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

Overview

Status: Active, not recruiting
Keywords: Pelvic Organ Prolapse , Urogenital Prolapse , Vaginal Prolapse
IRB Number: 00027613
Specialty: Urogyn and Pelvic Reconstructive Surgery
Sub Specialties:

Brief Summary

Of the different types of vaginal surgery to repair pelvic organ prolapse (the downward descent of the pelvic organs that results in a protrusion of the vagina, uterus, or both) there is not enough information about which surgery provides the best symptom relief while causing the fewest problems (complications) after surgery. The study population will consist of women with Stage 2-4 prolapse and stress urinary incontinence symptoms who have prolapse at the vaginal apex or uterus and are scheduled for prolapse surgery via a vaginal approach. Prolapse often involves a combination of support defects; of all these repairs the apical suspension procedures have the highest reoperations for surgical failure. Two of the most common vaginal surgeries used to repair apical prolapse are the sacrospinous ligament fixation, called SSLF for short, and 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. One aim of the study is to find out which type of surgery, SSLF or ULS, has better results when used to repair prolapse of the top of the vagina (apical prolapse).
 

 
Many women who are planning surgery for apical vaginal prolapse also have bladder and bowel symptoms, as well as bulge symptoms. Study eligible patients will have stress urinary incontinence which will be treated surgically with a Tension-Free Vaginal Tape (TVT®) in addition to prolapse repair. Combining prolapse surgery with pelvic muscle exercises and behavioral changes may relieve symptoms that were present before surgery or prevent new symptoms from developing after surgery. Whether PMT is effective in reducing the recurrence of prolapse or its symptoms in the long-term is unknown. Timing the practice of pelvic muscle training shortly before and after surgery for prolapse and urinary incontinence may enhance the outcome of the training and possibly help the results of the prolapse surgery to last longer. The assessment of the short- and long-term effects and the cost-effectiveness of perioperative PMT on the full range of pelvic floor disorders symptoms as well as sexual, QOL and anatomic outcomes of women undergoing vaginal surgery for advanced prolapse, will provide substantial insight into the potential merits of this adjunctive treatment. .
 

 
Study surgeons and coordinators will screen eligible individuals. Study eligible patients will be approached to consent for the study. The consented patients’ medical, surgical and obstetrical histories will be collected by interview and medical record review to establish baseline data pre-operatively. Research staff will perform a pelvic examination and assess the stage of prolapse. All physical examinations will be performed by appropriately trained research staff at the clinical site. Subjects who are randomized to perioperative PMT will receive a formal individualized PMT program that begins two to four weeks prior to surgery and continues for three months after surgery.
 

 
Randomization to the PMT Intervention (PMT vs. usual care) is done preoperatively. Participants will be randomized in the operating room to the surgical intervention (SSLF or ULS). Subjects will receive the allocated vaginal vault suspension along with other vaginal prolapse surgery as indicated and surgical treatment for stress incontinence. The primary outcome measure for the surgical intervention will be surgical “success” or “failure” as a dichotomous outcome at 2 years after surgery. The primary outcome measure has 2 components:
 
(1) an anatomic assessment of prolapse, using the Pelvic Organ Prolapse Quantification (POPQ) system, and
 
(2) the presence or absence of bulge symptoms specific to prolapse.
 
The intent is to assess the superiority of each of the two interventions.
 

 
Participation in the study may last for 2 years. The study will include seven to eight clinic visits; a maximum of four study nurse telephone calls and four quality of life telephone interviews over the 24 months of the study. Participants randomized to the perioperative PMT treatment will have an additional visit preoperatively and at 8 weeks post-operatively.
 

Principal Investigator: Ingrid Nygaard
Department: Urogynecology
Co Investigator: Yvonne Hsu
Co Investigator: Peggy Norton
Co Investigator: Jan Baker

Contact Information

Name:Linda Griffen
Phone: 801-581-7038
Email: linda.griffen@hsc.utah.edu

Inclusion Criteria

1) Stage 2 to 4 prolapse[2]
 
2) Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal (POPQ Point C > -TVL/2)
 
3) Vaginal bulge symptoms as indicated by an affirmative response to either questions 4 or 5 of the PFDI:
 
a) Do you usually have a sensation of bulging or protrusion from the vaginal area?
 
b) Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?
 
4) Vaginal surgery for prolapse is planned, including a vaginal apical suspension procedure.
 
5) Stress incontinence symptoms as indicated by an affirmative response to any of the 3 items in the PFDI Stress incontinence subscale:
 
a) Do you usually experience urine leakage related to coughing, sneezing or laughing?
 
b) Do you usually experience urine leakage related to physical exercise such as walking, running, aerobics, or tennis?
 
c) Do you usually experience urine leakage related to lifting or bending over?
 
6) Documentation of transurethral stress leakage on an office stress test or urodynamics with or without prolapse reduction within the previous 12 months
 
7) A TVT is planned to treat stress urinary incontinence.
 
8) A PMT visit can be performed at least 2 weeks and not more than 4 weeks before surgery.
 
9) Available for 24-months of follow-up.
 
10) Able to complete study assessments, per clinician judgment
 
11) Able and willing to provide written informed consent
 

 

Exclusion Criteria

F.1.2. Exclusion Criteria
 
1) Contraindication to SSLF, ULS, or TVT in the opinion of the treating surgeon.
 
2) 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.)
 
3) Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT program.
 
4) History of previous synthetic sling procedure for stress incontinence.
 
5) Previous adverse reaction to synthetic mesh.
 
6) Urethral diverticulum, current or previous (i.e., repaired)
 
7) History of femoral to femoral bypass.
 
8) Current cytotoxic chemotherapy or current or history of pelvic radiation therapy.
 
9) History of two inpatient hospitalizations for medical comorbidities in the previous 12 months.
 
10) Subject wishes to retain her uterus. [Both ULS and SLS include removal of the uterus, if not previously removed]