Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial

NCT00597935 | Completed Results DMC

• 9 other identifiers: 16P012U01HD0412492U10HD0412502U10HD0412612U10HD0412671U10HD0541361U10HD0542141U10HD0542151U10HD054241
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 9

Brief Summary

Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Pelvic organ prolapse often involves a combination of support defects involving the anterior, posterior and/or apical vaginal segments. While the anterior vaginal wall is the segment most likely to demonstrate recurrent prolapse after reconstructive surgery, reoperations are highest among those who require apical suspension procedures with or without repair of other vaginal segments (12%-33%). Despite the substantial health impact, there is a paucity of high quality evidence to support different practices in the management of prolapse, particularly surgery. Thus, the objectives of the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) Trial are:

1. 1.to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS); and
2. 2.to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence.

Conditions

Pelvic Organ Prolapse (POP)

Keywords

prolapse; urinary incontinence; uterosacral vaginal vault ligament suspension; sacrospinous ligament fixation; behavioral therapy; pelvic muscle training

Outcome Measures

Primary Outcomes (3)

• Surgical Success

  The absence of the following: (1) descent of the vaginal apex more than one-third into the vaginal canal; (2) anterior or posterior vaginal wall descent beyond the hymen; (3) bothersome vaginal bulge symptoms as indicated by an affirmative response to either 'Do you usually have a sensation of bulging or protrusion from the vaginal area?' or 'Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?' in the Pelvic Floor Distress Inventory and any response other than 'not at all' to the question 'How much does this bother you?'; or (4) re-treatment for prolapse by either surgery or pessary.

  24 months

• Anatomic Failure

  Anatomic failure is defined by one of the following: descent of the vaginal apex more than one-third into the vaginal canal, anterior or posterior vaginal wall descent beyond the hymen, or re-treatment for prolapse.

  24 months

• Urinary Distress Inventory at 6 Months

  The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the UDI is: 0-300 with 0 (least distress) to 300 (most distress). Lower scores indicate better function / fewer symptoms.

  6 months

Secondary Outcomes (9)

• Change From Baseline: Urinary Distress Inventory

  Baseline and 24 months

• Change From Baseline: Pelvic Organ Prolapse Distress Inventory

  Baseline and 24 months

• Change From Baseline: Colorectal Anal Distress Inventory

  Baseline and 24 months

• Urinary Impact Questionnaire Change From Baseline to 24 Months

  Baseline and 24 months

• Pelvic Organ Prolapse Impact Questionnaire Change From Baseline to 24 Months

  Baseline and 24 months

Study Arms (4)

SSLF and PMT

EXPERIMENTAL

Sacrospinous Ligament Fixation (SSLF) and Pelvic Muscle Training \& Exercises (PMT)

Procedure: SSLF; Behavioral: PMT

ULS and PMT

EXPERIMENTAL

Uterosacral Vaginal Vault Ligament Suspension (ULS) and Pelvic Muscle Training \& Exercises (PMT)

Procedure: ULS; Behavioral: PMT

SSLF without PMT

EXPERIMENTAL

Sacrospinous Ligament Fixation (SSLF) without Pelvic Muscle Training \& Exercises (PMT)

Procedure: SSLF

ULS without PMT

EXPERIMENTAL

Uterosacral Vaginal Vault Ligament Suspension (ULS) without Pelvic Muscle Training \& Exercises (PMT)

Procedure: ULS

Interventions

SSLF PROCEDURE

sacrospinous ligament fixation (SSLF)

SSLF and PMT; SSLF without PMT

ULS PROCEDURE

uterosacral vaginal vault ligament suspension (ULS)

ULS and PMT; ULS without PMT

PMT BEHAVIORAL

Pelvic muscle training and exercises (PMT)

SSLF and PMT; ULS and PMT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage 2 to 4 prolapse
• Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal (POPQ Point C \> -TVL/2) \[TVL stands for total vaginal length\]
• Vaginal bulge symptoms as indicated by an affirmative response to either questions on the Pelvic Floor Distress Inventory (PFDI)
• Vaginal surgery for prolapse is planned, including a vaginal apical suspension procedure.
• Stress incontinence symptoms as indicated by an affirmative response to the PFDI Stress incontinence subscale
• Documentation of transurethral stress leakage on an office stress test or urodynamics with or without prolapse reduction within the previous 12 months
• A tension free vaginal tape (TVT) is planned to treat stress urinary incontinence.
• A pelvic muscle training (PMT) visit can be performed at least 2 weeks and not more than 4 weeks before surgery.
• Available for 24-months of follow-up.
• Able to complete study assessments, per clinician judgment
• Able and willing to provide written informed consent

You may not qualify if:

