Clinical trial NCT04508062: Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical and Subjective Symptoms
Official title: Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical and Subjective Symptoms in the Treatment of Apical Compartment Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
pectopexy
laparoscopy
uterosacral ligaments plication
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 38
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.

Detailed description: In this study, the investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.

Eligibility criteria: Inclusion Criteria:

* patients with stage II-IV apical compartment defect according to the POP-Q classification

Exclusion Criteria:

* having severe chronic disease that makes the operation dangerous
* patients under 25 and patients over 75 years old

Primary outcomes:
measure: questionnaire of lower urinary tract symptoms
timeFrame: changes in symptoms for each title at the preoperative day 1 and postoperative day 3 period
measure: evaluation of sexual function with Women's Sexual Function Index
timeFrame: changes at the preoperative day 1 and postoperative day 40 period
measure: Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification
timeFrame: changes in the stage of apical compartment defect at the preoperative day 1 and postoperative day 3 period according to POP-Q clasification
Secondary outcomes:
measure: evaluation of sexual function with Women's Sexual Function Index
timeFrame: changes at 3,6 and 12. month after surgery
measure: Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification
timeFrame: changes at 3,6 and 12. month after surgery
measure: questionnaire of lower urinary tract symptoms
timeFrame: changes in symptoms for each title at 3,6 and 12. month after surgery
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Gamze Nur Cimilli Senocak
Study officials:
affiliation: Ataturk University
name: Gamze Nur Cimilli Senocak
role: PRINCIPAL_INVESTIGATOR
References: