Anchorsure Versus Capio for Sacrospinous Ligament Fixation

NCT03565640 | Completed Results FDA Device

• 1 other identifier: IRB00051211
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Buttock pain; Thigh pain; Sacrospinous ligament fixation

Outcome Measures

Primary Outcomes (1)

• Change in Buttock and Posterior Thigh Pain

  This will be assessed using the numeric rating scale (NRS). The score is 0-10, with higher scores denoting a greater degree of pain.

  postoperative 12 month

Secondary Outcomes (3)

• POP-Q Stage Score

  at 12 MONTHS

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

  Baseline and Month 12

• Change in Symptomatic Success - PFIQ-7 Scores

  Baseline and Month 12

Study Arms (2)

Capio Slim Device

ACTIVE COMPARATOR

Participants will be randomized to the sacrospinous ligament fixation with use of Capio Slim Device

Device: Capio Slim Device

Anchorsure Device

EXPERIMENTAL

Participants will be randomized to the sacrospinous ligament fixation with use of Anchorsure Device

Device: Anchorsure Device

Interventions

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.

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.

Anchorsure Device

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Must have biological female reproductive organs.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (22)

• Barber MD, Chen Z, Lukacz E, Markland A, Wai C, Brubaker L, Nygaard I, Weidner A, Janz NK, Spino C. Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Neurourol Urodyn. 2011 Apr;30(4):541-6. doi: 10.1002/nau.20934. Epub 2011 Feb 22.

  PMID: 21344495 BACKGROUND

• Atherton MJ, Daborn JP, Tsokos N, Jeffery JT, Yin MJ. Complications associated with tissue anchor migration after vaginal surgery using the tissue fixation system - a case series. Aust N Z J Obstet Gynaecol. 2012 Feb;52(1):83-6. doi: 10.1111/j.1479-828X.2011.01383.x. Epub 2011 Dec 6.

  PMID: 22141331 BACKGROUND

• Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.

  PMID: 16021067 BACKGROUND

• Brennand EA, Bhayana D, Tang S, Birch C, Murphy M, Cenaiko D, Ross S, Robert M. Anchor placement and subsequent movement in a mesh kit with self-fixating tips: 6-month follow-up of a prospective cohort. BJOG. 2014 Apr;121(5):634-40. doi: 10.1111/1471-0528.12536. Epub 2014 Jan 13.

  PMID: 24621073 BACKGROUND

• Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)70243-0.

  PMID: 8694033 BACKGROUND

• Cepeda MS, Africano JM, Polo R, Alcala R, Carr DB. What decline in pain intensity is meaningful to patients with acute pain? Pain. 2003 Sep;105(1-2):151-7. doi: 10.1016/s0304-3959(03)00176-3.

  PMID: 14499431 BACKGROUND

• DeLancey JO. Anatomic aspects of vaginal eversion after hysterectomy. Am J Obstet Gynecol. 1992 Jun;166(6 Pt 1):1717-24; discussion 1724-8. doi: 10.1016/0002-9378(92)91562-o.

  PMID: 1615980 BACKGROUND

• Eilber KS, Alperin M, Khan A, Wu N, Pashos CL, Clemens JQ, Anger JT. Outcomes of vaginal prolapse surgery among female Medicare beneficiaries: the role of apical support. Obstet Gynecol. 2013 Nov;122(5):981-987. doi: 10.1097/AOG.0b013e3182a8a5e4.

  PMID: 24104778 BACKGROUND

• Farrar JT, Berlin JA, Strom BL. Clinically important changes in acute pain outcome measures: a validation study. J Pain Symptom Manage. 2003 May;25(5):406-11. doi: 10.1016/s0885-3924(03)00162-3.

  PMID: 12727037 BACKGROUND

• Ferrando CA, Walters MD. A randomized double-blind placebo-controlled trial on the effect of local analgesia on postoperative gluteal pain in patients undergoing sacrospinous ligament colpopexy. Am J Obstet Gynecol. 2018 Jun;218(6):599.e1-599.e8. doi: 10.1016/j.ajog.2018.03.033. Epub 2018 Mar 31.

  PMID: 29614274 BACKGROUND

• Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.

  PMID: 16320034 BACKGROUND

• Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.

  PMID: 21621130 BACKGROUND

• Hsu Y, Chen L, Summers A, Ashton-Miller JA, DeLancey JO. Anterior vaginal wall length and degree of anterior compartment prolapse seen on dynamic MRI. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Jan;19(1):137-42. doi: 10.1007/s00192-007-0405-x. Epub 2007 Jun 20.

