Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial - Design and methods

John Wei; Ingrid Nygaard; Holly Richter; Morton Brown; Matthew Barber; Xiao Xu; Kimberly Kenton; Charles Nager; Joseph Schaffer; Anthony Visco; Anne Weber; Mathew D. Barber; Marie Fidela Paraisor; Mark D. Walters; J. Eric Jelovsek; Firouz Daneshgari; Linda McElrath; Donel Murphy; Cheryl Williams; Anthony G. Visco; Jennifer Wu; Alison Weider; Cindy Amundsen; Mary J. Loomis; Linda Brubaker; Kimberly Kenton; MaryPat P. FitzGerald; Elizabeth Mueller; Kathy Marchese; Mary Tulke; Holly E. Richter; R. Edward Varner; Robert L. Holley; Thomas L. Wheeler; Patricia S. Goode; L. Keith Lloyd; Alayne D. Markland; Velria Willis; Nancy Saxon; LaChele Ward; Lisa S. Pair; Charles W. Nager; Shawn A. Menefee; Emily Lukacz; Karl M. Luber; Michael E. Albo; Margie Kahn; Lysa Woodall; Giselle Zazueta-Damian; Morton B. Brown; Cathie Spino; John T. Wei; Beverly Marchant; Donna DiFranco; John O L DeLancey; Dee Fenner; Nancy K. Janz; Wen Ye; Zhen Chen; Yang Wang Casher; Joseph Schaffer; Clifford Wai; Marlene Corton; Gary Lemack; Kelly Moore; David Rahn; Amanda White; Shanna Atnip; M. Hull Margaret; Pam Martinez; Deborah Lawson; Ingrid Nygaard; Peggy Norton; Linda Freeman; Anne M. Weber; Susan Meikle

doi:10.1177/1740774509102605

Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial - Design and methods

John Wei, Ingrid Nygaard, Holly Richter, Morton Brown, Matthew Barber, Xiao Xu, Kimberly Kenton, Charles Nager, Joseph Schaffer, Anthony Visco, Anne Weber, Mathew D. Barber, Marie Fidela Paraisor, Mark D. Walters, J. Eric Jelovsek, Firouz Daneshgari, Linda McElrath, Donel Murphy, Cheryl Williams, Anthony G. ViscoJennifer Wu, Alison Weider, Cindy Amundsen, Mary J. Loomis, Linda Brubaker, Kimberly Kenton, MaryPat P. FitzGerald, Elizabeth Mueller, Kathy Marchese, Mary Tulke, Holly E. Richter, R. Edward Varner, Robert L. Holley, Thomas L. Wheeler, Patricia S. Goode, L. Keith Lloyd, Alayne D. Markland, Velria Willis, Nancy Saxon, LaChele Ward, Lisa S. Pair, Charles W. Nager, Shawn A. Menefee, Emily Lukacz, Karl M. Luber, Michael E. Albo, Margie Kahn, Lysa Woodall, Giselle Zazueta-Damian, Morton B. Brown, Cathie Spino, John T. Wei, Beverly Marchant, Donna DiFranco, John O L DeLancey, Dee Fenner, Nancy K. Janz, Wen Ye, Zhen Chen, Yang Wang Casher, Joseph Schaffer, Clifford Wai, Marlene Corton, Gary Lemack, Kelly Moore, David Rahn, Amanda White, Shanna Atnip, M. Hull Margaret, Pam Martinez, Deborah Lawson, Ingrid Nygaard, Peggy Norton, Linda Freeman, Anne M. Weber, Susan Meikle

