An observational study in Prolapse; Female, Prolapse Uterovaginal and Prolapse; Cervix, sponsored by Centre Hospitalier Universitaire de Nīmes. Recruiting at 4 sites in France. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational
Pelvic Organ Prolapse affects 50% of parous women, and apical prolapse is one of the most common types of prolapse. Treatment for apical prolapse ranges from observation, non-surgical treatment or surgical repair. An anchoring device can reduce dissection and operative time and is meant to provide strong fixation whilst minimizing potential postoperative pain by avoiding neurovascular injuries. These potential advantages must be evaluated in terms of performance and safety. This cohort study will be on patients undergoing sacrospinous fixation with the Anchorsure® system with a follow-up of 36 months.
Pelvic Organ Prolapse affects 50% of parous women, and apical prolapse is one of the most frequent. Treatment options for women with apical prolapse range from observation, non-surgical treatment or surgical repair. The use of an anchoring device reduces dissection and operative time and is supposed to provide a strong fixation while minimizing potential postoperative pain by avoiding neurovascular injuries. These potential advantages have to be evaluated in terms of performance and safety. This is a cohort study on patients undergoing sacrospinous fixation with the Anchorsure® system with a follow-up of 36 months.The primary objective of the study is to evaluate the performance of the Anchorsure System® for sacrospinous suspension 12 months after surgical treatment of women with apical prolapse in real-life settings.
93 studies on the registry are indexed under Prolapse; 9 are open to participants now.
This study's planned enrollment of 120 is below the median of 150 across 27 observational studies indexed under Prolapse.
Browse Prolapse studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.
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The target population is the population of adult women, undergoing a surgical treatment of The target population is the population of adult women, undergoing a surgical treatment for pelvic organ prolapse using Anchorsure System® in the participating centres: Nîmes University Hospital, Lille University Hospital, Sainte-Anne Clinic in Strasbourg, La Rochelle Hospital and Kremlin-Bicêtre Hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sacrospinous ligament fixation performed with the Anchorsure Device
Successful performance after sacrospinous fixation of the Anchorsure System®.
YES /NO
Time frame: 12 months after fixation
Device or procedure-related adverse events: Daily Pain score
All procedure-related adverse events and complications will be recorded using the Clavien-Dindo classification system with a one-month pain diary (filled in once a day using a visual analog scale of 0 to 10 for buttock pain;
Time frame: Day 0 to Day 30
Device or procedure-related adverse events: Anchor palpability
The anchor palpability score will be recorded regularly for up to 36 months after surgery.
Time frame: 36 months after surgery
Device or procedure-related adverse events: Abnormal findings on clinical examination
All abnormal findings on clinical examination will be reported including suture exposure, anchor extrusion into another organ, perforation, organ or vascular or nerve injury/damage, fistula, bleeding including hematoma (requiring transfusion or not), thrombotic event, neuromuscular problems (including pain), pelvic discomfort or pain, de novo dyspareunia, infection (e.g. vaginal, urinary tract infection), urinary tract complications including ureteric disorders, urinary retention requiring drainage \> 48h, urge symptoms or incontinence (worsening or de novo), de novo constipation or faecal incontinence. Incidences of adverse events will be determined overall, by type of adverse event, severity, compartment and type of sacrospinous suspension (uni versus bilateral and anterior versus posterior).
Time frame: 36 months after surgery
Type of sacrospinous fixation technique used
The type of sacrospinous fixation technique used: uni/bilateral, anterior/posterior will be recorded
Time frame: Day 0
Success of the intervention
Success is defined as per primary objective and assessed at 36 months after surgery; compartments treated: anterior, apical, posterior, total; type of prolapse: primary or recurrent prolapse.
Time frame: 36 months after surgery
Complications/adverse events
Collection of all complications/adverse events up to 36 months after surgery.
Time frame: 36 months after surgery
Severity of adverse events
Determination of the level of severity of the adverse event: mild, moderate, severe.
Time frame: 36 months after surgery
Compartments treated
Compartments treated: anterior, apical, posterior, total; type of sacrospinous suspension: uni/bilateral, anterior/posterior.
Time frame: 36 months after surgery
Potential risk factors for the success/failure of the treatment at baseline: Age
Collection of potential risk factors for the success/failure of the treatment at baseline: The patient's age will be recorded
Time frame: Day 0
Potential risk factors for the success/failure of the treatment at baseline: Body Mass Index
Collection of potential risk factors for the success/failure of the treatment at baseline: the patient's Body Mass Index will be recorded.
Time frame: Day 0
Potential risk factors for the success/failure of the treatment at baseline: Previous history of pelvic surgery
Collection of potential risk factors for the success/failure of the treatment at baseline: Any history of pelvic surgery will be recorded.
Time frame: Day 0
Potential risk factors for the success/failure of the treatment at baseline: Chronic constipation
Collection of potential risk factors for the success/failure of the treatment at baseline: Any history of chronic constipation will be recorded.
Time frame: Day 0
Potential risk factors for the success/failure of the treatment at baseline: Chronic pulmonary conditions
Collection of potential risk factors for the success/failure of the treatment at baseline: Any history of chronic pulmonary conditions will be recorded.
Time frame: Day 0
Potential risk factors for the success/failure of the treatment at baseline: Vaginal compartment
Collection of potential risk factors for the success/failure of the treatment at baseline: Details of the patient's vaginal compartment will be recorded.
Time frame: Day 0
Potential risk factors for the success/failure of the treatment at baseline: Type of prolapse
Collection of potential risk factors for the success/failure of the treatment at baseline: The type of prolapse (recurrent or primary) will be recorded.
