Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical and Subjective Symptoms

• Sponsor: Ataturk University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04508062
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 2
• Actual Duration (Months): 21
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: pectopexy operation; Procedure: uterosacral ligaments plication operation.	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 6, 2019
• Actual Primary Completion Date: Jul 6, 2020
• Actual Study Completion Date: Jul 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: pectopexy group this group will only have pectopexy operation	Procedure: pectopexy operation; Vaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides.
Active Comparator: Pectopexy and uterosacral ligaments plication group this group will have pectopexy operation with bilateral uterosacral ligaments plication	Procedure: pectopexy operation; Vaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides.; Procedure: uterosacral ligaments plication operation.; At least 2/3 of the sacrouterine ligaments will be shortened with helical sutures, starting from the cervix and so douglas will be partially obliterated.

Outcome Measures

Primary Outcome Measures

1. questionnaire of lower urinary tract symptoms [changes in symptoms for each title at the preoperative day 1 and postoperative day 3 period]

   the questionaire examines these titles by scoring from one to ten points: sudden feeling of ürination sudden feeling of urination with incontinence Frequent urination Difficulty of starting the urination Abnormal discharge of urine nocturia dyspareunia Stress urinary incontinence dysuria constipation

2. evaluation of sexual function with Women's Sexual Function Index [changes at the preoperative day 1 and postoperative day 40 period]

   Women's Sexual Function Index is a questionnaire about sexual functions of the women. the index definex sexual functions with some questions and scorings.

3. Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification [changes in the stage of apical compartment defect at the preoperative day 1 and postoperative day 3 period according to POP-Q clasification]

   Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification

Secondary Outcome Measures

1. evaluation of sexual function with Women's Sexual Function Index [changes at 3,6 and 12. month after surgery]

   Women's Sexual Function Index is a questionnaire about sexual functions of the women. the index definex sexual functions with some questions and scorings.

2. Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification [changes at 3,6 and 12. month after surgery]

   Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification

3. questionnaire of lower urinary tract symptoms [changes in symptoms for each title at 3,6 and 12. month after surgery]

   the questionaire examines these titles by scoring from one to ten points: sudden feeling of ürination sudden feeling of urination with incontinence Frequent urination Difficulty of starting the urination Abnormal discharge of urine nocturia dyspareunia Stress urinary incontinence dysuria constipation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gamze Nur Cimilli Senocak	Erzurum		Turkey	25100

Sponsors and Collaborators

• Ataturk University

Investigators

• Principal Investigator: Gamze Nur Cimilli Senocak, Ataturk University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gamze Nur Cimilli Şenocak, assistant professor, Ataturk University
• ClinicalTrials.gov Identifier: NCT04508062
• Other Study ID Numbers: B.30.2.ATA.0.01.00/6
• First Posted: Aug 11, 2020
• Last Update Posted: Feb 9, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gamze Nur Cimilli Şenocak, assistant professor, Ataturk University: pelvic organ prolapse; pectopexy; laparoscopy; uterosacral ligaments plication
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Feb 9, 2022