Research output: Contribution to journal › Article › peer-review

39 Scopus citations

Abstract

Background: The primary aims of this trial are to determine whether the use of a concomitant prophylactic anti-incontinence procedure may prevent stress urinary incontinence symptom development in women undergoing vaginal prolapse surgery and to evaluate the cost-effectiveness of this prophylactic approach. Purpose: To present the rationale and design of a randomized controlled surgical trial (RCT), the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) Trial highlighting the challenges in the design and implementation. Methods: The challenges of implementing this surgical trial combined with a cost-effectiveness study and patient preference group are discussed including the study design, ethical issues regarding use of sham incision, maintaining the masking of study staff, and pragmatic difficulties encountered in the collection of cost data. The trial is conducted by the NICHD-funded Pelvic Floor Disorders Network. Results: The ongoing OPUS trial started enrollment in May 2007 with a planned accrual of 350. The use of sham incision was generally well accepted but the collection of cost data using conventional billing forms was found to potentially unmask key study personnel. This necessitated changes in the study forms and planned timing for collection of cost data. To date, the enrollment to the patient preference group has been lower than the limit established by the protocol suggesting a willingness on the part of women to participate in the randomization. Limitations: Given the invasive nature of surgical intervention trials, potential participants may be reluctant to accept random assignment, potentially impacting generalizability. Conclusion: Findings from the OPUS trial will provide important information that will help surgeons to better counsel women on the benefits and risks of concomitant prophylactic anti-incontinence procedure at the time of vaginal surgery for prolapse. The implementation of the OPUS trial has necessitated that investigators consider ethical issues up front, remain flexible with regards to data collection and be constantly aware of unanticipated opportunities for unmasking. Future surgical trials should be aware of potential challenges in maintaining masking and collection of cost-related information.

Original language	English (US)
Pages (from-to)	162-171
Number of pages	10
Journal	Clinical Trials
Volume	6
Issue number	2
DOIs	https://doi.org/10.1177/1740774509102605
State	Published - 2009

ASJC Scopus subject areas

Pharmacology

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Wei, J., Nygaard, I., Richter, H., Brown, M., Barber, M., Xu, X., Kenton, K., Nager, C., Schaffer, J., Visco, A., Weber, A., Barber, M. D., Paraisor, M. F., Walters, M. D., Jelovsek, J. E., Daneshgari, F., McElrath, L., Murphy, D., Williams, C., ... Meikle, S. (2009). Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial - Design and methods. Clinical Trials, 6(2), 162-171. https://doi.org/10.1177/1740774509102605

Wei, J, Nygaard, I, Richter, H, Brown, M, Barber, M, Xu, X, Kenton, K, Nager, C, Schaffer, J, Visco, A, Weber, A, Barber, MD, Paraisor, MF, Walters, MD, Jelovsek, JE, Daneshgari, F, McElrath, L, Murphy, D, Williams, C, Visco, AG, Wu, J, Weider, A, Amundsen, C, Loomis, MJ, Brubaker, L, Kenton, K, FitzGerald, MP, Mueller, E, Marchese, K, Tulke, M, Richter, HE, Varner, RE, Holley, RL, Wheeler, TL, Goode, PS, Lloyd, LK, Markland, AD, Willis, V, Saxon, N, Ward, L, Pair, LS, Nager, CW, Menefee, SA, Lukacz, E, Luber, KM, Albo, ME, Kahn, M, Woodall, L, Zazueta-Damian, G, Brown, MB, Spino, C, Wei, JT, Marchant, B, DiFranco, D, DeLancey, JOL, Fenner, D, Janz, NK, Ye, W, Chen, Z, Casher, YW, Schaffer, J, Wai, C , Corton, M , Lemack, G, Moore, K, Rahn, D, White, A, Atnip, S, Hull Margaret, M, Martinez, P, Lawson, D, Nygaard, I, Norton, P, Freeman, L, Weber, AM & Meikle, S 2009, 'Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial - Design and methods', Clinical Trials, vol. 6, no. 2, pp. 162-171. https://doi.org/10.1177/1740774509102605

@article{874b0997b67c46648c405c9bd5d8ea54,

title = "Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial - Design and methods",

abstract = "Background: The primary aims of this trial are to determine whether the use of a concomitant prophylactic anti-incontinence procedure may prevent stress urinary incontinence symptom development in women undergoing vaginal prolapse surgery and to evaluate the cost-effectiveness of this prophylactic approach. Purpose: To present the rationale and design of a randomized controlled surgical trial (RCT), the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) Trial highlighting the challenges in the design and implementation. Methods: The challenges of implementing this surgical trial combined with a cost-effectiveness study and patient preference group are discussed including the study design, ethical issues regarding use of sham incision, maintaining the masking of study staff, and pragmatic difficulties encountered in the collection of cost data. The trial is conducted by the NICHD-funded Pelvic Floor Disorders Network. Results: The ongoing OPUS trial started enrollment in May 2007 with a planned accrual of 350. The use of sham incision was generally well accepted but the collection of cost data using conventional billing forms was found to potentially unmask key study personnel. This necessitated changes in the study forms and planned timing for collection of cost data. To date, the enrollment to the patient preference group has been lower than the limit established by the protocol suggesting a willingness on the part of women to participate in the randomization. Limitations: Given the invasive nature of surgical intervention trials, potential participants may be reluctant to accept random assignment, potentially impacting generalizability. Conclusion: Findings from the OPUS trial will provide important information that will help surgeons to better counsel women on the benefits and risks of concomitant prophylactic anti-incontinence procedure at the time of vaginal surgery for prolapse. The implementation of the OPUS trial has necessitated that investigators consider ethical issues up front, remain flexible with regards to data collection and be constantly aware of unanticipated opportunities for unmasking. Future surgical trials should be aware of potential challenges in maintaining masking and collection of cost-related information.",

