Clinical trial NCT03005613: Sacrospinous Ligament Fixation vs Ischial Spine Fascia Fixation
Official title: A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urogenital Prolapse
Keywords: Pelvic organ prolapse
Sacrospinous ligament fixation
Ischial spine fascia fixation
Clinical outcome
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 76
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: objective success
timeFrame: 3 months after operation
Secondary outcomes:
measure: Pelvic Floor Distress Inventory-20 (PFDI-20)
timeFrame: Change from Baseline in PFDI-20 at 3 months and 1 year
measure: Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
timeFrame: Change from Baseline in PFIQ-7 at 3 months and 1 year
measure: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12)
timeFrame: Change from Baseline in PISQ-12 at 3 months and 1 year
measure: complications
timeFrame: through study completion, an average of 1 year
measure: recurrence rate
timeFrame: 3 months after operation
measure: subjective satisfaction ( according to a scale of 5 degrees: significantly worse, worse, no change, improved, greatly improved)
timeFrame: 1 year after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Ob & Gyn, Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Chang Ren, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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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.
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citation: Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1.
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.
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.