Urogenital ProlapseNCT03005613
Sacrospinous Ligament Fixation vs Ischial Spine Fascia Fixation
A study testing ischial spine fascia fixation and sacrospinous ligament fixation in people with Urogenital Prolapse, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Urogenital Prolapse
- What is being tested?
- ischial spine fascia fixation and sacrospinous ligament fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2017to 1 Feb 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age≤65 years, for those scheduled to receive hysterectomy age≥40 years
- patients with symptomatic stage II~IV uterine or vaginal vault prolapse
- receiving SSLF or ISFF in the gynecological department at Peking Union Medical College Hospital
Who cannot join
- plans to live abroad within follow-up span
- contradiction to these two operations: acute genital infection, narrow vagina (less than two finger-breadth), too-ill to receive operations
- patients with hip joint problem who could not pose a lithotomy position
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Ob & Gyn, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation
A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.
Read the detailed description
Investigational intervention：SSLF or ISFF operations
Study title：A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.
Principal Investigator：Chang Ren, M.D., Department of Obstetrics \& Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College.
Study subjects：Adult patients with symptomatic stage II~IV pelvic organ prolapse will be eligible if all the inclusion criteria are met and without any reason for exclusion.
Study objectives：The primary objective of this study is to assess the short and mid-term efficacy of Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation in treating stage II~ IV pelvic organ prolapse and their recurrence rate as well as their impacts on quality of life.
Study design：Prospective, Single-Blind, Randomized, Clinical Trial
Intervention：
- ISFF group：Patients receive ISFF according to randomization.
- SSLF group：Patients receive SSLF according to randomization
Sample size：76 patients (38 in ISFF group, 38 in SSLF group)
Primary endpoint:
•objective success rates at 3 months after operations.
Secondary endpoints:
- peri-operative parameters .
- subjective satisfactory rates at 1 year after operations
- quality of life questionnaires at 1 year after operations
Safety endpoints: complications
- Conditions
- Urogenital Prolapse
- Being tested
- ischial spine fascia fixation, sacrospinous ligament fixation
- Keywords
- Pelvic organ prolapse, Sacrospinous ligament fixation, Ischial spine fascia fixation, Clinical outcome
- 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.
ischial spine fascia fixationProcedure or surgery
The participants will receive ischial spine fascia fixation.
sacrospinous ligament fixationProcedure or surgery
The participants will receive sacrospinous ligament fixation.
| Study group | Role | What they receive |
|---|---|---|
| sacrospinous ligament fixation group | Active comparator | The patients will receive sacrospinous ligament fixation operation. Receives: Procedure: sacrospinous ligament fixation |
| ischial spine fascia fixation group | Experimental | The patients will receive ischial spine fascia fixation operation. Receives: Procedure: ischial spine fascia fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective success
no prolapse, stage I or only asymptomatic stage II prolapse
Measured: 3 months after operation
Secondary outcomes (6)
Pelvic Floor Distress Inventory-20 (PFDI-20)
to evaluate the quality of life in 3 domains
Measured: Change from Baseline in PFDI-20 at 3 months and 1 year
Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
to evaluate the quality of life in 3 domains
Measured: Change from Baseline in PFIQ-7 at 3 months and 1 year
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12)
to evaluate the sexual function
Measured: Change from Baseline in PISQ-12 at 3 months and 1 year
complications
peri-operative:massive bleeding, organ injury; post-operative: pelvic hematoma, pain, de novo UI, de novo dyspareunia
Measured: through study completion, an average of 1 year
recurrence rate
more than asymptomatic stage II prolapse after 3 months
Measured: 3 months after operation
subjective satisfaction ( according to a scale of 5 degrees: significantly worse, worse, no change, improved, greatly improved)
Patient's response as improved or greatly improved
Measured: 1 year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start15 Jan 2017
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Urogenital ProlapseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chang Ren, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005613
- Sponsor's protocol ID
- RC-H0407-8160061244
- Status last verified
- Feb 2023
- First submitted
- 15 Dec 2016
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Dwyer PL, Lee ET, Hay DM. Obesity and urinary incontinence in women. Br J Obstet Gynaecol. 1988 Jan;95(1):91-6. doi: 10.1111/j.1471-0528.1988.tb06486.x.
PubMed 3342213Sze EH, Karram MM. Transvaginal repair of vault prolapse: a review. Obstet Gynecol. 1997 Mar;89(3):466-75. doi: 10.1016/S0029-7844(96)00337-7.
PubMed 9052607Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.
PubMed 9083302Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.
PubMed 20966694Boyles SH, Weber AM, Meyn L. Procedures for pelvic organ prolapse in the United States, 1979-1997. Am J Obstet Gynecol. 2003 Jan;188(1):108-15. doi: 10.1067/mob.2003.101.
PubMed 12548203Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1.
PubMed 24142057Jones KA, Shepherd JP, Oliphant SS, Wang L, Bunker CH, Lowder JL. Trends in inpatient prolapse procedures in the United States, 1979-2006. Am J Obstet Gynecol. 2010 May;202(5):501.e1-7. doi: 10.1016/j.ajog.2010.01.017. Epub 2010 Mar 11.
PubMed 20223444Zhu L, Lang J, Zhang Q. Clinical study of ischia spinous fascia fixation--a new pelvic reconstructive surgery. Int Urogynecol J. 2011 Apr;22(4):499-503. doi: 10.1007/s00192-010-1307-x.
PubMed 21060988
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation
- ClinicalTrials.gov ID
- NCT03005613
- Acronym / sponsor ID
- RC-H0407-8160061244
- Conditions
- Urogenital Prolapse
- Keywords
- Pelvic organ prolapse, Sacrospinous ligament fixation, Ischial spine fascia fixation, Clinical outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 29 Dec 2016 (estimated)
- 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.
A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.
Detailed description
Investigational intervention：SSLF or ISFF operations
Study title：A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.
Principal Investigator：Chang Ren, M.D., Department of Obstetrics \& Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College.
Study subjects：Adult patients with symptomatic stage II~IV pelvic organ prolapse will be eligible if all the inclusion criteria are met and without any reason for exclusion.
Study objectives：The primary objective of this study is to assess the short and mid-term efficacy of Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation in treating stage II~ IV pelvic organ prolapse and their recurrence rate as well as their impacts on quality of life.
Study design：Prospective, Single-Blind, Randomized, Clinical Trial
Intervention：
- ISFF group：Patients receive ISFF according to randomization.
- SSLF group：Patients receive SSLF according to randomization
Sample size：76 patients (38 in ISFF group, 38 in SSLF group)
Primary endpoint:
•objective success rates at 3 months after operations.
Secondary endpoints:
- peri-operative parameters .
- subjective satisfactory rates at 1 year after operations
- quality of life questionnaires at 1 year after operations
Safety endpoints: complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sacrospinous ligament fixation group | Active comparator | Procedure: sacrospinous ligament fixationThe patients will receive sacrospinous ligament fixation operation. |
| ischial spine fascia fixation group | Experimental | Procedure: ischial spine fascia fixationThe patients will receive ischial spine fascia fixation operation. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age≤65 years, for those scheduled to receive hysterectomy age≥40 years
- patients with symptomatic stage II~IV uterine or vaginal vault prolapse
- receiving SSLF or ISFF in the gynecological department at Peking Union Medical College Hospital
Key exclusion criteria (3 listed)
- plans to live abroad within follow-up span
- contradiction to these two operations: acute genital infection, narrow vagina (less than two finger-breadth), too-ill to receive operations
- patients with hip joint problem who could not pose a lithotomy position
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 |
|---|---|---|
| ischial spine fascia fixationThe participants will receive ischial spine fascia fixation. | Procedure or surgery | ischial spine fascia fixation group |
| sacrospinous ligament fixationThe participants will receive sacrospinous ligament fixation. | Procedure or surgery | sacrospinous ligament fixation group |
Primary outcome
objective success
Time frame: 3 months after operation
no prolapse, stage I or only asymptomatic stage II prolapse
6 secondary outcomes
Pelvic Floor Distress Inventory-20 (PFDI-20)
Time frame: Change from Baseline in PFDI-20 at 3 months and 1 year
Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
Time frame: Change from Baseline in PFIQ-7 at 3 months and 1 year
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12)
Time frame: Change from Baseline in PISQ-12 at 3 months and 1 year
complications
Time frame: through study completion, an average of 1 year
recurrence rate
Time frame: 3 months after operation
subjective satisfaction ( according to a scale of 5 degrees: significantly worse, worse, no change, improved, greatly improved)
Time frame: 1 year after operation
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 16 Jan 2026.
- Background: PubMed 3342213Dwyer PL, Lee ET, Hay DM. Obesity and urinary incontinence in women. Br J Obstet Gynaecol. 1988 Jan;95(1):91-6. doi: 10.1111/j.1471-0528.1988.tb06486.x.
- Background: PubMed 9052607Sze EH, Karram MM. Transvaginal repair of vault prolapse: a review. Obstet Gynecol. 1997 Mar;89(3):466-75. doi: 10.1016/S0029-7844(96)00337-7.
- Background: PubMed 9083302Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.
- Background: PubMed 20966694Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.
- Background: PubMed 12548203Boyles SH, Weber AM, Meyn L. Procedures for pelvic organ prolapse in the United States, 1979-1997. Am J Obstet Gynecol. 2003 Jan;188(1):108-15. doi: 10.1067/mob.2003.101.
- Background: PubMed 24142057Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1.
- Background: PubMed 20223444Jones KA, Shepherd JP, Oliphant SS, Wang L, Bunker CH, Lowder JL. Trends in inpatient prolapse procedures in the United States, 1979-2006. Am J Obstet Gynecol. 2010 May;202(5):501.e1-7. doi: 10.1016/j.ajog.2010.01.017. Epub 2010 Mar 11.
- Background: PubMed 21060988Zhu L, Lang J, Zhang Q. Clinical study of ischia spinous fascia fixation--a new pelvic reconstructive surgery. Int Urogynecol J. 2011 Apr;22(4):499-503. doi: 10.1007/s00192-010-1307-x.
- 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. This study is not recruiting at the moment.
Chang Ren, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ischial spine fascia fixation and sacrospinous ligament fixation in people with Urogenital Prolapse, run by Peking Union Medical College 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 3 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: finished, as of the sponsor's last update on 16 Jan 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?
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?
objective success (time frame: 3 months after operation). 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 NCT03005613, which also lists 8 linked publications.
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 16 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.