Pelvic Organ ProlapseNCT06418451
A Randomized Controlled Trial of Modified Ischial Spinous Fascia Fixation and Sacrospinous Ligament Fixation in the Treatment of Pelvic Organ Prolapse
A study testing sacrospinous ligament fixation (SLFF) and modified ischial spinous fascia fixation (modified ISFF) in people with Pelvic Organ Prolapse, run by Lan Zhu.
Trial summary
Background: Pelvic organ prolapse is one of the most common benign gynecological disorders in middle-aged and elderly women, and it has a significant negative impact on women's social, physical, and psychological health. 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?
- sacrospinous ligament fixation (SLFF) and modified ischial spinous fascia fixation (modified ISFF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 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
- Patients with symptomatic mid-pelvic organ prolapse (POP-Q stage ≥ II) who may concurrently have anterior and/or posterior pelvic organ prolapse.
- Patients willing to undergo long-term follow-up for at least one year.
- Patients willing to sign an informed consent form and participate in this study.
Who cannot join
- Patients who have undergone previous POP or urinary incontinence surgery with the use of implant materials.
- Patients who require simultaneous anti-urinary incontinence surgery for the current procedure.
- Contraindications for general anesthesia and surgical intervention, such as severe medical comorbidities that render the patient unable to tolerate surgery.
- Patients who wish to preserve the uterus.
- Patients in the active phase of genital, urinary, or systemic infections.
- Patients who, for other reasons (such as having genital malignancies), choose not to undergo SSLF/modified ISFF surgical intervention at the moment.
- Patients who are unable or unwilling to attend follow-up visits (excluding those who may be willing to participate in telephone follow-up).
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 Complications of Modified Ischial Spinous Fascia Fixation and Sacrospinous Ligament Fixation in the Treatment of Pelvic Organ Prolapse
Background: Pelvic organ prolapse is one of the most common benign gynecological disorders in middle-aged and elderly women, and it has a significant negative impact on women's social, physical, and psychological health. Sacrospinous ligament fixation (SSLF) is one of the main surgical procedures for reconstructing pelvic floor defects. In previous studies, the ischial spine fascia fixation (ISFF) technique developed by our team has been shown to be a safe and effective alternative to SSLF. However, both procedures have inadequate support for the anterior vaginal wall. Therefore, based on the traditional ISFF, we fix the anterior vaginal wall to the ipsilateral ischial spine fascia to enhance support for the anterior vaginal wall. This modified procedure is called modified ISFF. This trial aims to compare the subjective and objective therapeutic effects, recurrence rates, quality of life, perioperative parameters, and complications of modified ISFF and SSLF in the treatment of patients with pelvic organ prolapse of degrees II-IV.
Methods: This trial is a randomized controlled multicenter non-inferiority trial. The primary outcome measure is the composite surgical success rate at one-year follow-up, defined as the absence of subjective vaginal bulge symptoms, no need for retreatment, and absence of POP-Q points at or beyond the hymen or vaginal introitus, i.e., Aa, Ba, C, Ap, Bp all < 0 cm. The secondary outcomes include anatomical outcomes of each vaginal segment based on the POP-Q score, subjective improvement in quality of life evaluated by questionnaires (PFIQ-7, PFDI-20, PISQ-12, and PGI-I), perioperative parameters (operation time, blood loss, length of hospital stay, pain VAS score, hospital costs), and complications. Data analysis will be conducted according to the intention-to-treat principle. Based on a composite success rate of 88% and a non-inferiority margin of -10% (one-sided α = 0.025, β = 0.2), 370 patients will be recruited from 9 centers, including a 10% dropout rate. The purpose of this study is to investigate whether modified ISFF is non-inferior to SSLF in terms of clinical efficacy and complications.
Discussion: This multicenter non-inferiority trial will evaluate the effectiveness and safety of modified ISFF compared to SSLF in symptomatic patients with degrees II-IV uterovaginal prolapse. If modified ISFF is proven to be non-inferior to SSLF, it would be a preferable alternative for patients with a shorter vaginal length and those who have difficulties with SSLF due to anatomical factors.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- sacrospinous ligament fixation (SLFF), modified ischial spinous fascia fixation (modified ISFF)
- 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.
sacrospinous ligament fixation (SLFF)Procedure or surgery
SSLF is a surgical procedure used to treat vaginal apex prolapse by fixing the vaginal apex to the right sacrospinous ligament. The procedure involves marking and incising the posterior vaginal wall, dissecting the vaginal rectal space, and placing sutures on the outer one-third of the ligament. These sutures connect the vaginal apex to the attachment point of the right uterosacral ligament. Anterior/posterior vaginal wall repair procedures can be performed if needed, without using implant materials. SSLF provides enhanced support for the vaginal apex.
modified ischial spinous fascia fixation (modified ISFF)Procedure or surgery
The modified ISFF procedure involves making a midline incision along the posterior fornix of the vagina, exposing the ischial spine fascia. Two sutures are placed around the ischial spine and passed through the mucosa of the anterior and posterior vaginal walls, lifting the vaginal apex and anterior wall towards the spine. The procedure also allows for additional anterior/posterior vaginal wall repair if necessary, without using implant materials.
| Study group | Role | What they receive |
|---|---|---|
| sacrospinous ligament fixation (SLFF) | Active comparator | Not described Receives: Procedure: sacrospinous ligament fixation (SLFF) |
| modified ischial spinous fascia fixation (modified ISFF) | Experimental | Not described Receives: Procedure: modified ischial spinous fascia fixation (modified ISFF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite success rate
- 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
- 370 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
- NCT06418451
- Sponsor's protocol ID
- K5788
- 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 Complications of Modified Ischial Spinous Fascia Fixation and Sacrospinous Ligament Fixation in the Treatment of Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT06418451
- Acronym / sponsor ID
- K5788
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 370 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.
Background: Pelvic organ prolapse is one of the most common benign gynecological disorders in middle-aged and elderly women, and it has a significant negative impact on women's social, physical, and psychological health. Sacrospinous ligament fixation (SSLF) is one of the main surgical procedures for reconstructing pelvic floor defects. In previous studies, the ischial spine fascia fixation (ISFF) technique developed by our team has been shown to be a safe and effective alternative to SSLF. However, both procedures have inadequate support for the anterior vaginal wall. Therefore, based on the traditional ISFF, we fix the anterior vaginal wall to the ipsilateral ischial spine fascia to enhance support for the anterior vaginal wall. This modified procedure is called modified ISFF. This trial aims to compare the subjective and objective therapeutic effects, recurrence rates, quality of life, perioperative parameters, and complications of modified ISFF and SSLF in the treatment of patients with pelvic organ prolapse of degrees II-IV.
Methods: This trial is a randomized controlled multicenter non-inferiority trial. The primary outcome measure is the composite surgical success rate at one-year follow-up, defined as the absence of subjective vaginal bulge symptoms, no need for retreatment, and absence of POP-Q points at or beyond the hymen or vaginal introitus, i.e., Aa, Ba, C, Ap, Bp all < 0 cm. The secondary outcomes include anatomical outcomes of each vaginal segment based on the POP-Q score, subjective improvement in quality of life evaluated by questionnaires (PFIQ-7, PFDI-20, PISQ-12, and PGI-I), perioperative parameters (operation time, blood loss, length of hospital stay, pain VAS score, hospital costs), and complications. Data analysis will be conducted according to the intention-to-treat principle. Based on a composite success rate of 88% and a non-inferiority margin of -10% (one-sided α = 0.025, β = 0.2), 370 patients will be recruited from 9 centers, including a 10% dropout rate. The purpose of this study is to investigate whether modified ISFF is non-inferior to SSLF in terms of clinical efficacy and complications.
Discussion: This multicenter non-inferiority trial will evaluate the effectiveness and safety of modified ISFF compared to SSLF in symptomatic patients with degrees II-IV uterovaginal prolapse. If modified ISFF is proven to be non-inferior to SSLF, it would be a preferable alternative for patients with a shorter vaginal length and those who have difficulties with SSLF due to anatomical factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sacrospinous ligament fixation (SLFF) | Active comparator | Procedure: sacrospinous ligament fixation (SLFF) |
| modified ischial spinous fascia fixation (modified ISFF) | Experimental | Procedure: modified ischial spinous fascia fixation (modified ISFF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with symptomatic mid-pelvic organ prolapse (POP-Q stage ≥ II) who may concurrently have anterior and/or posterior pelvic organ prolapse.
- Patients willing to undergo long-term follow-up for at least one year.
- Patients willing to sign an informed consent form and participate in this study.
Key exclusion criteria (7 listed)
- Patients who have undergone previous POP or urinary incontinence surgery with the use of implant materials.
- Patients who require simultaneous anti-urinary incontinence surgery for the current procedure.
- Contraindications for general anesthesia and surgical intervention, such as severe medical comorbidities that render the patient unable to tolerate surgery.
- Patients who wish to preserve the uterus.
- Patients in the active phase of genital, urinary, or systemic infections.
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 |
|---|---|---|
| sacrospinous ligament fixation (SLFF)SSLF is a surgical procedure used to treat vaginal apex prolapse by fixing the vaginal apex to the right sacrospinous ligament. The procedure involves marking and incising the posterior vaginal wall, dissecting the vaginal rectal space, and placing sutures on the outer one-third of the ligament. These sutures connect the vaginal apex to the attachment point of the right uterosacral ligament. Anterior/posterior vaginal wall repair procedures can be performed if needed, without using implant materials. SSLF provides enhanced support for the vaginal apex. | Procedure or surgery | sacrospinous ligament fixation (SLFF) |
| modified ischial spinous fascia fixation (modified ISFF)The modified ISFF procedure involves making a midline incision along the posterior fornix of the vagina, exposing the ischial spine fascia. Two sutures are placed around the ischial spine and passed through the mucosa of the anterior and posterior vaginal walls, lifting the vaginal apex and anterior wall towards the spine. The procedure also allows for additional anterior/posterior vaginal wall repair if necessary, without using implant materials. | Procedure or surgery | modified ischial spinous fascia fixation (modified ISFF) |
Primary outcome
The composite success rate
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
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
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i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
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Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
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Pelvic Floor Muscle Training During Pregnancy
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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.
Lan Zhu, MD principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing sacrospinous ligament fixation (SLFF) and modified ischial spinous fascia fixation (modified ISFF) 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 3 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 (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.