured: 1 year
Change of FSFI score
Change of FSFI score between baseline and after pelvic reconstruction surgery. higher scores mean a or worse outcome.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start26 May 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416152
- Sponsor's protocol ID
- 109045-F
- Status last verified
- Sep 2023
- First submitted
- 1 Jun 2020
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Female Pelvic Reconstruction Surgery on Lower Urinary Tract Symptoms, Psychosomatic Distress and Sexual Function
- ClinicalTrials.gov ID
- NCT04416152
- Acronym / sponsor ID
- 109045-F
- Conditions
- Pelvic Organ Prolapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 26 May 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To get the impact of pelvic floor reconstruction surgery on lower urinary tract symptoms, psychological distress and sexual function.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with pelvic organ prolapse, who will undergo or had undergo pelvic reconstruction surgeries.
Key inclusion criteria (2 listed)
- Women with pelvic organ prolapse, who will undergo pelvic reconstruction surgery
- Women who had undergone pelvic reconstruction surgeries in our hospital
Key exclusion criteria (1 listed)
- Pregnant woman.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic reconstruction surgeryPelvic reconstruction surgeries, such as anterior/posterior colporrhaphy, sacrospinous ligament fixation, transvaginal mesh repair and sacrocolpopexy. | Procedure or surgery | – |
Primary outcome
the women's bladder function questionnaire of UDI-6
Time frame: 10 years
Change of UDI-6 score between baseline and after pelvic reconstruction surgery. Score values 0-18, and higher scores mean a or worse outcome.
the women's bladder function questionnaire of IIQ-7
Time frame: 10 years
Change of IIQ-7 score between baseline and after pelvic reconstruction surgery. Score values 0-18, and higher scores mean a or worse outcome.
Change of psychosomatic score
Time frame: 1 year
Change of psychosomatic score between baseline and after pelvic reconstruction surgery, and higher scores mean a or worse outcome.
Change of Overactive Bladder Symptom Score
Time frame: 1 year
Change of OABSS score between baseline and after pelvic reconstruction surgery. Score values 0-15, and higher scores mean a or worse outcome.
Change of FSFI score
Time frame: 1 year
Change of FSFI score between baseline and after pelvic reconstruction surgery. higher scores mean a or worse outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng-Mou Hsiao, MD (+886289667000 ext. 1818, smhsiao2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the women's bladder function questionnaire of UDI-6 (time frame: 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.