Apical ProlapseSPIPNCT03911778
Evolution of Symptoms After Sacrospinofixation With Posterior Isthmic Band
An observational study of Apical Prolapse, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Prolapse is a condition that can cause disabling pelvic, urinary or sexual function disorders and impaired quality of life. Regarding the prolapse of the middle floor, the vaginal sacrospinofixation according to Richter is the reference technique for the suspension of the vaginal fundus. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Apical Prolapse
- What is being tested?
- Improvement of symptoms
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2019to 15 Nov 2023
- Phase
- Observational
- 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
Study population: Patients with apical symptomatic prolapse ≥ II in the Pelvic Organ Prolapse Quantification (POP-Q) classification and for whom sacrospinofixation with posterior isthmic Bilateral Sacrospinous Colposuspension (BSC) Mesh is planned
Who may be able to join
- women over 18
- apical prolapse requiring surgical correction of grade II or greater in the Pelvic Organ Prolapse Quantification (POP-Q) classification
- patients who wish an intervention because of the discomfort caused by prolapse
- sacrospinofixation procedure with posterior isthmic band Bilateral Sacrospinous Colposuspension (BSC) Mesh provided
- person having expressed his non-opposition
Who cannot join
- apical prolapse of stage < II in the Pelvic Organ Prolapse Quantification (POP-Q) classification, and prolapse without functional discomfort
- disorders leading to an unacceptable risk of postoperative complications sought during the interrogation of the patient (disorders of blood coagulation, disorders of the immune system, progressive diseases ....)
- reduced mobility of the lower limbs (not allowing positioning for surgery)
- pregnancy or any plans for pregnancy during the study period
- evolutionary or latent infection
- known hypersensitivity to polypropylene
- inability to understand the information given
- person deprived of liberty, under guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of the Evolution of Symptoms After Sacrospinofixation With Posterior Isthmic Band
Prolapse is a condition that can cause disabling pelvic, urinary or sexual function disorders and impaired quality of life.
Regarding the prolapse of the middle floor, the vaginal sacrospinofixation according to Richter is the reference technique for the suspension of the vaginal fundus. But the technique of sacrospinofixation vaginally is not without several difficulties in the short term but also in the medium and long term.
Read more
Recently, anchoring devices have been developed to limit the dissection of the sacrospinous ligament and the operative exposure by the sometimes traumatic valves.
The investigating team uses a technical variant in the form of an isthmic posterior strip of light weight and whose arms are sutured to the sacrospinous ligaments. The advantages of this isthmic strip are based on its small size, its very low basis weight and its wide mesh (improvement of tolerance) via a mini-invasive vaginal approach (thus allowing ambulatory care).
Patient functional discomfort is the main problem related to the presence of a prolapse, therefore, the researchers wish to evaluate patient feelings following the use of this isthmic band. The researchers' hypothesis is that the sacrospinofixation technique with posterior isthmic band Bilateral Sacrospinous Colposuspension (BSC) Mesh (Agency for Medical Innovations (AMI) laboratory) improves symptoms experienced by patients with mid-level prolapse.
- Conditions
- Apical Prolapse
- Being tested
- Improvement of symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improvement of symptomsOther
Improvement of symptoms on the Patient Global Impression of Improvement Index (PGI-I) scale (score 1, 2, or 3) at 6 weeks postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Sacrospinofixation | Patients with apical symptomatic prolapse ≥ II in the POP-Q classification and for whom sacrospinofixation with posterior isthmic BSC Mesh is planned Receives: Other: Improvement of symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of symptoms
Percentage of patients with improvement of their symptoms on the Patient Global Impression of Improvement Index (PGI-I) scale (score 1, 2, or 3)
Measured: 6 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start2 Sep 2019
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical ProlapseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gautier CHENE, Ph.D., Principal investigator, Hospices Civils de Lyon, Hôpital Femme Mère Enfant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911778
- Sponsor's protocol ID
- 69HCL19_0256
- Other IDs
- 2019-A01044-53
- Acronym
- SPIP
- Status last verified
- Jan 2023
- First submitted
- 10 Apr 2019
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Evolution of Symptoms After Sacrospinofixation With Posterior Isthmic Band
- ClinicalTrials.gov ID
- NCT03911778
- Acronym / sponsor ID
- SPIP / 69HCL19_0256
- Conditions
- Apical Prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 11 Apr 2019 (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.
