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Pelvic Organ Prolapse (POP)OPTIMALNCT00597935

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

A study testing SSLF, ULS and PMT in people with Pelvic Organ Prolapse (POP), run by NICHD Pelvic Floor Disorders Network at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pelvic Organ Prolapse (POP)
What is being tested?
SSLF, ULS and PMT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
374 participants
Where
9 sitesUnited States
Study dates
Feb 2008to Jul 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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]

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Kaiser Permanente Bellflower

    Bellflower, California, 90706

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35233-7333

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • Duke University

    Durham, North Carolina, 27710

  • University of California, San Diego Medical Center

    La Jolla, California, 92037

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Utah

    Salt Lake City, Utah, 84132

  • Kaiser Permanente

    San Diego, California, 92120

Other trials in United States

About this study

Official title: Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial: A Randomized Trial of Sacrospinous Ligament Fixation (SSLF) Versus Uterosacral Ligament Suspension (ULS) With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training

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. to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS); and
  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.
Read the detailed description

Many women develop pelvic organ prolapse over the course of their lives. Pelvic organ prolapse is the downward descent of the pelvic organs (which include the uterus, bladder and bowel) into the vagina. Researchers estimate that between 7-10% of women will require surgery for prolapse sometime in their lifetime. Many will have more than one operation for the prolapse. Because this is such a common problem, the investigators in the Pelvic Floor Disorders Network strive to offer women the best treatment options. However, there were not enough carefully designed and conducted research studies to help guide them in this direction.

Women who are planning surgery for apical vaginal prolapse often experience bladder and bowel symptoms, as well as pressure and a bulge. These symptoms might include urinary leakage (urinary incontinence), urinary urgency (a sudden strong desire to urinate with fear that leakage may occur) or frequent urination, difficulty starting to urinate or perhaps a slow weak urinary stream, as well as accidental bowel leakage (fecal incontinence). After surgery, bladder and bowel symptoms may get better, get worse, or stay the same as before surgery. Sometimes new symptoms can start after surgery even if they weren't present before surgery.

The OPTIMAL study was designed to compare two commonly performed vaginal surgeries for pelvic organ prolapse. One is the sacrospinous ligament fixation, called SSLF for short. The other is the uterosacral ligament suspension, called ULS. Both surgeries involve attaching the top of the vagina, which has fallen down, to internal ligaments in the pelvis in order to resuspend the vagina and correct the prolapse.

The investigators were also interested in studying how the surgeries altered bladder and bowel symptoms. They had seen in other studies that behavioral and pelvic floor muscle therapy (PMT) is an effective therapy for stress and urge urinary incontinence, fecal incontinence, and other pelvic floor disorders. It is relatively easy to perform, and has rare side effects. They wondered if PMT around the time of surgery might further improve these symptoms.

The OPTIMAL study has two main purposes:

  1. To find out which type of surgery, SSLF or ULS, has better results when used to repair prolapse of the top of the vagina,
  2. To find out whether or not doing pelvic muscle exercises and behavioral changes around the time of surgery will affect both bladder and bowel symptoms after surgery, and the success of the prolapse repair.

Four Hundred women were enrolled into the OPTIMAL study, from January 2008 to May 2011. These women were randomly assigned to receive either the SSLF or the ULS surgery. They were randomly assigned to either receive the PMT training with a therapist before and after surgery or to not receive this therapy. So women fell into one of four groups:

  1. SSLF plus PMT
  2. ULS plus PMT
  3. SSLF without PMT
  4. ULS without PMT

Women in this study were followed closely at regular intervals for two years after surgery.

Being tested
SSLF, ULS, PMT
Keywords
prolapse, urinary incontinence, uterosacral vaginal vault ligament suspension, sacrospinous ligament fixation, behavioral therapy, pelvic muscle training
Medical subject headings
Pelvic Organ Prolapse, Prolapse, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SSLFProcedure or surgery

    sacrospinous ligament fixation (SSLF)

  • ULSProcedure or surgery

    uterosacral vaginal vault ligament suspension (ULS)

  • PMTBehavioural

    Pelvic muscle training and exercises (PMT)

Study groups in NCT00597935
Study groupRoleWhat they receive
SSLF and PMTExperimentalSacrospinous Ligament Fixation (SSLF) and Pelvic Muscle Training \& Exercises (PMT)
Receives: Procedure: SSLF; Behavioral: PMT
ULS and PMTExperimentalUterosacral Vaginal Vault Ligament Suspension (ULS) and Pelvic Muscle Training \& Exercises (PMT)
Receives: Procedure: ULS; Behavioral: PMT
SSLF without PMTExperimentalSacrospinous Ligament Fixation (SSLF) without Pelvic Muscle Training \& Exercises (PMT)
Receives: Procedure: SSLF
ULS without PMTExperimentalUterosacral Vaginal Vault Ligament Suspension (ULS) without Pelvic Muscle Training \& Exercises (PMT)
Receives: Procedure: ULS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 months

  2. 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.

    Measured: 24 months

  3. 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.

    Measured: 6 months

Secondary outcomes (9)

  1. Change From Baseline: Urinary Distress Inventory

    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). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.

    Measured: Baseline and 24 months

  2. Change From Baseline: Pelvic Organ Prolapse Distress Inventory

    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 POPDI is: 0-300 with 0 (least distress) to 300 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.

    Measured: Baseline and 24 months

  3. Change From Baseline: Colorectal Anal Distress Inventory

    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 CRADI is: 0-400 with 0 (least distress) to 400 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.

    Measured: Baseline and 24 months

  4. Urinary Impact Questionnaire Change From Baseline to 24 Months

    The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.

    Measured: Baseline and 24 months

  5. Pelvic Organ Prolapse Impact Questionnaire Change From Baseline to 24 Months

    The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year 2 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.

    Measured: Baseline and 24 months

  6. Colorectal-Anal Impact Questionnaire Change From Baseline to 24 Months

    The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year 2 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.

    Measured: Baseline and 24 months

  7. Sexual Function 36 - Physical Health Component Score Change From Baseline to 24 Months

    Sexual Function 36 (SF36) - Physical Health Component Score is the physical health component of the Sexual Function 36 survey with scores ranging from 0 to 100 with higher scores meaning a better health state. Scales are scored according to the algorithm that describes the handling of the various types of questions included in the questionnaire. Several steps are involved in the scoring process: recoding items that require it; summing over items; and transforming raw scale scores to a 0 to 100 scale. This physical health component is a function of several constructs measured under the SF36: physical functioning, physical role, bodily pain, general health, and vitality.

    Measured: Baseline and 24 months

  8. Sexual Function 36 - Mental Health Component Score Change From Baseline to 24 Months

    Sexual Function 36 (SF36) - Mental Health Component Score is the mental health component of the Sexual Function 36 survey with scores ranging from 0 to 100 with higher scores meaning a better health state. Scales are scored according to the algorithm that describes the handling of the various types of questions included in the questionnaire. Several steps are involved in the scoring process: recoding items that require it; summing over items; and transforming raw scale scores to a 0 to 100 scale.

    Measured: Baseline and 24 months

  9. Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Change From Baseline to 24 Months

    Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) is a survey of sexual functioning with scores ranging from 0 to 48 with higher scores meaning better sexual functioning. Patients were asked to answer 31 questions about their sexuality in the past 6 months.

    Measured: Baseline and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionJul 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00597935
Sponsor's protocol ID
16P01
Other IDs
2U01HD041249, 2U10HD041250, 2U10HD041261, 2U10HD041267, 1U10HD054136, 1U10HD054214, 1U10HD054215, 1U10HD054241
Acronym
OPTIMAL
Status last verified
Oct 2020
First submitted
9 Jan 2008
Last updated
22 Oct 2020
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 19130903

  • 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.

    PubMed 37318279

  • 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.

    PubMed 33030871

  • 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.

    PubMed 32769645

  • 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.

    PubMed 31449806

  • 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.

    PubMed 27159758

  • 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.

    PubMed 24618964

  • 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.

    PubMed 22777368

  • 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.

    PubMed 22777367

Questions about this trial

What is this clinical trial studying?

A study testing SSLF, ULS and PMT in people with Pelvic Organ Prolapse (POP), run by NICHD Pelvic Floor Disorders Network at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical Success (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00597935, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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