Pelvic Organ ProlapseNCT06418438
A Randomized Controlled Trail of Uterosacral Ligament Suspension in the Treatment of Pelvic Organ Prolapse
A study testing Laparoscopic uterosacral ligament suspension with hysterectomy and Laparoscopic uterosacral ligament suspension with cervical amputation in people with Pelvic Organ Prolapse, run by Lan Zhu.
Trial summary
Pelvic organ prolapse (POP) is one of the common benign gynecological disorders in middle-aged and elderly women, which severely affects patients' quality of life and increases the social burden. The lifetime risk of undergoing surgery for POP is 12.6%. 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?
- Laparoscopic uterosacral ligament suspension with hysterectomy and Laparoscopic uterosacral ligament suspension with cervical amputation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 ≥ 18 years with symptomatic stage II or higher uterine prolapse (C ≥ +1cm) and gynecological ultrasonography confirming cervical length ≥ 4cm. Concurrent anterior and/or posterior vaginal wall prolapse may be present.
- Preoperative pelvic ultrasound and cervical screening show no abnormalities.
- The patient does not have a desire for future fertility.
- Willingness and ability to adhere to the follow-up treatment plan.
- Competence to provide informed consent.
Who cannot join
- Suspected untreated lower genital tract tumor, accompanied by other uterine, ovarian, and cervical lesions requiring surgical intervention, indicating contraindication for uterine preservation.
- Patients with a history of total hysterectomy/subtotal hysterectomy.
- Patients who have previously undergone pelvic organ prolapse surgery or other pelvic floor surgeries.
- Patients with contraindications for laparoscopic surgery, such as intestinal obstruction.
- Patients with intestinal hernia.
- Patients with gynecological and urinary tract infections, anticoagulant therapy, coagulation disorders, previous pelvic radiotherapy, as well as neurological or medical conditions affecting bladder and bowel function (such as multiple sclerosis, spinal cord injury, or residual neurological dysfunction caused by stroke), and patients with underlying conditions such as chronic pelvic pain, who are at higher risk for surgery.
- Simultaneous anti-urinary incontinence surgery is required for this procedure.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: To Compare the Clinical Efficacy and Safety of Laparoscopic Uterosacral Ligament Suspension With or Without Hysterectomy in the Treatment of POP
Pelvic organ prolapse (POP) is one of the common benign gynecological disorders in middle-aged and elderly women, which severely affects patients' quality of life and increases the social burden. The lifetime risk of undergoing surgery for POP is 12.6%. Surgery is an important treatment modality for POP, and currently, there are various surgical procedures used in clinical practice, but there is still no clear consensus on which procedure is superior. Autologous tissue repair remains crucial in pelvic floor reconstruction surgery, and high uterosacral ligament suspension (HUSLS) via a vaginal approach is a classic corrective procedure for central pelvic defects. However, with the development of minimally invasive techniques, laparoscopic uterosacral ligament suspension (LUSLS) has been widely used in the field of pelvic floor reconstruction. Compared to the vaginal approach, LUSLS is easier to perform, has a shorter learning curve, provides better exposure of the ureters, and allows for higher-quality suture placement under safe conditions. The main controversial clinical issue in the industry regarding high uterosacral ligament suspension is whether to perform uterine preservation, with the core concern being the risk of postoperative recurrence. High uterosacral ligament suspension with uterine preservation achieves level I repair by fixing the lower segment or cervix to supporting structures. Its advantages include shorter operation time, less blood loss, and the preservation of the patient's fertility. Many women request uterine preservation for various reasons. Therefore, high-quality research is needed to guide the clinical decision-making regarding uterine preservation in high uterosacral ligament suspension. Previous studies have found that approximately 40% of patients with pelvic organ prolapse have concurrent cervical elongation. For patients with cervical elongation, symptoms in the central pelvic region are mainly caused by the protrusion of elongated cervical tissue into the vagina. Removing the elongated cervix significantly reduces the need for biological support in pelvic floor reconstruction, making autologous tissue repair strategies the preferred option for this patient population while providing a foundation for uterine preservation. Based on long-term observational studies, the Department of Obstetrics and Gynecology at Peking Union Medical College Hospital has proposed combining laparoscopic uterosacral ligament suspension with cervical amputation for the treatment of pelvic organ prolapse with cervical elongation. This study aims to compare whether uterine preservation in laparoscopic uterosacral ligament suspension is non-inferior to uterine removal, providing more treatment options for future patients with pelvic organ prolapse and cervical elongation.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Laparoscopic uterosacral ligament suspension with hysterectomy, Laparoscopic uterosacral ligament suspension with cervical amputation
- 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.
Laparoscopic uterosacral ligament suspension with hysterectomyProcedure or surgery
After anesthesia, bladder stone removal patients undergo laparoscopic hysterectomy. The adnexa are coagulated and cut, and the bladder peritoneal reflection is opened. The uterus is removed transvaginally. Next, laparoscopic uterosacral ligament suspension is performed. The right and left uterosacral ligaments are freed and sutured to lift the residual end.
Laparoscopic uterosacral ligament suspension with cervical amputationProcedure or surgery
After anesthesia, bladder stone removal patients undergo cervical amputation surgery. The cervix is exposed and elevated using Allis forceps. A dilator is used to expand the cervix, and an incision is made on the anterior vaginal wall. The cervix is excised and shaped using the Sturmdorf method. Afterward, laparoscopic uterosacral ligament suspension is performed. The right and left uterosacral ligaments are freed and sutured to lift the uterus.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic uterosacral ligament suspension with hysterectomy | Active comparator | Not described Receives: Procedure: Laparoscopic uterosacral ligament suspension with hysterectomy |
| Laparoscopic uterosacral ligament suspension with cervical amputation | Experimental | Not described Receives: Procedure: Laparoscopic uterosacral ligament suspension with cervical amputation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite success rate at the one-year follow-up
- No sensation of vaginal bulge or protrusion, indicated by a response of "no" or a score of 0 on question 3 of the PFDI-20 questionnaire, which asks, "Do you often see or feel a bulge or something falling out of your vagina?"
- No further treatment (surgical or non-surgical) required for POP (Pelvic Organ Prolapse).
- Absence of POP-Q points at the hymen or beyond the hymen, indicating that Aa, Ba, C, Ap, and Bp are all < 0cm.
Measured: At the one-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study startJun 2024 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lan Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lan Zhu, Peking Union Medical College Hospital
- Investigators
- Lan Zhu, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418438
- Sponsor's protocol ID
- K5787
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Clinical Efficacy and Safety of Laparoscopic Uterosacral Ligament Suspension With or Without Hysterectomy in the Treatment of POP
- ClinicalTrials.gov ID
- NCT06418438
- Acronym / sponsor ID
- K5787
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Lan ZhuUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 17 May 2024 (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.
Pelvic organ prolapse (POP) is one of the common benign gynecological disorders in middle-aged and elderly women, which severely affects patients' quality of life and increases the social burden. The lifetime risk of undergoing surgery for POP is 12.6%. Surgery is an important treatment modality for POP, and currently, there are various surgical procedures used in clinical practice, but there is still no clear consensus on which procedure is superior. Autologous tissue repair remains crucial in pelvic floor reconstruction surgery, and high uterosacral ligament suspension (HUSLS) via a vaginal approach is a classic corrective procedure for central pelvic defects. However, with the development of minimally invasive techniques, laparoscopic uterosacral ligament suspension (LUSLS) has been widely used in the field of pelvic floor reconstruction. Compared to the vaginal approach, LUSLS is easier to perform, has a shorter learning curve, provides better exposure of the ureters, and allows for higher-quality suture placement under safe conditions. The main controversial clinical issue in the industry regarding high uterosacral ligament suspension is whether to perform uterine preservation, with the core concern being the risk of postoperative recurrence. High uterosacral ligament suspension with uterine preservation achieves level I repair by fixing the lower segment or cervix to supporting structures. Its advantages include shorter operation time, less blood loss, and the preservation of the patient's fertility. Many women request uterine preservation for various reasons. Therefore, high-quality research is needed to guide the clinical decision-making regarding uterine preservation in high uterosacral ligament suspension. Previous studies have found that approximately 40% of patients with pelvic organ prolapse have concurrent cervical elongation. For patients with cervical elongation, symptoms in the central pelvic region are mainly caused by the protrusion of elongated cervical tissue into the vagina. Removing the elongated cervix significantly reduces the need for biological support in pelvic floor reconstruction, making autologous tissue repair strategies the preferred option for this patient population while providing a foundation for uterine preservation. Based on long-term observational studies, the Department of Obstetrics and Gynecology at Peking Union Medical College Hospital has proposed combining laparoscopic uterosacral ligament suspension with cervical amputation for the treatment of pelvic organ prolapse with cervical elongation. This study aims to compare whether uterine preservation in laparoscopic uterosacral ligament suspension is non-inferior to uterine removal, providing more treatment options for future patients with pelvic organ prolapse and cervical elongation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic uterosacral ligament suspension with hysterectomy | Active comparator | Procedure: Laparoscopic uterosacral ligament suspension with hysterectomy |
| Laparoscopic uterosacral ligament suspension with cervical amputation | Experimental | Procedure: Laparoscopic uterosacral ligament suspension with cervical amputation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years with symptomatic stage II or higher uterine prolapse (C ≥ +1cm) and gynecological ultrasonography confirming cervical length ≥ 4cm. Concurrent anterior and/or posterior vaginal wall prolapse may be present.
- Preoperative pelvic ultrasound and cervical screening show no abnormalities.
- The patient does not have a desire for future fertility.
- Willingness and ability to adhere to the follow-up treatment plan.
- Competence to provide informed consent.
Key exclusion criteria (7 listed)
- Suspected untreated lower genital tract tumor, accompanied by other uterine, ovarian, and cervical lesions requiring surgical intervention, indicating contraindication for uterine preservation.
- Patients with a history of total hysterectomy/subtotal hysterectomy.
- Patients who have previously undergone pelvic organ prolapse surgery or other pelvic floor surgeries.
- Patients with contraindications for laparoscopic surgery, such as intestinal obstruction.
- Patients with intestinal hernia.
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 |
|---|---|---|
| Laparoscopic uterosacral ligament suspension with hysterectomyAfter anesthesia, bladder stone removal patients undergo laparoscopic hysterectomy. The adnexa are coagulated and cut, and the bladder peritoneal reflection is opened. The uterus is removed transvaginally. Next, laparoscopic uterosacral ligament suspension is performed. The right and left uterosacral ligaments are freed and sutured to lift the residual end. | Procedure or surgery | Laparoscopic uterosacral ligament suspension with hysterectomy |
| Laparoscopic uterosacral ligament suspension with cervical amputationAfter anesthesia, bladder stone removal patients undergo cervical amputation surgery. The cervix is exposed and elevated using Allis forceps. A dilator is used to expand the cervix, and an incision is made on the anterior vaginal wall. The cervix is excised and shaped using the Sturmdorf method. Afterward, laparoscopic uterosacral ligament suspension is performed. The right and left uterosacral ligaments are freed and sutured to lift the uterus. | Procedure or surgery | Laparoscopic uterosacral ligament suspension with cervical amputation |
Primary outcome
The composite success rate at the one-year follow-up
Time frame: At the one-year follow-up
1. No sensation of vaginal bulge or protrusion, indicated by a response of "no" or a score of 0 on question 3 of the PFDI-20 questionnaire, which asks, "Do you often see or feel a bulge or something falling out of your vagina?" 2. No further treatment (surgical or non-surgical) required for POP (Pelvic Organ Prolapse). 3. Absence of POP-Q points at the hymen or beyond the hymen, indicating that Aa, Ba, C, Ap, and Bp are all < 0cm.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
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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.
Lan Zhu, MD principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic uterosacral ligament suspension with hysterectomy and Laparoscopic uterosacral ligament suspension with cervical amputation in people with Pelvic Organ Prolapse, run by Lan Zhu.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Zhou, MD (+8613681253992, shellypumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite success rate at the one-year follow-up (time frame: At the one-year follow-up). 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 17 May 2024.