  PMID: 17579801 BACKGROUND

• Inoue H, Sekiguchi Y, Kohata Y, Satono Y, Hishikawa K, Tominaga T, Oobayashi M. Tissue fixation system (TFS) to repair uterovaginal prolapse with uterine preservation: a preliminary report on perioperative complications and safety. J Obstet Gynaecol Res. 2009 Apr;35(2):346-53. doi: 10.1111/j.1447-0756.2008.00947.x.

  PMID: 19708181 BACKGROUND

• Karacaoglu MU, Ozyurek ES, Mutlu S, Odacilar E. Unilateral sacrospinous ligament fixation (USLF) with a mesh stabilizing anchor set: clinical outcome and impact on quality of life. Clin Exp Obstet Gynecol. 2016;43(2):216-9.

  PMID: 27132413 BACKGROUND

• Maher CF, Murray CJ, Carey MP, Dwyer PL, Ugoni AM. Iliococcygeus or sacrospinous fixation for vaginal vault prolapse. Obstet Gynecol. 2001 Jul;98(1):40-4. doi: 10.1016/s0029-7844(01)01378-3.

  PMID: 11430954 BACKGROUND

• Mowat A, Wong V, Goh J, Krause H, Pelecanos A, Higgs P. A descriptive study on the efficacy and complications of the Capio (Boston Scientific) suturing device for sacrospinous ligament fixation. Aust N Z J Obstet Gynaecol. 2018 Feb;58(1):119-124. doi: 10.1111/ajo.12720. Epub 2017 Sep 22.

  PMID: 28940223 BACKGROUND

• Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.

  PMID: 20966694 BACKGROUND

• Stanford EJ, Moore RD, Roovers JP, Courtieu C, Lukban JC, Bataller E, Liedl B, Sutherland SE. Elevate anterior/apical: 12-month data showing safety and efficacy in surgical treatment of pelvic organ prolapse. Female Pelvic Med Reconstr Surg. 2013 Mar-Apr;19(2):79-83. doi: 10.1097/SPV.0b013e318278cc29.

  PMID: 23442504 BACKGROUND

• Summers A, Winkel LA, Hussain HK, DeLancey JO. The relationship between anterior and apical compartment support. Am J Obstet Gynecol. 2006 May;194(5):1438-43. doi: 10.1016/j.ajog.2006.01.057. Epub 2006 Mar 30.

  PMID: 16579933 BACKGROUND

• Unger CA, Walters MD. Gluteal and posterior thigh pain in the postoperative period and the need for intervention after sacrospinous ligament colpopexy. Female Pelvic Med Reconstr Surg. 2014 Jul-Aug;20(4):208-11. doi: 10.1097/SPV.0000000000000091.

  PMID: 24978086 BACKGROUND

• Plair A, Smith W, Hines K, Schachar J, Parker-Autry C, Matthews C. Gluteal and Posterior Thigh Pain From a Suture Compared With an Anchor-Based Device in Patients Undergoing Sacrospinous Ligament Fixation: A Randomized Controlled Trial. Obstet Gynecol. 2022 Jan 1;139(1):97-106. doi: 10.1097/AOG.0000000000004629.

  PMID: 34856573 DERIVED

Related Links

• FDA 2011 Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse
• SOUSA A, FLORES J, LEON J, SOUSA-GONZALEZ D. ICS 2017 Annual Meeting, Florence. Non-Discussion Video #850: RESULTS OF EFFICIENCY AND SAFETY IN REPAIRING PREVIOUS PROLAPSE THROUGH THE SURELIFT® SYSTEM. 5 YEARS RESULTS
• AMAT L, GOMEZ A, MARTINEZ E, KAPLAN E. ICS 2010 Annual Meeting, Toronto. Non-Discussion Video #864: EVALUATION OF THE SAFETY AND EFFICACY OF PELVIC ORGAN PROLAPSE REPAIR USING SURELIFT® SYSTEM - PRELIMINARY RESULTS
• LIN X, et al. 2015 IUGA Annual Meeting, Nice. Non-Discussed Poster #NDP310: SURGICAL TREATMENT OF GENITAL PROLAPSE WITH SURELIFT® MESH IN PATIENTS AT RISK OF RECURRENCE
• Salicrú S. 2018 IUGA Annual Meeting, Vienna. Unmoderated Poster #503: Surgical repair of severe prolapse with Surelift System

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sachin Vyas
• Organization: Atrium Wake Forest Baptist Health

svyas@wakehealth.edu

7865564412

Study Officials

• Catherine Matthews, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 21, 2018
• Study Start: October 29, 2018
• Primary Completion: January 26, 2022
• Study Completion: January 26, 2022
• Last Updated: February 16, 2023
• Results First Posted: February 16, 2023

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: At least 3 years from study completion
• Access Criteria: Contact the principal investigator Dr. Catherine Matthews

Locations

US (1)