Pragmatic Evaluation of Performance and Safety of the Anchorsure® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women

Prolapse; Female Clinical Trial

— APAS  

Official title:

APAS Study: Pragmatic Evaluation of the Performance and Safety of the Anchorsure System® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women. A Post-market Multicentre Prospective Observational Cohort Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05836844
• Other study ID #: IDIL/2022/RdT01 2023-A00289-36
• Status: Recruiting
• Start date: May 11, 2023
• Est. completion date: June 1, 2028

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Renaud de TAYRAC, Professor
• Phone: +334 66 68 32 16
• Email: renaud.detayrac[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 1, 2028
• Est. primary completion date: November 1, 2024
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Women with pelvic organ prolapse with leading edge at or beyond the hymen as confirmed by the pelvic organ prolapse quantification system (POP-Q), i.e. Ba = -1 cm for the anterior compartment, and/or Bp = -1 cm for the posterior compartment, and/or C = -1 cm for the apical compartment including recurrence.

• Women due for POP surgery using the Anchorsure System® for apical prolapse suspension with or without concomitant native tissue repair, with or without concomitant hysterectomy and with or without concomitant sling for stress urinary incontinence.

• All women who have not indicated any objection to participating in the study.

• All women who have been correctly informed.

Exclusion Criteria:

• Patient taking part or having taken part in a device or drug interventional study within the last three months (except for VIGI-MESH national registry).

• Patients due for pelvic organ prolapse repair without apical suspension or with anything other than native tissue repair and the Anchorsure System®.

• Patients with uncontrolled diabetes mellitus.

• Patients with active non-controlled or chronic gynaecologic or urinary tract infection and/or local tissue necrosis.

• Patients with ongoing pelvic organ cancer (e.g. uterine, ovarian, bladder, cervix …).

• Patients with a history of radiotherapy in the pelvic area.

• Patients on therapy with immunosuppressive or immunomodulatory treatment within the previous month.

• patients under ongoing oral anticoagulant therapy.

• Patients with stage 0 and 1 pelvic organ prolapse at the time of surgery

• Patients with a preoperative infection contraindicating the surgery

Related Conditions & MeSH terms

• Prolapse
• Prolapse; Female

Intervention

Device:
• The Anchorsure System®
Sacrospinous ligament fixation performed with the Anchorsure Device

Locations

Country	Name	City	State
France	La Rochelle General Hospital	La Rochelle
France	Lille University Hospital	Lille
France	Kremlin-Bicêtre Hospital	Paris
France	Clinique Sainte-Anne	Strasbourg

Sponsors (5)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	Centre Hospitalier de La Rochelle, Clinique Sainte-Anne, Strasbourg, Kremlin-Bicetre Hospital, Paris, University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful performance after sacrospinous fixation of the Anchorsure System®.	YES /NO	12 months after fixation
Secondary	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;	Day 0 to Day 30
Secondary	Device or procedure-related adverse events: Anchor palpability	The anchor palpability score will be recorded regularly for up to 36 months after surgery.	36 months after surgery
Secondary	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).	36 months after surgery
Secondary	Type of sacrospinous fixation technique used	The type of sacrospinous fixation technique used: uni/bilateral, anterior/posterior will be recorded	Day 0
Secondary	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.	36 months after surgery
Secondary	Complications/adverse events	Collection of all complications/adverse events up to 36 months after surgery.	36 months after surgery
Secondary	Severity of adverse events	Determination of the level of severity of the adverse event: mild, moderate, severe.	36 months after surgery
Secondary	Compartments treated	Compartments treated: anterior, apical, posterior, total; type of sacrospinous suspension: uni/bilateral, anterior/posterior.	36 months after surgery
Secondary	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	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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	Day 0
Secondary	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.	Day 0
Secondary	Potential risk factors for the occurrence of complications: Age	The patient's age will be recorded in years	Day 0
Secondary	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.	Day 0
Secondary	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).	Day 0
Secondary	Potential risk factors for the occurrence of complications: Sexual intercourse.	The frequency of the patient's sexual intercourse will be recorded.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Up to 36 months after surgery.
Secondary	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 consists´ of 7 questions and 3 columns, with each question addressing the impact of urinary symptoms, digestive symptoms, and symptoms directly related to prolapse.	Day 0
Secondary	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 consists´ of 7 questions and 3 columns, with each question addressing the impact of urinary symptoms, digestive symptoms, and symptoms directly related to prolapse.	Up to 36 months after surgery.
Secondary	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.	Day 0
Secondary	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.	Up to 36 months after surgery.
Secondary	Patient satisfaction	Patient satisfaction will be recorded on a Visual Analog Scale with scores ranging from 0= Extremely Dissatisfied to 6= Extremely Satisfied.	Up to 36 months after surgery.
Secondary	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	Up to 36 months after surgery
Secondary	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	Up to 36 months