Vaginal vault (apical) prolapse is a condition in which the top of the vaginal wall, and sometimes other areas of the vagina fall, sag or bulge out of their normal position, into or through the opening of the vagina. This condition is common following a hysterectomy (surgical removal of the uterus). This type of prolapse occurs when pelvic muscles, ligaments, and/or tissue become weak, torn or injured and no longer provide adequate vaginal support. Women with prolapse can often feel discomfort, pressure or a bulge at the vaginal opening. These symptoms commonly affect sexual and bodily functions such as urination and bowel movement. Without medical treatment and/or surgery, the bulging and symptoms may eventually get worse.
When women have vaginal vault (apical) prolapse, regular medical care in the United States is to provide conservative treatment (kegel exercises or a pessary device) or to perform one of the various surgical procedures. The choice of which surgery is performed is based on many factors, which may include: physician training, limited information from prior research studies about success rates, symptom relief and possible complications or risks.
The purpose of the “ASPIRe” study is to find out how the results of the surgical procedures compare to each other as well as the advantages and/or disadvantages, risks and benefits, and the effect on quality of life of each surgery when used to repair vaginal vault (apical) prolapse. Physicians can choose from these different types of surgeries to repair vaginal vault (apical) prolapse, but there is not enough information or evidence that demonstrates which surgery provides the best symptom relief and durability while causing the fewest risks.
In this study, investigators are comparing the following three surgical procedures used to repair vaginal vault (apical) prolapse:
- Transvaginal Native Tissue Repair
- Transvaginal Mesh Repair (TVM)
- Sacral Colpopexy
Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable sutures (stitches), to support weakened tissue and/or muscles, and attach the top of the vagina to ligaments in the pelvis (either to the sacrospinous ligament or uterosacral ligament).
Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a graft made of permanent synthetic (man-made) mesh. The mesh is attached to ligaments in the pelvis and is used to reinforce natural tissue and/or muscles, which are no longer able to provide support to the vagina
Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or robot. The surgery is done with a graft made of permanent synthetic (man-made) mesh. The mesh is sutured (stitched) to the vagina and sacrum (tail bone) and is used as reinforcement. It provides additional support to weakened tissues and/or muscles.
Women in this study will be randomly assigned to one of the three prolapse procedures described above. All participating women will complete questionnaires and a physical examination before surgery and then for up to five years after surgery. The data being collected will provide the necessary information for the investigators to make comparisons between the three groups of women to see if there are differences between the surgical procedures.
Some of the questions that the investigators hope to answer by conducting this study include:
- Are the surgical procedures providing equal vaginal support 3-5 years after surgery?
- How do women’s symptoms, quality of life, and physical measures compare after 3-5 years?
- What problems or complications occurred in each group, and are there differences?
- Is the success of surgery influenced by certain characteristics of women, such as severity of prolapse, age, obesity, smoking, menopausal status, estrogens, previous prolapse surgery, and physical activity?
- Is one procedure more cost-effective?
This study will be conducted at multiple sites across the country, beginning in March 2016. Recruitment and surgical procedures will occur over the first two years. Women enrolled in the study will be followed after surgery at 6 weeks and then every 6 months until 60 months (5 years) or 36 months (3 years) post-surgery (depending on enrollment time). The study is expected to continue until February 2021.