Colpopexy and Urinary Reduction Efforts (CARE) Protocol (CARE)
9 januari 2011 bijgewerkt door: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CARE: A Randomized Trial of Colpopexy and Urinary Reduction Efforts
Pelvic organ prolapse occurs when the muscles holding pelvic organs (e.g., the uterus or bladder) weaken and the organs fall or slide down into the vagina.
Pelvic organ prolapse can be corrected with surgery.
However, women who have this surgery may develop urinary incontinence.
This study will determine how doctors can predict this problem and whether an additional surgical procedure at the time of prolapse surgery can prevent the development of urinary incontinence.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
Many women have surgery for pelvic organ prolapse (cystocele, uterine prolapse, rectocele). Women with advanced pelvic organ prolapse may experience stress urinary incontinence following surgery to repair the prolapse. Development of incontinence is unpredictable. This study will determine which, if any, clinical tests are useful for predicting post-operative urinary incontinence. The study will also determine if a Burch urethropexy should be performed routinely or selectively at the time of sacrocolpopexy in continent women.
Women with pelvic organ prolapse who are scheduled for prolapse repair will be randomized to a Burch urethropexy group or to a control group. Women in the Burch group will undergo urethropexy at the time of prolapse repair. Assessments will include a quality of life telephone interview, urodynamic testing, and physical examination. Follow-up evaluations occur at 6 weeks, 3 months, and 1 and 2 years following surgery. Post-operative phone interviews will occur at 3 months, 6 months, and 1 and 2 years.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
322
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35233-7333
- The University of Alabama at Birmingham
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Illinois
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Maywood, Illinois, Verenigde Staten, 60153
- Loyola University Medical Center
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Iowa
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Iowa City, Iowa, Verenigde Staten, 52242
- University of Iowa College of Medicine
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21287
- Johns Hopkins School of Medicine
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27599-7590
- University of North Carolina at Chapel Hill
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213-3180
- Magee-Womens Hospital
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Texas
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Houston, Texas, Verenigde Staten, 77030
- Baylor College of Medicine
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria
- Eligibility for primary procedure (sacrocolpopexy)
- Eligibility for secondary procedure (Burch colposuspension)
- Stage II-IV anterior vaginal prolapse, defined as POP-Q Point Aa at -1, 0, +1, +2, or +3 cm.
- Negative stress incontinence screen
- Negative stress incontinence screen (MESA questionnaire)
Exclusion Criteria
Contraindication for sacrocolpopexy or Burch colposuspension.
- Anatomic contraindication for Burch colposuspension (i.e., Point Aa fixed at -2 or -3 cm).
- Surgeon judgment that a contraindication to Burch colposuspension exists.
- Anticipated geographic relocation within the first three months after surgery (e.g., within approximately 6 months of screening).
- Inability to provide informed consent or to complete testing or data collection.
- Currently pregnant.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: Abdominal Sacral Colpopexy with no Burch colposuspension
Abdominal sacral colpopexy is performed through a laparotomy approach.
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Experimenteel: Abdominal Sacral Colpopexy with Burch Colposuspension
The Burch colposuspension procedure entails the retropubic placement of at least two stitches in the vaginal tissue lateral to each side of the urethra, and suspension of these stitches from Cooper's ligament (the iliopectineal line at the superior aspect of the posterior pubic bone).
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The Burch colposuspension procedure entails the retropubic placement of at least two stitches in the vaginal tissue lateral to each side of the urethra, and suspension of these stitches from Cooper's ligament (the iliopectineal line at the superior aspect of the posterior pubic bone).
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Stress urinary continence
Tijdsspanne: 3 months
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Patients will be categorized as stress continent or stress incontinent on the basis of symptom assessment and stress testing.
The symptoms will be assessed by the stress incontinence subscale of the Pelvic Floor Distress Inventory (PFDI).
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3 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Complications at surgery
Tijdsspanne: 2 years
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Complications at surgery
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2 years
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Occurrence of other lower urinary tract symptoms
Tijdsspanne: 3 mo, 2 years
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measured by the urgency and obstructed voiding subscales of the PFDI
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3 mo, 2 years
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Other pelvic symptoms and health-related quality of life
Tijdsspanne: 3 mo, 2 years
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includes bowel function and sexual function
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3 mo, 2 years
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Linda Brubaker, MD, Loyola University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- Lukacz ES, Sridhar A, Chermansky CJ, Rahn DD, Harvie HS, Gantz MG, Varner RE, Korbly NB, Mazloomdoost D; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network (PFDN). Sexual Activity and Dyspareunia 1 Year After Surgical Repair of Pelvic Organ Prolapse. Obstet Gynecol. 2020 Sep;136(3):492-500. doi: 10.1097/AOG.0000000000003992.
- Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med. 2006 Apr 13;354(15):1557-66. doi: 10.1056/NEJMoa054208. Erratum In: N Engl J Med. 2016 Jun 9;374(23):2297-8.
- Burgio KL, Nygaard IE, Richter HE, Brubaker L, Gutman RE, Leng W, Wei J, Weber AM; Pelvic Floor Disorders Network. Bladder symptoms 1 year after abdominal sacrocolpopexy with and without Burch colposuspension in women without preoperative stress incontinence symptoms. Am J Obstet Gynecol. 2007 Dec;197(6):647.e1-6. doi: 10.1016/j.ajog.2007.08.048.
- Bradley CS, Nygaard IE, Brown MB, Gutman RE, Kenton KS, Whitehead WE, Goode PS, Wren PA, Ghetti C, Weber AM; Pelvic Floor Disorders Network. Bowel symptoms in women 1 year after sacrocolpopexy. Am J Obstet Gynecol. 2007 Dec;197(6):642.e1-8. doi: 10.1016/j.ajog.2007.08.023.
- Visco AG, Brubaker L, Nygaard I, Richter HE, Cundiff G, Fine P, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. The role of preoperative urodynamic testing in stress-continent women undergoing sacrocolpopexy: the Colpopexy and Urinary Reduction Efforts (CARE) randomized surgical trial. Int Urogynecol J Pelvic Floor Dysfunct. 2008 May;19(5):607-14. doi: 10.1007/s00192-007-0498-2. Epub 2008 Jan 9.
- Nygaard I, Handa VL, Brubaker L, Borello-France D, Wei J, Wells E, Goode P; Pelvic Floor Disorders Network. Changes in physical activity after abdominal sacrocolpopexy for advanced pelvic organ prolapse. Am J Obstet Gynecol. 2008 May;198(5):570.e1-5. doi: 10.1016/j.ajog.2008.01.044.
- Wren PA, Janz NK, FitzGerald MP, Barber MD, Burgio KL, Cundiff GW, Nygaard IE, Zyczynski HM, Gao X; Pelvic Floor Disorders Network. Optimism in women undergoing abdominal sacrocolpopexy for pelvic organ prolapse. J Am Coll Surg. 2008 Aug;207(2):240-5. doi: 10.1016/j.jamcollsurg.2008.02.019. Epub 2008 May 12.
- Goode PS, Fitzgerald MP, Richter HE, Whitehead WE, Nygaard I, Wren PA, Zyczynski HM, Cundiff G, Menefee S, Senka JM, Gao X, Weber AM; Pelvic Floor Disorders Network. Enhancing participation of older women in surgical trials. J Am Coll Surg. 2008 Sep;207(3):303-11. doi: 10.1016/j.jamcollsurg.2008.03.012. Epub 2008 May 19.
- Brubaker L, Nygaard I, Richter HE, Visco A, Weber AM, Cundiff GW, Fine P, Ghetti C, Brown MB. Two-year outcomes after sacrocolpopexy with and without burch to prevent stress urinary incontinence. Obstet Gynecol. 2008 Jul;112(1):49-55. doi: 10.1097/AOG.0b013e3181778d2a. Erratum In: Obstet Gynecol. 2016 May;127(5):968-969.
- Cundiff GW, Varner E, Visco AG, Zyczynski HM, Nager CW, Norton PA, Schaffer J, Brown MB, Brubaker L; Pelvic Floor Disorders Network. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol. 2008 Dec;199(6):688.e1-5. doi: 10.1016/j.ajog.2008.07.029. Epub 2008 Oct 31.
- Bradley CS, Kenton KS, Richter HE, Gao X, Zyczynski HM, Weber AM, Nygaard IE; Pelvic Floor Disorders Network. Obesity and outcomes after sacrocolpopexy. Am J Obstet Gynecol. 2008 Dec;199(6):690.e1-8. doi: 10.1016/j.ajog.2008.07.030. Epub 2008 Oct 9.
- Barber MD, Brubaker L, Nygaard I, Wheeler TL 2nd, Schaffer J, Chen Z, Spino C; Pelvic Floor Disorders Network. Defining success after surgery for pelvic organ prolapse. Obstet Gynecol. 2009 Sep;114(3):600-609. doi: 10.1097/AOG.0b013e3181b2b1ae.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2002
Primaire voltooiing (Werkelijk)
1 maart 2007
Studie voltooiing (Werkelijk)
1 april 2007
Studieregistratiedata
Eerst ingediend
1 augustus 2003
Eerst ingediend dat voldeed aan de QC-criteria
4 augustus 2003
Eerst geplaatst (Schatting)
5 augustus 2003
Updates van studierecords
Laatste update geplaatst (Schatting)
11 januari 2011
Laatste update ingediend die voldeed aan QC-criteria
9 januari 2011
Laatst geverifieerd
1 oktober 2010
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Gedragssymptomen
- Psychische aandoening
- Urologische ziekten
- Lagere urinewegsymptomen
- Urologische manifestaties
- Baarmoeder Ziekten
- Plasstoornissen
- Pathologische aandoeningen, anatomisch
- Eliminatiestoornissen
- Verzakking van het bekkenorgaan
- Urine-incontinentie
- Verzakking
- Bedplassen
- Urine-incontinentie, stress
- Baarmoederverzakking
Andere studie-ID-nummers
- U01HD041249 (Subsidie/contract van de Amerikaanse NIH)
- U10HD041268 (Subsidie/contract van de Amerikaanse NIH)
- U10HD041248 (Subsidie/contract van de Amerikaanse NIH)
- U10HD041250 (Subsidie/contract van de Amerikaanse NIH)
- U10HD041261 (Subsidie/contract van de Amerikaanse NIH)
- U10HD041263 (Subsidie/contract van de Amerikaanse NIH)
- U10HD041267 (Subsidie/contract van de Amerikaanse NIH)
- U10HD041269 (Subsidie/contract van de Amerikaanse NIH)
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