Pelvic Organ Prolapse (POP)NCT06903988

Efficacy and Safety of Laparoscopic Lateral Suspension and Transvaginal Sacrospinous Ligament Fixation in Patients With Pelvic Organ Prolapse

A study testing laparoscopic lateral suspension and Transvaginal sacrospinous ligament fixation in people with Pelvic Organ Prolapse (POP), run by Peking University People's Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pelvic Organ Prolapse (POP)
What is being tested?: laparoscopic lateral suspension and Transvaginal sacrospinous ligament fixation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 86 participants
Where: 1 siteChina
Study dates: 5 Apr 2025to 31 Aug 2026
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;
According to the POP-Q classification, patients who meet any of the following conditions: a. Patients with anterior wall prolapse of stage III or higher; b. Patients with apical prolapse of stage III or higher;
Patients who refuse conservative treatment or have ineffective conservative treatment and request surgical treatment for prolapse;
Patients who voluntarily participate in this study, sign the informed consent form, and are able to attend follow-up visits on time;
Patients who have received education at the primary school level or above;
Patients who are able to visit the hospital for examinations;
Patients who are deemed fit to undergo surgery according to preoperative anesthesia assessment.

Who cannot join

Patients who have previously undergone surgery for pelvic organ prolapse (POP);
Patients with a history of anti-incontinence surgery or who are planned to undergo mid-urethral sling surgery for anti-incontinence during the current operation;
Patients who, after evaluation by the surgeon, have other conditions that affect eligibility for inclusion.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University People's Hospital
Beijing, 100044

Other trials in China

About this study

Official title: A Randomized Controlled Study on the Efficacy and Safety of Laparoscopic Lateral Suspension and Transvaginal Sacrospinous Ligament Fixation in Patients With Pelvic Organ Prolapse

This study is a single-center, non-blinded, non-inferiority randomized controlled trial, planning to recruit 86 patients with Stage III or higher pelvic organ prolapse who are unresponsive to conservative treatment and are requesting surgical treatment. Patients who meet the inclusion and exclusion criteria will be randomly assigned to the transvaginal sacrospinous ligament fixation group and the laparoscopic lateral suspension group in a 1:1 ratio. Follow-ups will be conducted at 1 month, 3 months, 6 months, and 1 year after surgery for the enrolled patients. The primary outcome measure is the difference in surgical success rate between the two groups of patients at 1 year after surgery. We hypothesize that the surgical success rate of laparoscopic lateral suspension is not inferior to that of transvaginal sacrospinous ligament fixation

Conditions: Pelvic Organ Prolapse (POP)
Being tested: laparoscopic lateral suspension, Transvaginal sacrospinous ligament fixation
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 lateral suspensionProcedure or surgery
Laparoscopic lateral suspension: Place a 1/2 T4 mesh in the vesicovaginal space. The two lateral slings are passed out from the outer upper side of the bilateral anterior superior iliac spine, and the prolapsed organs are suspended to the abdominal wall.
Transvaginal sacrospinous ligament fixationProcedure or surgery
Transvaginal sacrospinous ligament fixation: Dissect the rectovaginal space to expose the right sacrospinous ligament, and fix the cervix or vaginal cuff to the right sacrospinous ligament.

Study groups in NCT06903988
Study group	Role	What they receive
laparoscopic lateral suspension	Experimental	Not described Receives: Procedure: laparoscopic lateral suspension
transvaginal sacrospinous ligament fixation	Active comparator	Not described Receives: Procedure: Transvaginal sacrospinous ligament fixation

What is being measured

The primary outcome is the main question the study is designed to answer.

Surgical success rate
Surgical success is defined as follows:
1. Points Aa, Ba, Ap, and Bp do not exceed the hymenal margin;
2. The descent of point C does not exceed one-third of the total vaginal length;
3. During the follow-up period, the patient does not require pessary treatment or undergo further surgery for pelvic organ prolapse;
4. Questions 3 of the Pelvic Floor Dysfunction Inventory (PFDI)-20 questionnaire are answered as "none" or "no impact."
Measured: From enrollment to the end of surgery at 1 year

Secondary outcomes (7)

Incidence of urinary retention after catheter removal
A residual urine volume greater than 100 ml as measured by ultrasound is considered urinary retention.
Measured: From enrollment to the end of surgery at 3 days
Differences in the severity of overactive bladder (OAB) after surgery
It will be assessed by using the Overactive Bladder Symptom Score (OABSS). The score of OABSS ranges from 0 to 15. The higher the score, the more severe the overactive bladder condition is.
Measured: 1 month, 3 months, 6 months and 1 year post-surgery
Differences in the severity of urinary incontinence after surgery
It will be assessed by using the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF). The score of ICIQ-SF ranges from 0 to 21. The higher the score, the more severe the urinary incontinence condition is.
Measured: 1 month, 3 months, 6 months and 1 year post-surgery
Differences in the severity of pelvic floor dysfunction after surgery
It will be assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20).The score of PFDI-20 ranges from 0 to 300. The higher the score, the more severe the pelvic floor dysfunction is.
Measured: 1 month, 3 months, 6 months and 1 year post-surgery
Differences in quality of life after surgery
It will be assessed using the Pelvic Floor Impact Questionnaire (PFIQ).The score of PFIQ ranges from 0 to 300. The higher the score, the poorer the patient's quality of life is.
Measured: 1 month, 3 months, 6 months and 1 year post-surgery
Differences in patients' satisfaction
It will be assessed using the Patient Global Impression of Improvement (PGI-I) questionnaire. The score of PGI-I ranges from 0 to 7. The higher the score, the lower the patient's satisfaction is.
Measured: 1 month, 3 months, 6 months and 1 year post-surgery
Postoperative Pain
It will be assessed using the Wong-Baker Faces Pain Rating Scale (FPS-R). The score of FPS-R ranges from 0 to 10. The higher the score, the more severe the pain is.
Measured: 1 month, 3 months, 6 months and 1 year post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Apr 202531 Aug 2026

First posted1 Apr 2025
Study start5 Apr 2025
Primary completion30 Aug 2026 (estimated)
Study completion31 Aug 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pelvic Organ Prolapse (POP)Studies 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: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 86 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06903988
Sponsor's protocol ID: 2024PHB374-002
Status last verified: Jan 2026
First submitted: 24 Mar 2025
Last updated: 2 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
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
Not yet recruitingPhase 4
Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management
Pelvic Organ Prolapse (POP), Postoperative Pain
Active, not recruiting
A Novel Laparoscopic Apical Promontofixation Technique With Simultaneous Perineal Reconstruction for Patients With Symptomatic Pelvic Organ Prolapse
Pelvic Organ Prolapse (POP), Urinary Incontinence , Stress
Not yet recruitingPhase 4
Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery
Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI)

All Pelvic Organ Prolapse (POP) trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Study on the Efficacy and Safety of Laparoscopic Lateral Suspension and Transvaginal Sacrospinous Ligament Fixation in Patients With Pelvic Organ Prolapse
ClinicalTrials.gov ID: NCT06903988
Acronym / sponsor ID: 2024PHB374-002
Conditions: Pelvic Organ Prolapse (POP)
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 86 participants (estimated)
Lead sponsor: Peking University People's HospitalUniversity, hospital or other
Study start: 5 Apr 2025 (actual)
Primary completion: 30 Aug 2026 (estimated)
Study completion: 31 Aug 2026 (estimated)
First posted: 1 Apr 2025 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
laparoscopic lateral suspension	Experimental	Procedure: laparoscopic lateral suspension
transvaginal sacrospinous ligament fixation	Active comparator	Procedure: Transvaginal sacrospinous ligament fixation

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age ≥ 18 years;
According to the POP-Q classification, patients who meet any of the following conditions: a. Patients with anterior wall prolapse of stage III or higher; b. Patients with apical prolapse of stage III or higher;
Patients who refuse conservative treatment or have ineffective conservative treatment and request surgical treatment for prolapse;
Patients who voluntarily participate in this study, sign the informed consent form, and are able to attend follow-up visits on time;
Patients who have received education at the primary school level or above;

Key exclusion criteria (3 listed)

Patients who have previously undergone surgery for pelvic organ prolapse (POP);
Patients with a history of anti-incontinence surgery or who are planned to undergo mid-urethral sling surgery for anti-incontinence during the current operation;
Patients who, after evaluation by the surgeon, have other conditions that affect eligibility for inclusion.

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 lateral suspensionLaparoscopic lateral suspension: Place a 1/2 T4 mesh in the vesicovaginal space. The two lateral slings are passed out from the outer upper side of the bilateral anterior superior iliac spine, and the prolapsed organs are suspended to the abdominal wall.	Procedure or surgery	laparoscopic lateral suspension
Transvaginal sacrospinous ligament fixationTransvaginal sacrospinous ligament fixation: Dissect the rectovaginal space to expose the right sacrospinous ligament, and fix the cervix or vaginal cuff to the right sacrospinous ligament.	Procedure or surgery	transvaginal sacrospinous ligament fixation

Primary outcome

Surgical success rate
Time frame: From enrollment to the end of surgery at 1 year
Surgical success is defined as follows: 1. Points Aa, Ba, Ap, and Bp do not exceed the hymenal margin; 2. The descent of point C does not exceed one-third of the total vaginal length; 3. During the follow-up period, the patient does not require pessary treatment or undergo further surgery for pelvic organ prolapse; 4. Questions 3 of the Pelvic Floor Dysfunction Inventory (PFDI)-20 questionnaire are answered as "none" or "no impact."

7 secondary outcomes

Incidence of urinary retention after catheter removal
Time frame: From enrollment to the end of surgery at 3 days
Differences in the severity of overactive bladder (OAB) after surgery
Time frame: 1 month, 3 months, 6 months and 1 year post-surgery
Differences in the severity of urinary incontinence after surgery
Time frame: 1 month, 3 months, 6 months and 1 year post-surgery
Differences in the severity of pelvic floor dysfunction after surgery
Time frame: 1 month, 3 months, 6 months and 1 year post-surgery
Differences in quality of life after surgery
Time frame: 1 month, 3 months, 6 months and 1 year post-surgery
Differences in patients' satisfaction
Time frame: 1 month, 3 months, 6 months and 1 year post-surgery
Postoperative Pain
Time frame: 1 month, 3 months, 6 months and 1 year post-surgery

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 2 Feb 2026.
Individual participant dataSharing planned: Yes

Related trials for Pelvic Organ Prolapse (POP)

Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
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
Not yet recruitingPhase 4
Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management
Pelvic Organ Prolapse (POP), Postoperative Pain
Active, not recruiting
A Novel Laparoscopic Apical Promontofixation Technique With Simultaneous Perineal Reconstruction for Patients With Symptomatic Pelvic Organ Prolapse
Pelvic Organ Prolapse (POP), Urinary Incontinence , Stress
Not yet recruitingPhase 4
Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery
Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI)

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?

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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 2 Feb 2026. 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?

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?

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?

Surgical success rate (time frame: From enrollment to the end of surgery at 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06903988.

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 2 Feb 2026.