Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.
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：
Sample size：76 patients (38 in ISFF group, 38 in SSLF group)
Primary endpoint:
•objective success rates at 3 months after operations.
Secondary endpoints:
Safety endpoints: complications
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sacrospinous ligament fixation group | Active Comparator | The patients will receive sacrospinous ligament fixation operation. |
|
| ischial spine fascia fixation group | Experimental | The patients will receive ischial spine fascia fixation operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ischial spine fascia fixation | Procedure | The participants will receive ischial spine fascia fixation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective success | no prolapse, stage I or only asymptomatic stage II prolapse | 3 months after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Floor Distress Inventory-20 (PFDI-20) | to evaluate the quality of life in 3 domains | Change from Baseline in PFDI-20 at 3 months and 1 year |
| Pelvic Floor Impact Questionnaire-7 (PFIQ-7) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chang Ren, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ob & Gyn, Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3342213 | Background | Dwyer PL, Lee ET, Hay DM. Obesity and urinary incontinence in women. Br J Obstet Gynaecol. 1988 Jan;95(1):91-6. doi: 10.1111/j.1471-0528.1988.tb06486.x. | |
| 9052607 | Background | Sze EH, Karram MM. Transvaginal repair of vault prolapse: a review. Obstet Gynecol. 1997 Mar;89(3):466-75. doi: 10.1016/S0029-7844(96)00337-7. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| sacrospinous ligament fixation | Procedure | The participants will receive sacrospinous ligament fixation. |
|
to evaluate the quality of life in 3 domains
| Change from Baseline in PFIQ-7 at 3 months and 1 year |
| Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) | to evaluate the sexual function | Change from Baseline in PISQ-12 at 3 months and 1 year |
| complications | peri-operative:massive bleeding, organ injury; post-operative: pelvic hematoma, pain, de novo UI, de novo dyspareunia | through study completion, an average of 1 year |
| recurrence rate | more than asymptomatic stage II prolapse after 3 months | 3 months after operation |
| subjective satisfaction ( according to a scale of 5 degrees: significantly worse, worse, no change, improved, greatly improved) | Patient's response as improved or greatly improved | 1 year after operation |
| 9083302 | Background | 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. doi: 10.1016/S0029-7844(97)00058-6. |
| 20966694 | Background | 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. |
| 12548203 | Background | 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. doi: 10.1067/mob.2003.101. |
| 24142057 | Background | Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1. |
| 20223444 | Background | 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. |
| 21060988 | Background | 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. |