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

NICHD Pelvic Floor Disorders Network

Status: Completed

Conditions: Pelvic Organ Prolapse (POP)

Treatments: Procedure: SSLF; Procedure: ULS; Behavioral: PMT

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00597935

1U10HD054136 (U.S. NIH Grant/Contract)

2U10HD041267 (U.S. NIH Grant/Contract)

1U10HD054215 (U.S. NIH Grant/Contract)

2U10HD041261 (U.S. NIH Grant/Contract)

16P01

2U10HD041250 (U.S. NIH Grant/Contract)

2U01HD041249 (U.S. NIH Grant/Contract)

1U10HD054241 (U.S. NIH Grant/Contract)

1U10HD054214 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 374 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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]

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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374 participants in 4 patient groups

SSLF and PMT

Experimental group

Description:

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

Treatment:

Procedure: SSLF

Behavioral: PMT

ULS and PMT

Experimental group

Description:

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

Treatment:

Procedure: ULS

Behavioral: PMT

SSLF without PMT

Experimental group

Description:

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

Treatment:

Procedure: SSLF

ULS without PMT

Experimental group

Description:

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

Treatment:

Procedure: ULS