Pelvic Organ ProlapseNCT05189665
the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse
A study testing Extraperitoneal high sacral ligament suspension surgery and Sacrospinous ligament fixation in people with Pelvic Organ Prolapse, run by Peking University People's Hospital at 1 site in China.
Trial summary
The study is a prospective study at a single institution. Investigators create strict inclusion and exclusion criteria, selecting 124 patients with POP(≥II degree and have symptoms that need operation) . 62 patients in the intervention group accept extraperitoneal high uterosacral ligament suspension. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Extraperitoneal high sacral ligament suspension surgery and Sacrospinous ligament fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to Apr 2023
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥30 years old;
- pelvic organ prolapse, with or without abnormal urination or defecation or sexual disturbance, which affects the quality of life
- Pelvic organ prolapse quantitation (POP-Q) is greater than or equal to Those who are in stage II and have symptoms and require surgery
- The patient agrees to conduct the study and can be followed up on time.
Who cannot join
- Those who cannot tolerate surgery and anesthesia
- Those who need to remove the uterus
- Those who have removed the uterus
- Those who cannot be followed up on time.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
xiuli sun, professor, 010-88324354, sunxiuli03351@126.com
jiaoyang song, doctor, 010-88324354, 18846453272@163.com
About this study
Official title: A Randomized Controlled Study on the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse
The study is a prospective study at a single institution. Investigators create strict inclusion and exclusion criteria, selecting 124 patients with POP(≥II degree and have symptoms that need operation) . 62 patients in the intervention group accept extraperitoneal high uterosacral ligament suspension. The other 62 patients in the other group accept sacrospinous ligament suspension.
Read the detailed description
Investigators evaluate all women's operation method, operation time, bleed volume, overactive bladder questionnaire, PFDI-20，ICIQ-SF, I-QoL, PISQ-12, PFIQ-7, UDI-6, pre- and post-operation (at 1 month, 3 months, 6months and 1 year).
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Extraperitoneal high sacral ligament suspension surgery, Sacrospinous ligament fixation
- Keywords
- Extraperitoneal high uterosacral ligament suspension
- 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.
Extraperitoneal high sacral ligament suspension surgeryProcedure or surgery
The extraperitoneal high sacral ligament suspension surgery is to shorten the bilateral uterosacral ligaments .
Sacrospinous ligament fixationProcedure or surgery
The sacrospinous ligament fixation surgery is to open the front and back peritoneum through the vagina and shorten the bilateral uterosacral ligaments.
| Study group | Role | What they receive |
|---|---|---|
| Extraperitoneal high sacral ligament suspension Group | Experimental | We will recruit 62 POP patients ,and perform Surgery Extraperitoneal high sacral ligament suspension surgery on them. Receives: Procedure: Extraperitoneal high sacral ligament suspension surgery |
| Sacrospinous Ligament Suspension Group | Active comparator | We will recruit 62 POP patients ,and perform sacrospinous ligament suspension surgery on them. Receives: Procedure: Sacrospinous ligament fixation |
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(at 1month, 3 month, 6 month and a year)
Secondary outcomes (8)
UDI-6 scores at different time nodes UDI-6
Questionnaires on lower urinary tract symptoms and quality of life
Measured: pre-operation and post-operation(at 1month, 3 month, 6 month and a year)
Postoperative urinary incontinence assessment
One hour pad test
Measured: post-operation(at 1month, 3 month, 6 month and a year)
OABss score at different time nodes
Questionnaires lower urinary tract symptoms
Measured: post-operation(at 1month, 3 month, 6 month and a year)
PFDI-20 score at different time nodes
Questionnaires on pelvic floor function and lower urinary tract symptoms and quality of life
Measured: post-operation(at 1month, 3 month, 6 month and a year)
ICIQ-SF score at different time nodes
Questionnaires on lower urinary tract symptoms
Measured: post-operation(at 1month, 3 month, 6 month and a year)
I-QoL score at different time nodes
Questionnaires on lower urinary tract symptoms and quality of life
Measured: post-operation(at 1month, 3 month, 6 month and a year)
PISQ-12 score at different time nodes
Questionnaires on pelvic floor function and lower urinary tract symptoms and sexual quality of life
Measured: post-operation(at 1month, 3 month, 6 month and a year)
PFIQ-7 score at different time nodes
Questionnaires on pelvic floor function and quality of life
Measured: post-operation(at 1month, 3 month, 6 month and a year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Oct 2021
- Primary completionDec 2022 (estimated)
- Study completionApr 2023 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
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
- Investigators
- xiuli sun, professor, Study chair, Beijing Key Laboratory of Female Pelvic Floor Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189665
- Sponsor's protocol ID
- Pkuh4
- Status last verified
- Oct 2021
- First submitted
- 23 Nov 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Extraperitoneal high uterosacral ligament sling is effective in treating pelvic organ prolapse, and postoperative anatomical recovery is good, not inferior to traditional sacral ligament sling
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT05189665
- Acronym / sponsor ID
- Pkuh4
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Extraperitoneal high uterosacral ligament suspension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 12 Jan 2022 (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.