• Contraindication to sacrospinous ligament fixation (SSLF), uterosacral vaginal vault ligament suspension (ULS), or TVT in the opinion of the treating surgeon.
• History of previous surgery that included a SSLF or ULS. (Previous vaginal vault suspensions using other techniques or in which the previous technique is unknown are eligible.)
• Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT program.
• History of previous synthetic sling procedure for stress incontinence.
• Previous adverse reaction to synthetic mesh.
• Urethral diverticulum, current or previous (i.e., repaired)
• History of femoral to femoral bypass.
• Current cytotoxic chemotherapy or current or history of pelvic radiation therapy.
• History of two inpatient hospitalizations for medical comorbidities in the previous 12 months.
• Subject wishes to retain her uterus. \[Both ULS and SLS include removal of the uterus, if not previously removed\]

Sponsors & Collaborators

• NICHD Pelvic Floor Disorders Network: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (9)

The University of Alabama at Birmingham

Birmingham, Alabama, 35233-7333, United States

Location

Kaiser Permanente Bellflower

Bellflower, California, 90706, United States

Location

University of California, San Diego Medical Center

La Jolla, California, 92037, United States

Location

Kaiser Permanente

San Diego, California, 92120, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (9)

• Barber MD, Brubaker L, Menefee S, Norton P, Borello-France D, Varner E, Schaffer J, Weidner A, Xu X, Spino C, Weber A; Pelvic Floor Disorders Network. Operations and pelvic muscle training in the management of apical support loss (OPTIMAL) trial: design and methods. Contemp Clin Trials. 2009 Mar;30(2):178-89. doi: 10.1016/j.cct.2008.12.001. Epub 2008 Dec 16.

  PMID: 19130903 BACKGROUND

• Borello-France D, Newman DK, Markland AD, Propst K, Jelovsek JE, Cichowski S, Gantz MG, Balgobin S, Jakus-Waldman S, Korbly N, Mazloomdoost D, Burgio KL; NICHD Pelvic Floor Disorders Network. Adherence to Perioperative Behavioral Therapy With Pelvic Floor Muscle Training in Women Receiving Vaginal Reconstructive Surgery for Pelvic Organ Prolapse. Phys Ther. 2023 Sep 1;103(9):pzad059. doi: 10.1093/ptj/pzad059.

  PMID: 37318279 DERIVED

• Jakus-Waldman S, Brubaker L, Jelovsek JE, Schaffer JI, Ellington DR, Mazloomdoost D, Whitworth R, Gantz MG; NICHD Pelvic Floor Disorders Network (PFDN). Risk Factors for Surgical Failure and Worsening Pelvic Floor Symptoms Within 5 Years After Vaginal Prolapse Repair. Obstet Gynecol. 2020 Nov;136(5):933-941. doi: 10.1097/AOG.0000000000004092.

  PMID: 33030871 DERIVED

• 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.

  PMID: 32769645 DERIVED

• Sutkin G, Zyczynski HM, Sridhar A, Jelovsek JE, Rardin CR, Mazloomdoost D, Rahn DD, Nguyen JN, Andy UU, Meyer I, Gantz MG; NICHD Pelvic Floor Disorders Network. Association between adjuvant posterior repair and success of native tissue apical suspension. Am J Obstet Gynecol. 2020 Feb;222(2):161.e1-161.e8. doi: 10.1016/j.ajog.2019.08.024. Epub 2019 Aug 23.

  PMID: 31449806 DERIVED

• Lukacz ES, Warren LK, Richter HE, Brubaker L, Barber MD, Norton P, Weidner AC, Nguyen JN, Gantz MG. Quality of Life and Sexual Function 2 Years After Vaginal Surgery for Prolapse. Obstet Gynecol. 2016 Jun;127(6):1071-1079. doi: 10.1097/AOG.0000000000001442.

  PMID: 27159758 DERIVED

• Barber MD, Brubaker L, Burgio KL, Richter HE, Nygaard I, Weidner AC, Menefee SA, Lukacz ES, Norton P, Schaffer J, Nguyen JN, Borello-France D, Goode PS, Jakus-Waldman S, Spino C, Warren LK, Gantz MG, Meikle SF; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. JAMA. 2014 Mar 12;311(10):1023-34. doi: 10.1001/jama.2014.1719.

  PMID: 24618964 DERIVED

• Barber MD, Kenton K, Janz NK, Hsu Y, Dyer KY, Greer WJ, White A, Meikle S, Ye W. Validation of the activities assessment scale in women undergoing pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):205-10. doi: 10.1097/SPV.0b013e31825e6422.

  PMID: 22777368 DERIVED

• Barber MD, Janz N, Kenton K, Hsu Y, Greer WJ, Dyer K, White A, Meikle S, Ye W. Validation of the surgical pain scales in women undergoing pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):198-204. doi: 10.1097/SPV.0b013e31825d65aa.

  PMID: 22777367 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse; Prolapse; Urinary Incontinence

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Marie Gantz
• Organization: RTI International

mgantz@rti.org

919-597-5110

Study Officials

• Matthew Barber, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 18, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 22, 2020
• Results First Posted: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)