Pelvic Organ ProlapseNCT05697796
Comparison of Post-operative Symptoms After Two Surgeries for Patients With Pelvic Organ Prolapse
An observational study of Pelvic Organ Prolapse, run by Peking University People's Hospital at 1 site in China.
Trial summary
Collect and review the patients who underwent surgical treatment due to pelvic floor organ prolapse from 2020 to 2021, make statistics on their postoperative questionnaire data, and evaluate the clinical effects of different surgical methods Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Two different surgical methods
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 23 Dec 2022
- 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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients had pelvic organ prolapse receiving two specific surgical methods
Who may be able to join
- Age ≥ 30 years;
- Because pelvic organ prolapse in our hospital, we performed extraperitoneal high sacral ligament suspension or sacrospinal ligament fixation; ③ Those who have no surgical contraindication and can tolerate surgery and anesthesia.
Who cannot join
- Those who cannot tolerate surgery and anesthesia; ② Patients receiving other tip suspension techniques.
Trial locations and contacts
1 site in 1 country.
China1 site
The Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Comparison of Post-operative Lower Urinary Tract Symptoms After Sacrospinous Ligament Fixation or Extraperitoneal High Uterosacral Ligament Suspension for Patients With Pelvic Organ Prolapse
Collect and review the patients who underwent surgical treatment due to pelvic floor organ prolapse from 2020 to 2021, make statistics on their postoperative questionnaire data, and evaluate the clinical effects of different surgical methods
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Two different surgical methods
- 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.
Two different surgical methodsProcedure or surgery
SSLF：sacrospinal ligament fixation EHUS：Extraperitoneal high sacral ligament suspension
| Study group | Role | What they receive |
|---|---|---|
| patients had pelvic organ prolapse who undergone Sacrospinal ligament fixation | Not described Receives: Procedure: Two different surgical methods | |
| patients had pelvic organ prolapse who undergone Extraperitoneal high sacral ligament suspension | Not described Receives: Procedure: Two different surgical methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in POP-Q score at different time nodes
Gynecological examination
Measured: pre-operation and post-operation(1month, 3 months and 6 months )
Secondary outcomes (3)
UDI-6 scores at different time nodes
Questionnaires on lower urinary tract symptoms and quality of life
Measured: pre-operation and post-operation(1month, 3 months and 6 months )
PFDI-20 scores at different time nodes
Questionnaires on lower urinary tract symptoms and quality of life
Measured: pre-operation and post-operation(1month, 3 months and 6 months )
OABss scores at different time nodes
Questionnaires on lower urinary tract symptoms
Measured: pre-operation and post-operation(1month, 3 months and 6 months )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Nov 2022
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
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.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Xiuli, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697796
- Sponsor's protocol ID
- PKUPH8
- Status last verified
- Dec 2022
- First submitted
- 24 Dec 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-operative Lower Urinary Tract Symptoms After Sacrospinous Ligament Fixation or Extraperitoneal High Uterosacral Ligament Suspension for Patients With Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT05697796
- Acronym / sponsor ID
- PKUPH8
- Conditions
- Pelvic Organ Prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 26 Jan 2023 (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.
Collect and review the patients who underwent surgical treatment due to pelvic floor organ prolapse from 2020 to 2021, make statistics on their postoperative questionnaire data, and evaluate the clinical effects of different surgical methods
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients had pelvic organ prolapse who undergone Sacrospinal ligament fixation | – | Procedure: Two different surgical methods |
| patients had pelvic organ prolapse who undergone Extraperitoneal high sacral ligament suspension | – | Procedure: Two different surgical methods |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients had pelvic organ prolapse receiving two specific surgical methods
Key inclusion criteria (2 listed)
- Age ≥ 30 years;
Key exclusion criteria (1 listed)
- Those who cannot tolerate surgery and anesthesia; ② Patients receiving other tip suspension techniques.
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 |
|---|---|---|
| Two different surgical methodsSSLF：sacrospinal ligament fixation EHUS：Extraperitoneal high sacral ligament suspension | Procedure or surgery | patients had pelvic organ prolapse who undergone Extraperitoneal high sacral ligament suspension, patients had pelvic organ prolapse who undergone Sacrospinal ligament fixation |
Primary outcome
changes in POP-Q score at different time nodes
Time frame: pre-operation and post-operation(1month, 3 months and 6 months )
Gynecological examination
3 secondary outcomes
UDI-6 scores at different time nodes
Time frame: pre-operation and post-operation(1month, 3 months and 6 months )
PFDI-20 scores at different time nodes
Time frame: pre-operation and post-operation(1month, 3 months and 6 months )
OABss scores at different time nodes
Time frame: pre-operation and post-operation(1month, 3 months and 6 months )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: Yes
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
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i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
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Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Peking University People's Hospital at 1 site in China.
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: finished, as of the sponsor's last update on 26 Jan 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in POP-Q score at different time nodes (time frame: pre-operation and post-operation(1month, 3 months and 6 months )). 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 26 Jan 2023.