Time frame: Day 0
Potential risk factors for the success/failure of the treatment at baseline: Pelvic organ Prolapse Q grade
Collection of potential risk factors for the success/failure of the treatment at baseline: the patient's Pelvic Organ Prolapse (POPQ) grade will be recorded as follows : Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen Stage 2 the most distal portion of the prolapse is 1 cm or less proximal or distal to the hymenal plane Stage 3 the most distal portion of the prolapse protrudes more than 1 cm below the hymen but protrudes no farther than 2 cm less than the total vaginal length (for example., not all of the vagina has prolapsed) Stage 4 vaginal eversion is essentially complete
Time frame: Day 0
Potential risk factors for the success/failure of the treatment at baseline: Concomitant surgery
Collection of potential risk factors for the success/failure of the treatment at baseline: details of any concomitant surgery will be recorded.
Time frame: Day 0
Potential risk factors for the occurrence of complications: Age
The patient's age will be recorded in years
Time frame: Day 0
Potential risk factors for the occurrence of complications: Body Mass Index
The patient's body mass index (BMI) will be calculated and recorded. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.
Time frame: Day 0
Potential risk factors for the occurrence of complications: Smoking.
The patient's smoking status will be recorded (Regular smoker/Weaned/Number of cigarettes per day/week).
Time frame: Day 0
Potential risk factors for the occurrence of complications: Sexual intercourse.
The frequency of the patient's sexual intercourse will be recorded.
Time frame: Day 0
Potential risk factors for the occurrence of complications: concomitant surgery
All details of any concomitant surgery in non-target compartment, other concomitant surgery i.e. hysterectomy, mid uretral sling for SUI, etc…will be recorded.
Time frame: Day 0
Evolution of the PFDI-20 quality of life score
The Pelvic Floor Distress inventory (PFDI) includes 20 questions. Each question begins with a "yes" or "no" response. If "yes," the patient must indicate how much bowl, bladder, or pelvic symptoms have been bothering them in the past 3 months on a 4-point scale that ranges from "not at all" (0) to "quite a bit" (4). The scale scores are found individually by calculating the mean value of their corresponding questions and then multiplying by 25 to obtain a value that ranges from 0 to 100. The sum of the 3 scales are added together to get the PFDI-20 summary score, which ranges from 0 to 300.
Time frame: Day 0
Evolution of the PFDI-20 quality of life score
The Pelvic Floor Distress inventory (PFDI) includes 20 questions. Each question begins with a "yes" or "no" response. If "yes," the patient must indicate how much bowl, bladder, or pelvic symptoms have been bothering them in the past 3 months on a 4-point scale that ranges from "not at all" (0) to "quite a bit" (4). The scale scores are found individually by calculating the mean value of their corresponding questions and then multiplying by 25 to obtain a value that ranges from 0 to 100. The sum of the 3 scales are added together to get the PFDI-20 summary score, which ranges from 0 to 300.
Time frame: Up to 36 months after surgery.
Evolution of quality of life scores : PFIQ-7
The Pelvic Floor Impact Questionnaire-7 (PFIQ-7), a shortened, less comprehensive version of the Pelvic Floor Impact Questionnaire (PFIQ), is a questionnaire about the social impact of the patient's pelvic floor disorders. It consistś of 7 questions and 3 columns, with each question addressing the impact of urinary symptoms, digestive symptoms, and symptoms directly related to prolapse.
Time frame: Day 0
Evolution of quality of life scores : PFIQ-7
The Pelvic Floor Impact Questionnaire-7 (PFIQ-7), a shortened, less comprehensive version of the Pelvic Floor Impact Questionnaire (PFIQ), is a questionnaire about the social impact of the patient's pelvic floor disorders. It consistś of 7 questions and 3 columns, with each question addressing the impact of urinary symptoms, digestive symptoms, and symptoms directly related to prolapse.
Time frame: Up to 36 months after surgery.
Evolution of quality of life scores : PISQ-IR
The Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, Revised by the International UroGynocological Association (PISQ-IR) is a disease-specific tool for evaluating the sexual function in women with pelvic floor disorders. It is useful in screening for sexual disorders in women with Urinary Incontinence (UI), pelvic organ prolapse (POP), and anal incontinence. It is used to assess the impact of pelvic floor disorders on female sexual activity and inactivity.
Time frame: Day 0
Evolution of quality of life scores : PISQ-IR
The Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, Revised by the International UroGynocological Association (PISQ-IR) is a disease-specific tool for evaluating the sexual function in women with pelvic floor disorders. It is useful in screening for sexual disorders in women with Urinary Incontinence (UI), pelvic organ prolapse (POP), and anal incontinence. It is used to assess the impact of pelvic floor disorders on female sexual activity and inactivity.
Time frame: Up to 36 months after surgery.
Patient satisfaction
Patient satisfaction will be recorded on a Visual Analog Scale with scores ranging from 0= Extremely Dissatisfied to 6= Extremely Satisfied.
Time frame: Up to 36 months after surgery.
Global impression of improvement (PGI-I)
The Patient Global impression of improvement (PGI-I) is a scale to describes how the patient's post-operative condition is compared with how it was before surgery: Very much better = 1, Much better = 2, A little better = 3, No change = 4, A little worse = 5, Much worse = 6, Very much worse = 7
Time frame: Up to 36 months after surgery
Frequency of revision and/or surgical re-intervention
The frequency of revision and/or surgical re-intervention including anti-incontinence surgery after sacrospinous suspension will be recorded
Time frame: Up to 36 months
Ran from May 2023 to primary completion in Oct 2024, 16 months.
Of 14 observational studies under Prolapse, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 58. This study's 16 months is below that.
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