Anchorsure Versus Capio for Sacrospinous Ligament Fixation
NCT ID: NCT03565640
Last Updated: 2023-02-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2018-10-29
2022-01-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Capio Slim Device
Participants will be randomized to the sacrospinous ligament fixation with use of Capio Slim 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.
Anchorsure Device
Participants will be randomized to the sacrospinous ligament fixation with use of Anchorsure 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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
FEMALE
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Catherine Matthews, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Countries
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References
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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. doi: 10.1016/s0029-7844(01)01378-3.
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.
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. doi: 10.1016/j.ajog.2004.12.025.
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, 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.
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.
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.
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. doi: 10.1016/s0885-3924(03)00162-3.
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(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.
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.
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.
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.
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. doi: 10.1016/j.ajog.2006.01.057. 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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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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
Other Identifiers
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IRB00051211
Identifier Type: -
Identifier Source: org_study_id
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