Sacrospinous Ligament Fixation vs Ischial Spine Fascia Fixation
Study Details
Study Description
Brief Summary
A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Investigational intervention：SSLF or ISFF operations
Study title：A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.
Principal Investigator：Chang Ren, M.D., Department of Obstetrics & Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.
Study subjects：Adult patients with symptomatic stage II~IV pelvic organ prolapse will be eligible if all the inclusion criteria are met and without any reason for exclusion.
Study objectives：The primary objective of this study is to assess the short and mid-term efficacy of Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation in treating stage II~ IV pelvic organ prolapse and their recurrence rate as well as their impacts on quality of life.
Study design：Prospective, Single-Blind, Randomized, Clinical Trial
Intervention：
-
ISFF group：Patients receive ISFF according to randomization.
-
SSLF group：Patients receive SSLF according to randomization
Sample size：76 patients (38 in ISFF group, 38 in SSLF group)
Primary endpoint:
•objective success rates at 3 months after operations.
Secondary endpoints:
-
peri-operative parameters .
-
subjective satisfactory rates at 1 year after operations
-
quality of life questionnaires at 1 year after operations
Safety endpoints: complications
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: sacrospinous ligament fixation group The patients will receive sacrospinous ligament fixation operation. |
Procedure: sacrospinous ligament fixation
The participants will receive sacrospinous ligament fixation.
|
| Experimental: ischial spine fascia fixation group The patients will receive ischial spine fascia fixation operation. |
Procedure: ischial spine fascia fixation
The participants will receive ischial spine fascia fixation.
|
Outcome Measures
Primary Outcome Measures
- objective success [3 months after operation]
no prolapse, stage I or only asymptomatic stage II prolapse
Secondary Outcome Measures
- Pelvic Floor Distress Inventory-20 (PFDI-20) [Change from Baseline in PFDI-20 at 3 months and 1 year]
to evaluate the quality of life in 3 domains
- Pelvic Floor Impact Questionnaire-7 (PFIQ-7) [Change from Baseline in PFIQ-7 at 3 months and 1 year]
to evaluate the quality of life in 3 domains
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) [Change from Baseline in PISQ-12 at 3 months and 1 year]
to evaluate the sexual function
- complications [through study completion, an average of 1 year]
peri-operative:massive bleeding, organ injury; post-operative: pelvic hematoma, pain, de novo UI, de novo dyspareunia
- recurrence rate [3 months after operation]
more than asymptomatic stage II prolapse after 3 months
- subjective satisfaction ( according to a scale of 5 degrees: significantly worse, worse, no change, improved, greatly improved) [1 year after operation]
Patient's response as improved or greatly improved
Eligibility Criteria
Criteria
Inclusion Criteria:
-
age≤65 years, for those scheduled to receive hysterectomy age≥40 years
-
patients with symptomatic stage II~IV uterine or vaginal vault prolapse
-
receiving SSLF or ISFF in the gynecological department at Peking Union Medical College Hospital
Exclusion Criteria:
-
plans to live abroad within follow-up span
-
contradiction to these two operations: acute genital infection, narrow vagina (less than two finger-breadth), too-ill to receive operations
-
patients with hip joint problem who could not pose a lithotomy position
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Ob & Gyn, Peking Union Medical College Hospital | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Principal Investigator: Chang Ren, M.D., Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1. Review.
- Boyles SH, Weber AM, Meyn L. Procedures for pelvic organ prolapse in the United States, 1979-1997. Am J Obstet Gynecol. 2003 Jan;188(1):108-15.
- Dwyer PL, Lee ET, Hay DM. Obesity and urinary incontinence in women. Br J Obstet Gynaecol. 1988 Jan;95(1):91-6.
- Jones KA, Shepherd JP, Oliphant SS, Wang L, Bunker CH, Lowder JL. Trends in inpatient prolapse procedures in the United States, 1979-2006. Am J Obstet Gynecol. 2010 May;202(5):501.e1-7. doi: 10.1016/j.ajog.2010.01.017. Epub 2010 Mar 11.
- Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6.
- Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.
- Sze EH, Karram MM. Transvaginal repair of vault prolapse: a review. Obstet Gynecol. 1997 Mar;89(3):466-75. Review.
- Zhu L, Lang J, Zhang Q. Clinical study of ischia spinous fascia fixation--a new pelvic reconstructive surgery. Int Urogynecol J. 2011 Apr;22(4):499-503. doi: 10.1007/s00192-010-1307-x.
- RC-H0407-8160061244