The study is a prospective study at a single institution. Investigators create strict inclusion and exclusion criteria, selecting 124 patients with POP(≥II degree and have symptoms that need operation) . 62 patients in the intervention group accept extraperitoneal high uterosacral ligament suspension. The other 62 patients in the other group accept sacrospinous ligament suspension.
Detailed description
Investigators evaluate all women's operation method, operation time, bleed volume, overactive bladder questionnaire, PFDI-20，ICIQ-SF, I-QoL, PISQ-12, PFIQ-7, UDI-6, pre- and post-operation (at 1 month, 3 months, 6months and 1 year).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extraperitoneal high sacral ligament suspension Group | Experimental | Procedure: Extraperitoneal high sacral ligament suspension surgeryWe will recruit 62 POP patients ,and perform Surgery Extraperitoneal high sacral ligament suspension surgery on them. |
| Sacrospinous Ligament Suspension Group | Active comparator | Procedure: Sacrospinous ligament fixationWe will recruit 62 POP patients ,and perform sacrospinous ligament suspension surgery on them. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥30 years old;
- pelvic organ prolapse, with or without abnormal urination or defecation or sexual disturbance, which affects the quality of life
- Pelvic organ prolapse quantitation (POP-Q) is greater than or equal to Those who are in stage II and have symptoms and require surgery
- The patient agrees to conduct the study and can be followed up on time.
Key exclusion criteria (4 listed)
- Those who cannot tolerate surgery and anesthesia
- Those who need to remove the uterus
- Those who have removed the uterus
- Those who cannot be followed up on time.
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 |
|---|---|---|
| Extraperitoneal high sacral ligament suspension surgeryThe extraperitoneal high sacral ligament suspension surgery is to shorten the bilateral uterosacral ligaments . | Procedure or surgery | Extraperitoneal high sacral ligament suspension Group |
| Sacrospinous ligament fixationThe sacrospinous ligament fixation surgery is to open the front and back peritoneum through the vagina and shorten the bilateral uterosacral ligaments. | Procedure or surgery | Sacrospinous Ligament Suspension Group |
Primary outcome
changes in POP-Q score at different time nodes
Time frame: pre-operation and post-operation(at 1month, 3 month, 6 month and a year)
Gynecological examination
8 secondary outcomes
UDI-6 scores at different time nodes UDI-6
Time frame: pre-operation and post-operation(at 1month, 3 month, 6 month and a year)
Postoperative urinary incontinence assessment
Time frame: post-operation(at 1month, 3 month, 6 month and a year)
OABss score at different time nodes
Time frame: post-operation(at 1month, 3 month, 6 month and a year)
PFDI-20 score at different time nodes
Time frame: post-operation(at 1month, 3 month, 6 month and a year)
ICIQ-SF score at different time nodes
Time frame: post-operation(at 1month, 3 month, 6 month and a year)
I-QoL score at different time nodes
Time frame: post-operation(at 1month, 3 month, 6 month and a year)
PISQ-12 score at different time nodes
Time frame: post-operation(at 1month, 3 month, 6 month and a year)
PFIQ-7 score at different time nodes
Time frame: post-operation(at 1month, 3 month, 6 month and a year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: Yes. Extraperitoneal high uterosacral ligament sling is effective in treating pelvic organ prolapse, and postoperative anatomical recovery is good, not inferior to traditional sacral ligament sling
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
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Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
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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
Pelvic Floor Dysfunction, Perineal Laceration
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.
xiuli sun, professor study chair
Beijing Key Laboratory of Female Pelvic Floor Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extraperitoneal high sacral ligament suspension surgery and Sacrospinous ligament fixation in people with 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 4 inclusion and 4 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 12 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiuli sun, professor (010-88324354, sunxiuli03351@126.com), or a site near the patient. 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(at 1month, 3 month, 6 month and a year)). 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 12 Jan 2022.