Sacrospinous Ligament Fixation vs Ischial Spine Fascia Fixation

Urogenital Prolapse Clinical Trial

Official title:

A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03005613
• Other study ID #: RC-H0407-8160061244
• Status: Recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2020

Study information

• Verified date: December 2019
• Source: Peking Union Medical College Hospital
• Contact: Chang Ren, M.D.
• Phone: +86-134-886-988-61
• Email: renchang[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Urogenital Prolapse

Intervention

Procedure:
• ischial spine fascia fixation
The participants will receive ischial spine fascia fixation.
• sacrospinous ligament fixation
The participants will receive sacrospinous ligament fixation.

Locations

Country	Name	City	State
China	Department of Ob & Gyn, Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1. Review. — View Citation

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. — View Citation

Dwyer PL, Lee ET, Hay DM. Obesity and urinary incontinence in women. Br J Obstet Gynaecol. 1988 Jan;95(1):91-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sze EH, Karram MM. Transvaginal repair of vault prolapse: a review. Obstet Gynecol. 1997 Mar;89(3):466-75. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective success	no prolapse, stage I or only asymptomatic stage II prolapse	3 months after operation
Secondary	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
Secondary	Pelvic Floor Impact Questionnaire-7 (PFIQ-7)	to evaluate the quality of life in 3 domains	Change from Baseline in PFIQ-7 at 3 months and 1 year
Secondary	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
Secondary	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
Secondary	recurrence rate	more than asymptomatic stage II prolapse after 3 months	3 months after operation
Secondary	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