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Completed

NCT Number: NCT03565640

Anchorsure Versus Capio for Sacrospinous Ligament Fixation

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

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, 6 weeks, and minimum 12 months 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capio Slim Device

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.

Anchorsure Device

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 outcomes

  1. Change in Buttock and Posterior Thigh Pain

    Time frame: postoperative 12 month

    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 outcomes

  1. POP-Q Stage Score

    Time frame: at 12 MONTHS

    The stage is assigned as follows: 0 if there is no prolapse at all, 1 if there is prolapse but the leading point is not within 1cm of the hymen, 2 if the leading point is within 1 cm of the hymen (from 1cm within the hymen to 1cm beyond the hymen), 3 if the leading point is more than 1cm from the hymen but less than 2cm from being completely prolapsed, and 4 if the leading point is within 2cm of being complete prolapsed. Therefore higher POP-Q stages correlate to a worse degree of prolapse than lower POP-Q stages.

  2. Change in Pelvic Flore Disability Index - 20 (PFDI-20) Scores From Baseline to 12 Months

    Time frame: Baseline and Month 12

    Symptomatic success was assessed by the pelvic floor disability index (PFDI-20) questionnaire. The PFDI-20 has 20 items within 3 sub-scales of symptoms (total of 20 items). Each item produces a response of 0 to 4, the average response in each sub-scale is multiplied by 25 to obtain the sub-scale score (range 0 to 100). The total score is the sum of the three sub-scale scores with a range of 0-300. Higher value for a time-point score indicates a greater degree of symptom bother.

    The difference in scores across the study time-points was calculated by subtracting the total score at baseline from the score at 12 months post-operation. A negative value for the difference in scores from baseline to 12 months indicates symptom improvement, where the more negative the difference in score is the greater the improvement in symptoms.

  3. Change in Symptomatic Success - PFIQ-7 Scores

    Time frame: Baseline and Month 12

    Symptomatic success will be assessed by the Pelvic Floor Impact Questionnaire - 7 (PFIQ-7). The PFIQ-7 has 7 items for each of 3 sub-scales (total of 21 items). Each item produces a response of 0 to 3, the average response in each sub-scale is multiplied by 100/3 to obtain the total scale score (range 0 to 100). The total score is the sum of the three sub-scale scores with a range of 0-300. Higher value for a time-point score indicates a greater degree of symptom bother.

    The difference in scores across the study time-points was calculated by subtracting the total score at baseline from the score at 12 months post-operation. A negative value for the difference in scores from baseline to 12 months indicates symptom improvement, where the more negative the difference in score is the greater the improvement in symptoms.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Randomized Trial Comparing Anchorsure® Suture Anchoring System and the CapioTM Slim Suture Capturing Device for Sacrospinous Ligament Suspension.

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 21, 2018
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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