Pelvic Organ ProlapseNCT01760603
Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse
A study testing ISFF in people with Pelvic Organ Prolapse, run by Peking Union Medical College Hospital at 4 sites in China.
Trial summary
Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous fascia fixation procedure is developed in China for vaginal apex fixation with native tissue. 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?
- ISFF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 4 sitesChina
- Study dates
- Dec 2012to Dec 2017
- 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
- Candidates with symptomatic pelvic organ prolapse of POP-Q Stage II or more, suitable for surgical repair.
- Vaginal hysterectomy and anti-incontinence procedures could be performed concurrently.
- Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires.
Who cannot join
- Previous repair of pelvic organ prolapse involving insertion of mesh.
- Experimental drug or experimental medical device within 3 months prior to the planned procedure.
- Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
- Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
- History of chemotherapy or pelvic radiation therapy.
- Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spinal cord injury or trauma).
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- Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
- Nursing or pregnant or intends future pregnancy.
- Chronic cough not well-controlled.
- BMI \≥ 30.
- In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Lan Zhu, 13911714696, zhu_julie@sina.com
Juan Chen, 8613521354364, pumchcj@sina.com
- Recruiting
Foshan Maternal and Child Health Hospital
Foshan, Guangdong, 528000
Yuling Wang, 8613049161630, wujun701121@126.com
- Recruiting
Affiliated Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Zhijun Xia, 8613840118800, xiazhijunhosp2@sina.com
- Recruiting
The third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Luwen Wang, 8613607683293, wangluwen688@sohu.com
About this study
Official title: A Prospective,Multicenter Pilot Study to Evaluate the Clinical Performance of the Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse.
Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous fascia fixation procedure is developed in China for vaginal apex fixation with native tissue.
This study is designed to determine the effectiveness and safety of ischia spinous fascia fixation procedure for the treatment of pelvic organ prolapse stage III.
Patients enrolled into the study will be followed up for up to 3 years after surgery. Evaluation will take place during surgery and postoperative visit. Stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates will be evaluated.
Read the detailed description
Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with patient's sex life. An ideal procedure for vaginal apical support should provide a durable suspension, have minimal complications, and not affect sexual or visceral function.
Ischia spinous fascia fixation procedure is developed in China. It is a transvaginal procedure used for restoring the vaginal apex support with native tissue. Clinical practice showed that it was safe, efficient and cost-effective. Recurrent rate after 1 year follow-up was about 10%, and quality of life improved significantly from the baseline.
The purpose of this multicenter, prospective study is to evaluate the effectiveness and safety of this procedure in the treatment of symptomatic pelvic organ prolapse.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- ISFF
- Keywords
- pelvic organ prolapse
- 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.
ISFFProcedure or surgery
Ischia spinous fascia fixation surgery was performed on patient with pelvic organ prolapse.
| Study group | Role | What they receive |
|---|---|---|
| ISFF | Experimental | The patients performed ischia spinous fascia fixation surgery. Receives: Procedure: ISFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical improvement according to POP-Q Score
Measured: 6 weeks
Anatomical improvement according to POP-Q Score
Measured: 1 year
Anatomical improvement according to POP-Q Score
Measured: 2 years
Anatomical improvement according to POP-Q Score
Measured: 3 years
Secondary outcomes (1)
Hospital data including operative time, estimated blood loss, length of stay, postoperative mortality, time of voiding recovery
Measured: At discharge, an expected average of 5 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2017 (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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan Zhu, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760603
- Sponsor's protocol ID
- pumch-gyn-04
- Status last verified
- Dec 2012
- First submitted
- 25 Dec 2012
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective,Multicenter Pilot Study to Evaluate the Clinical Performance of the Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse.
- ClinicalTrials.gov ID
- NCT01760603
- Acronym / sponsor ID
- pumch-gyn-04
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Jan 2013 (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.
Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous fascia fixation procedure is developed in China for vaginal apex fixation with native tissue.
This study is designed to determine the effectiveness and safety of ischia spinous fascia fixation procedure for the treatment of pelvic organ prolapse stage III.
Patients enrolled into the study will be followed up for up to 3 years after surgery. Evaluation will take place during surgery and postoperative visit. Stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates will be evaluated.
Detailed description
Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with patient's sex life. An ideal procedure for vaginal apical support should provide a durable suspension, have minimal complications, and not affect sexual or visceral function.
Ischia spinous fascia fixation procedure is developed in China. It is a transvaginal procedure used for restoring the vaginal apex support with native tissue. Clinical practice showed that it was safe, efficient and cost-effective. Recurrent rate after 1 year follow-up was about 10%, and quality of life improved significantly from the baseline.
The purpose of this multicenter, prospective study is to evaluate the effectiveness and safety of this procedure in the treatment of symptomatic pelvic organ prolapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ISFF | Experimental | Procedure: ISFFThe patients performed ischia spinous fascia fixation surgery. |
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)
- Candidates with symptomatic pelvic organ prolapse of POP-Q Stage II or more, suitable for surgical repair.
- Vaginal hysterectomy and anti-incontinence procedures could be performed concurrently.
- Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires.
Key exclusion criteria (11 listed)
- Previous repair of pelvic organ prolapse involving insertion of mesh.
- Experimental drug or experimental medical device within 3 months prior to the planned procedure.
- Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
- Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
- History of chemotherapy or pelvic radiation therapy.
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 |
|---|---|---|
| ISFFIschia spinous fascia fixation surgery was performed on patient with pelvic organ prolapse. | Procedure or surgery | ISFF |
Primary outcome
Anatomical improvement according to POP-Q Score
Time frame: 6 weeks
Anatomical improvement according to POP-Q Score
Time frame: 1 year
Anatomical improvement according to POP-Q Score
Time frame: 2 years
Anatomical improvement according to POP-Q Score
Time frame: 3 years
1 secondary outcome
Hospital data including operative time, estimated blood loss, length of stay, postoperative mortality, time of voiding recovery
Time frame: At discharge, an expected average of 5 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
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i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
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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.
Lan Zhu principal investigator
Peking Union Medical College Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISFF in people with Pelvic Organ Prolapse, run by Peking Union Medical College Hospital at 4 sites 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 11 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 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Lan Zhu (8613911714696, zhu_julie@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical improvement according to POP-Q Score (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 4 Jan 2013.