ClinicalTrials.gov
ClinicalTrials.gov Menu

Anchorsure Versus Capio for Sacrospinous Ligament Fixation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03565640
Recruitment Status : Not yet recruiting
First Posted : June 21, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
Sacrospinous ligament fixation is a common method of repairing apical support for pelvic organ prolapse but it currently suffers from a high rate of postoperative buttock and posterior thigh pain. Anchorsure® is a relatively new FDA-approved device that uses an anchor instead of the widely-used suture capturing mechanism to perform sacrospinous ligament fixation. The study hypothesis is that Anchorsure® will reduce the degree and rate of buttock and posterior thigh pain compared to the widely used Capio™ Slim suturing capturing Device.

Condition or disease Intervention/treatment Phase
Postoperative Pain Device: Capio Slim Device Device: Anchorsure Device Not Applicable

Detailed Description:
Sacrospinous ligament fixation is a common method of repairing apical support for pelvic organ prolapse but it currently suffers from a high rate of postoperative buttock and posterior thigh pain. Rates of buttock and thigh pain 6 weeks after sacrospinous ligament fixation with the widely used Capio™ Slim device (Boston Scientific) are about 15-16% with immediate postoperative pain occurring in 55-84% of patients. This study is a randomized controlled single-blind study with the primary goal of investigating if there is an improvement in the intensity and rate of buttock and posterior thigh pain 1 day, 7 days, and 6 weeks after sacrospinous ligament fixation with a new device, the Anchorsure® Suture Anchoring System (Neomedic) compared to the widely utilized Capio™ Slim (Boston Scientific) device. 60 patients will be enrolled to undergo sacrospinous ligament fixation for treatment of pelvic organ prolapse. The patients will be randomized into two study groups; one will have sacrospinous ligament fixation using the Capio™ Slim device and the other with the Anchorsure® device. The patient's pain will be recorded via the numerical rating scale (NRS), a validated pain evaluation tool. The study is powered to detect a 2.5 point difference in pain between the two groups, a value that has been shown in studies to be clinically significant to acute pain patients. Secondary outcomes of surgeon satisfaction and efficiency with the devices will be assessed via surgeon questionnaires.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Participants and research staff will be masked during the study as much as possible, however there will be a description of the type of sacrospinous ligament fixation device used within the body of the operative note for each patient that research staff could gain access to
Primary Purpose: Supportive Care
Official Title: Randomized Trial Comparing Anchorsure® Suture Anchoring System and the CapioTM Slim Suture Capturing Device for Sacrospinous Ligament Suspension.
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Active Comparator: Capio Slim Device
Participants will be randomized to the sacrospinous ligament fixation with use of Capio Slim Device
Device: Capio Slim Device
Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Capio Slim Device.

Experimental: Anchorsure Device
Participants will be randomized to the sacrospinous ligament fixation with use of Anchorsure Device
Device: Anchorsure Device
Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Anchorsure Device.




Primary Outcome Measures :
  1. Change in Buttock and Posterior Thigh Pain [ Time Frame: postoperative day 1, 7, and week 6 ]
    This will be assessed using the numeric rating scale (NRS). The score is 0-10, with higher scores denoting a greater degree of pain.


Secondary Outcome Measures :
  1. Surgical Anatomic Success [ Time Frame: at week 6 ]
    POP-Q assessment will be performed with surgical success being defined as apical descent less than 50% of total vaginal length.

  2. Surgeon satisfaction [ Time Frame: postoperative day 0 ]
    Surgeon satisfaction with application of surgical device will be assessed via a 5-point rating scale (very dissatisfied, somewhat dissatisfied, neutral, satisfied, very satisfied).

  3. Surgical efficiency [ Time Frame: intraoperative ]
    Surgical efficiency will be assessed as continuous data measured as a means in minutes.

  4. Symptomatic success- PFDI-20 [ Time Frame: at week 6 postoperative ]
    Symptomatic success will be assessed by the pelvic floor disability index (PFDI-20) questionnaire. The PFDI-20 has 20 items within 3 scales of symptoms (total of 20 items). Each item produces a response of 0 to 4, the average response in each scale is multiplied by 25 to obtain the scale score (range 0 to 100). The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother.

  5. Symptomatic success- PFIQ-7 [ Time Frame: at week 6 postoperative ]
    Symptomatic success will be assessed by the pelvic floor impact (PFIQ-7) questionnaire. The PFIQ-7 has 7 items for each of 3 scales (total of 21 items). Each item produces a response of 0 to 3, the average response in each scale is multiplied by 100/3 to obtain the scale score (range 0 to 100). The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother.

  6. Change in Postoperative general pelvic pain [ Time Frame: postoperative day 1, 7, and week 6 ]
    This will be assessed using the numeric rating scale (NRS). The score is 0-10, with higher scores denoting a greater degree of pain

  7. Postoperative post-hospitalization opioid use [ Time Frame: postoperative day 7 ]
    Patients will be given a diary to record the amount of opioid pain medications they use at home after their procedure until day 7. The cumulative dose of pain medication will be converted into morphine equivalents for analysis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Must have biological female reproductive organs.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients
  • At least 21 years of age
  • Surgical plan that includes a native tissue vaginal repair with apical support via sacrospinous ligament fixation. We will permit both hysteropexy and post-hysterectomy sacrospinous ligament suspension
  • Understanding and acceptance of the need to return for the 6 week follow-up visit
  • English speaking and able to give informed consent
  • Willing and able to complete all study questionnaires
  • Ambulatory

Exclusion Criteria:

  • Prior sacrospinous ligament fixation procedure.
  • Any serious disease or chronic condition that could interfere with the study compliance
  • Inability to give informed consent
  • Pregnancy or planning pregnancy prior to the 6 week postoperative visit
  • Prior pelvic radiation
  • Incarcerated
  • Prior augmented (synthetic mesh, autologous graft, xenograft, allograft) prolapse repair
  • History of significant buttock or leg pain in the past 3 months
  • History of fibromyalgia, polymyositis, dermatomyositis, systemic lupus erythematosus, or other auto-immune myalgic conditions
  • Current regular opioid drug therapy for any chronic pain condition
  • History of loss of motor or sensory function of the lower extremities
  • History of sacral decubitus ulcers
  • Planned concomitant levatorplasty; anal sphincteroplasty, anal fissurectomy, rectopexy, or hemorrhoidectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565640


Contacts
Contact: Andre R Plair, MD 336-716-4310 aplair@wakehealth.edu
Contact: Catherine Matthews, MD camatthe@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Medical Center Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Andre R Plair, MD    336-716-4310    aplair@wakehealth.edu   
Principal Investigator: Catherine Matthews, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Catherine Matthews, MD Wake Forest University Health Sciences

Additional Information:
Publications:

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03565640     History of Changes
Other Study ID Numbers: IRB00051211
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-Identified data from the study will be kept on password protected digital storage for at least three years following the project completion.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: At least 3 years from study completion
Access Criteria: Contact the principal investigator (Dr. Catherine Matthews) or project manager (Dr. Andre Plair)
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Wake Forest University Health Sciences:
Buttock pain
Thigh pain
Sacrospinous ligament fixation

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms