Clinical trial NCT03565640: Anchorsure Versus Capio for Sacrospinous Ligament Fixation
Official title: Randomized Trial Comparing Anchorsure® Suture Anchoring System and the CapioTM Slim Suture Capturing Device for Sacrospinous Ligament Suspension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Buttock pain
Thigh pain
Sacrospinous ligament fixation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 48
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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, 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.

Eligibility 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

Primary outcomes:
measure: Change in Buttock and Posterior Thigh Pain
timeFrame: postoperative 12 month
Secondary outcomes:
measure: POP-Q Stage Score
timeFrame: at 12 MONTHS
measure: Change in Pelvic Flore Disability Index - 20 (PFDI-20) Scores From Baseline to 12 Months
timeFrame: Baseline and Month 12
measure: Change in Symptomatic Success - PFIQ-7 Scores
timeFrame: Baseline and Month 12
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Catherine Matthews, MD
role: PRINCIPAL_INVESTIGATOR
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