author = "John Wei and Ingrid Nygaard and Holly Richter and Morton Brown and Matthew Barber and Xiao Xu and Kimberly Kenton and Charles Nager and Joseph Schaffer and Anthony Visco and Anne Weber and Barber, {Mathew D.} and Paraisor, {Marie Fidela} and Walters, {Mark D.} and Jelovsek, {J. Eric} and Firouz Daneshgari and Linda McElrath and Donel Murphy and Cheryl Williams and Visco, {Anthony G.} and Jennifer Wu and Alison Weider and Cindy Amundsen and Loomis, {Mary J.} and Linda Brubaker and Kimberly Kenton and FitzGerald, {MaryPat P.} and Elizabeth Mueller and Kathy Marchese and Mary Tulke and Richter, {Holly E.} and Varner, {R. Edward} and Holley, {Robert L.} and Wheeler, {Thomas L.} and Goode, {Patricia S.} and Lloyd, {L. Keith} and Markland, {Alayne D.} and Velria Willis and Nancy Saxon and LaChele Ward and Pair, {Lisa S.} and Nager, {Charles W.} and Menefee, {Shawn A.} and Emily Lukacz and Luber, {Karl M.} and Albo, {Michael E.} and Margie Kahn and Lysa Woodall and Giselle Zazueta-Damian and Brown, {Morton B.} and Cathie Spino and Wei, {John T.} and Beverly Marchant and Donna DiFranco and DeLancey, {John O L} and Dee Fenner and Janz, {Nancy K.} and Wen Ye and Zhen Chen and Casher, {Yang Wang} and Joseph Schaffer and Clifford Wai and Marlene Corton and Gary Lemack and Kelly Moore and David Rahn and Amanda White and Shanna Atnip and {Hull Margaret}, M. and Pam Martinez and Deborah Lawson and Ingrid Nygaard and Peggy Norton and Linda Freeman and Weber, {Anne M.} and Susan Meikle",

year = "2009",

doi = "10.1177/1740774509102605",

language = "English (US)",

volume = "6",

pages = "162--171",

journal = "Clinical Trials",

issn = "1740-7745",

publisher = "SAGE Publications Ltd",

number = "2",

}

TY - JOUR

T1 - Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial - Design and methods

AU - Wei, John

AU - Nygaard, Ingrid

AU - Richter, Holly

AU - Brown, Morton

AU - Barber, Matthew

AU - Xu, Xiao

AU - Kenton, Kimberly

AU - Nager, Charles

AU - Schaffer, Joseph

AU - Visco, Anthony

AU - Weber, Anne

AU - Barber, Mathew D.

AU - Paraisor, Marie Fidela

AU - Walters, Mark D.

AU - Jelovsek, J. Eric

AU - Daneshgari, Firouz

AU - McElrath, Linda

AU - Murphy, Donel

AU - Williams, Cheryl

AU - Visco, Anthony G.

AU - Wu, Jennifer

AU - Weider, Alison

AU - Amundsen, Cindy

AU - Loomis, Mary J.

AU - Brubaker, Linda

AU - Kenton, Kimberly

AU - FitzGerald, MaryPat P.

AU - Mueller, Elizabeth

AU - Marchese, Kathy

AU - Tulke, Mary

AU - Richter, Holly E.

AU - Varner, R. Edward

AU - Holley, Robert L.

AU - Wheeler, Thomas L.

AU - Goode, Patricia S.

AU - Lloyd, L. Keith

AU - Markland, Alayne D.

AU - Willis, Velria

AU - Saxon, Nancy

AU - Ward, LaChele

AU - Pair, Lisa S.

AU - Nager, Charles W.

AU - Menefee, Shawn A.

AU - Lukacz, Emily

AU - Luber, Karl M.

AU - Albo, Michael E.