Prolapse is a condition that can cause disabling pelvic, urinary or sexual function disorders and impaired quality of life.
Regarding the prolapse of the middle floor, the vaginal sacrospinofixation according to Richter is the reference technique for the suspension of the vaginal fundus. But the technique of sacrospinofixation vaginally is not without several difficulties in the short term but also in the medium and long term.
Recently, anchoring devices have been developed to limit the dissection of the sacrospinous ligament and the operative exposure by the sometimes traumatic valves.
The investigating team uses a technical variant in the form of an isthmic posterior strip of light weight and whose arms are sutured to the sacrospinous ligaments. The advantages of this isthmic strip are based on its small size, its very low basis weight and its wide mesh (improvement of tolerance) via a mini-invasive vaginal approach (thus allowing ambulatory care).
Patient functional discomfort is the main problem related to the presence of a prolapse, therefore, the researchers wish to evaluate patient feelings following the use of this isthmic band. The researchers' hypothesis is that the sacrospinofixation technique with posterior isthmic band Bilateral Sacrospinous Colposuspension (BSC) Mesh (Agency for Medical Innovations (AMI) laboratory) improves symptoms experienced by patients with mid-level prolapse.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacrospinofixation | – | Other: Improvement of symptomsPatients with apical symptomatic prolapse ≥ II in the POP-Q classification and for whom sacrospinofixation with posterior isthmic BSC Mesh is planned |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with apical symptomatic prolapse ≥ II in the Pelvic Organ Prolapse Quantification (POP-Q) classification and for whom sacrospinofixation with posterior isthmic Bilateral Sacrospinous Colposuspension (BSC) Mesh is planned
Key inclusion criteria (5 listed)
- women over 18
- apical prolapse requiring surgical correction of grade II or greater in the Pelvic Organ Prolapse Quantification (POP-Q) classification
- patients who wish an intervention because of the discomfort caused by prolapse
- sacrospinofixation procedure with posterior isthmic band Bilateral Sacrospinous Colposuspension (BSC) Mesh provided
- person having expressed his non-opposition
Key exclusion criteria (8 listed)
- apical prolapse of stage < II in the Pelvic Organ Prolapse Quantification (POP-Q) classification, and prolapse without functional discomfort
- disorders leading to an unacceptable risk of postoperative complications sought during the interrogation of the patient (disorders of blood coagulation, disorders of the immune system, progressive diseases ....)
- reduced mobility of the lower limbs (not allowing positioning for surgery)
- pregnancy or any plans for pregnancy during the study period
- evolutionary or latent infection
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 |
|---|---|---|
| Improvement of symptomsImprovement of symptoms on the Patient Global Impression of Improvement Index (PGI-I) scale (score 1, 2, or 3) at 6 weeks postoperatively | Other | Sacrospinofixation |
Primary outcome
Improvement of symptoms
Time frame: 6 weeks postoperatively
Percentage of patients with improvement of their symptoms on the Patient Global Impression of Improvement Index (PGI-I) scale (score 1, 2, or 3)
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 11 Jan 2024.
Related trials for Apical Prolapse
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Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
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Comparison of the Effectiveness and Learning Curve of Laparoscopic Pectopexy Versus Laparoscopic Sacrocolpopexy
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To Explore the Surgical Outcomes and Safety of an Innovative Laparoscopic Uterine Pectopexy Technique Using Inverted T-meshes for Simultaneous Apical and Anterior Vaginal Repair.
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Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study
Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery
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.
Gautier CHENE, Ph.D. principal investigator
Hospices Civils de Lyon, Hôpital Femme Mère Enfant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apical Prolapse, run by Hospices Civils de Lyon at 1 site in France.
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 8 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 11 Jan 2024. 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 France. 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?
Improvement of symptoms (time frame: 6 weeks postoperatively). 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 11 Jan 2024.