OPTIMAL

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 (BPMT) 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 BPMT 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 BPMT 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 BPMT
2. ULS plus BPMT
3. SSLF without BPMT
4. ULS without BPMT

Women in this study are being followed closely at regular intervals for two years after surgery. The investigators will publish their findings about bladder and bowel symptoms in all groups of women after 6 months. They intend to report the results of anatomic support of the pelvic organs 2 years after the last women had surgery. We will summarize the findings of the study here as soon as they become available.

To learn about longer effects of the treatments, the women in the Optimal Study are being invited to participate in the Extended OPTIMAL study.

Click for more information about the extended follow-up study (E-Optimal).

ClinicalTrials.gov

Read more about this study at clinicaltrials.gov.