N/A N=47 Randomized Single-blind Supportive Care

Anchorsure Versus Capio for Sacrospinous Ligament Fixation

Postoperative Pain

Bottom Line

View on ClinicalTrials.gov: NCT03565640 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2023

Primary outcome: Primary: Change in Buttock and Posterior Thigh Pain — -0.5; -0.2; -1.8; -1.5 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Capio Slim Device (Device); Anchorsure Device (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: Female
Sponsor: Wake Forest University Health Sciences
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Buttock and Posterior Thigh Pain	-0.5; -0.2; -1.8; -1.5	—
SECONDARY POP-Q Stage Score	0.8; 0.9	—
SECONDARY Change in Pelvic Flore Disability Index - 20 (PFDI-20) Scores From Baseline to 12 Months	-66.3; -71.0	—
SECONDARY Change in Symptomatic Success - PFIQ-7 Scores	-26.4; -40.6	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03565640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.