AU - Kahn, Margie

AU - Woodall, Lysa

AU - Zazueta-Damian, Giselle

AU - Brown, Morton B.

AU - Spino, Cathie

AU - Wei, John T.

AU - Marchant, Beverly

AU - DiFranco, Donna

AU - DeLancey, John O L

AU - Fenner, Dee

AU - Janz, Nancy K.

AU - Ye, Wen

AU - Chen, Zhen

AU - Casher, Yang Wang

AU - Schaffer, Joseph

AU - Wai, Clifford

AU - Corton, Marlene

AU - Lemack, Gary

AU - Moore, Kelly

AU - Rahn, David

AU - White, Amanda

AU - Atnip, Shanna

AU - Hull Margaret, M.

AU - Martinez, Pam

AU - Lawson, Deborah

AU - Nygaard, Ingrid

AU - Norton, Peggy

AU - Freeman, Linda

AU - Weber, Anne M.

AU - Meikle, Susan

PY - 2009

Y1 - 2009

N2 - Background: The primary aims of this trial are to determine whether the use of a concomitant prophylactic anti-incontinence procedure may prevent stress urinary incontinence symptom development in women undergoing vaginal prolapse surgery and to evaluate the cost-effectiveness of this prophylactic approach. Purpose: To present the rationale and design of a randomized controlled surgical trial (RCT), the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) Trial highlighting the challenges in the design and implementation. Methods: The challenges of implementing this surgical trial combined with a cost-effectiveness study and patient preference group are discussed including the study design, ethical issues regarding use of sham incision, maintaining the masking of study staff, and pragmatic difficulties encountered in the collection of cost data. The trial is conducted by the NICHD-funded Pelvic Floor Disorders Network. Results: The ongoing OPUS trial started enrollment in May 2007 with a planned accrual of 350. The use of sham incision was generally well accepted but the collection of cost data using conventional billing forms was found to potentially unmask key study personnel. This necessitated changes in the study forms and planned timing for collection of cost data. To date, the enrollment to the patient preference group has been lower than the limit established by the protocol suggesting a willingness on the part of women to participate in the randomization. Limitations: Given the invasive nature of surgical intervention trials, potential participants may be reluctant to accept random assignment, potentially impacting generalizability. Conclusion: Findings from the OPUS trial will provide important information that will help surgeons to better counsel women on the benefits and risks of concomitant prophylactic anti-incontinence procedure at the time of vaginal surgery for prolapse. The implementation of the OPUS trial has necessitated that investigators consider ethical issues up front, remain flexible with regards to data collection and be constantly aware of unanticipated opportunities for unmasking. Future surgical trials should be aware of potential challenges in maintaining masking and collection of cost-related information.

AB - Background: The primary aims of this trial are to determine whether the use of a concomitant prophylactic anti-incontinence procedure may prevent stress urinary incontinence symptom development in women undergoing vaginal prolapse surgery and to evaluate the cost-effectiveness of this prophylactic approach. Purpose: To present the rationale and design of a randomized controlled surgical trial (RCT), the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) Trial highlighting the challenges in the design and implementation. Methods: The challenges of implementing this surgical trial combined with a cost-effectiveness study and patient preference group are discussed including the study design, ethical issues regarding use of sham incision, maintaining the masking of study staff, and pragmatic difficulties encountered in the collection of cost data. The trial is conducted by the NICHD-funded Pelvic Floor Disorders Network. Results: The ongoing OPUS trial started enrollment in May 2007 with a planned accrual of 350. The use of sham incision was generally well accepted but the collection of cost data using conventional billing forms was found to potentially unmask key study personnel. This necessitated changes in the study forms and planned timing for collection of cost data. To date, the enrollment to the patient preference group has been lower than the limit established by the protocol suggesting a willingness on the part of women to participate in the randomization. Limitations: Given the invasive nature of surgical intervention trials, potential participants may be reluctant to accept random assignment, potentially impacting generalizability. Conclusion: Findings from the OPUS trial will provide important information that will help surgeons to better counsel women on the benefits and risks of concomitant prophylactic anti-incontinence procedure at the time of vaginal surgery for prolapse. The implementation of the OPUS trial has necessitated that investigators consider ethical issues up front, remain flexible with regards to data collection and be constantly aware of unanticipated opportunities for unmasking. Future surgical trials should be aware of potential challenges in maintaining masking and collection of cost-related information.

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Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial - Design and methods

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