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

Study ID
Study00002362

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Elva Moore
214-645-3833
kelly.moore@utsouthwestern.edu

Principal Investigator
Joseph Schaffer

Summary

Two of the most common vaginal surgeries used to repair apical prolapse are the Sacrospinous Ligament Suspension, called SLS 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. In this trial the subject will be randomized (assigned) to the type of apical prolapse surgery when subject is in the operating room (sealed envelope) either SLS or ULS. Also, subject will be randomized (assigned) to receive pelvic muscle training or usual care before surgery at the Urogynecology clinic (sealed envelope) by research staff.

Participant Eligibility

1)Stage 2 to 4 prolapse
2)Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal
3)Vaginal bulge symptoms as indicated by an affirmative response to either questions 4 or 5 of the PFDI:
a)Does subject usually have a sensation of bulging or protrusion from the vaginal area?
b)Does subject 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)Does subject usually experience urine leakage related to coughing, sneezing or laughing?
b)Does subject usually experience urine leakage related to physical exercise such as walking, running, aerobics, or tennis?
c)Does subject 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 (Spanish speaking subjects will be eligible to participate in the study using a fully translated consent form).
12)18 years or older