Anchorsure Versus Capio for Sacrospinous Ligament Fixation

• ClinicalTrials.gov Identifier: NCT03565640
• Recruitment Status: Completed
• First Posted: June 21, 2018
• Last Update Posted: March 7, 2022
• Sponsor: Wake Forest University Health Sciences
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Study Description

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, 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 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.
• Actual Study Start Date: October 29, 2018
• Actual Primary Completion Date: January 26, 2022
• Actual Study Completion Date: January 26, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in Buttock and Posterior Thigh Pain [ Time Frame: postoperative day 1, 7, week 6, and 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 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, and 12 month 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, and 12 month 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, week 6, and 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
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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, North Carolina

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University Health Sciences

Investigators

• Principal Investigator: Catherine Matthews, MD; Wake Forest University Health Sciences

  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:

Study Protocol and Statistical Analysis Plan  [PDF] June 9, 2021

Informed Consent Form  [PDF] June 9, 2021

More Information

Additional Information:

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 

KAPLAN E. 2015 IUGA Annual Meeting, NICE. Non-Discussed Poster #NDP295: ANCHORSURE - ANCHORING SYSTEM: OUTCOMES AND SAFETY PROFILE IN VAGINAL RECONSTRUCTIVE SURGERY 

Salicrú S. 2018 IUGA Annual Meeting, Vienna. Unmoderated Poster #503: Surgical repair of severe prolapse with Surelift System 

Publications:

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.

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.

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.

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.

Bump RC, Mattiasson A, Bø 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.

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.

DeLancey JO. Anatomic aspects of vaginal eversion after hysterectomy. Am J Obstet Gynecol. 1992 Jun;166(6 Pt 1):1717-24; discussion 1724-8.

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.

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.

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.

Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1:S17-24. Epub 2005 Dec 1. Review.

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. Review.

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. Epub 2007 Jun 20. Erratum in: Int Urogynecol J Pelvic Floor Dysfunct. 2014 Oct;25(10):1447. DeLancey, James O L [corrected to DeLancey, John O L].

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.

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.

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.

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.

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.

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.

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. Epub 2006 Mar 30.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT03565640
• Other Study ID Numbers: IRB00051211
• First Posted: June 21, 2018
• Last Update Posted: March 7, 2022
• Last Verified: September 2021

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• 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; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations