Comparison of Suturing Technique Types on Pubocervical Fascia at Colpographhy Anterior for Cystocele Repair

Comparison of Suturing Technique Types on Pubocervical Fascia at Colporrhaphy Anterior for Cystocele Repair

Anterior colporrhaphy is the commonly performed surgery for pelvic organ prolapse. However the success rates of native tissue repair techniques for anterior vaginal prolapse range from %30-%70. According to a systematic review of the anterior colporrhaphy technique, there was no ideal procedure or guideline for gynecologists to perform. The investigators tried to compare pubocervical fascia suturing techniques with the ideal procedure type by determining step by step all parts of the surgery including the anesthesia type. The aim of the study will be to compare the pubocervical fascia reconstruction techniques in the management of anterior compartment defects (POP-Q >2) at 1 year and yearly up to 2 years.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Pubocervical fascia reconstruction

Detailed Description

Primary and secondary endpoints:

Primary outcome measures will be the subjective cure of prolapse ("absence or presence of a bulge in the vagina"), objective success with anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total.

Secondary outcome measures include all other parameters such as perioperative outcomes, patient satisfaction, quality of life outcomes, complications, scores on questionnaires, and reoperations.

The study protocol will be submitted to the institutional review boards of every participating study site and written informed consent will be obtained from all participants on enrolment.

Project design: The investigators will perform an international singlecentre single-blind randomized controlled trial by participating in our tertiary referral hospital.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Kanuni Sultan Suleyman Training and Research Hospital
  • İstanbul, Turkey, 34307
    • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women with symptomatic stage 2 or greater (point C -1 or more pelvic organ prolapse quantification POP-Q) cystocele
• Women aged between 18-75 years of age

Exclusion Criteria:

• Women not eligible for surgery for medical or anesthesiological reasons
• Inability to comprehend questionnaires
• Inability to give informed consent
• Inability to return for a review
• Prior anterior compartment repair with or without mesh
• Severe cardiovascular or respiratory disease
• Women who don't want anterior compartment repair
• Pregnancy
• Age <18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transverse separated suturing technique; During pubocervical fascia reconstruction, the surgeon will perform suturing at the transverse plane with an intermittent stitching technique.	Procedure: Pubocervical fascia reconstruction; Suturing type techniques on pubocervical fascia reconstruction at anterior compartment defects.
Active Comparator: circular continue suturing technique; During pubocervical fascia reconstruction, the surgeon will perform a continuous stitching technique which includes the lateral parts of the anterior compartment defect.	Procedure: Pubocervical fascia reconstruction; Suturing type techniques on pubocervical fascia reconstruction at anterior compartment defects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective cure rate of prolapse	Provided by the patient's feeling of the "Absence of a bulge in the vagina"	Time Frame: 12 months after intervention
Objective success	Defined as anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total	Time Frame: 12 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prolapse-related Quality of life	This will be assessed using a validated questionnaire (Prolapse Quality of Life questionnaire P-QoL) The questionnaire contains 9 domains. Each answer of the patient will have values that range between 1 to 4 or 1 to 5 for the 1st question only). (1 very good 4/5 very poor). There is no overall score. A symptomatic woman might have only one domain impaired and another one might have all domains impaired. We consider both of them symptomatic but in different or same aspects of quality of life. To differentiate different domains, it is important for the decision of our surgery (we will be careful in shortening and narrowing a vagina of a woman who had only a preoperative high (impaired) Personal relationships domain score and other domains in the normal range). This will also help us in the follow up visits.	Time Frame: 12 months after intervention
Failure (%)	Recurrence rate	Time Frame: 12 months after intervention
Complications	İnjury ( bowel, intestinal, blood vessel injuries)	Time Frame: 12 months after intervention
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)	The PISQ-12 is a self-adminestered questionnaire that evaluates sexual function of women with pelvic organ prolapse or urinary incontinence. The questionnaire has 12 items. Other than the first 4 questions that are scored from 4 to 0, all questions are scored from 0 to 4. The total score is calculated with totaling the score of each question. The maximum score is 48. Higher scores show good sexual functioning of women.	Time Frame: 12 months after intervention
Incontinence Impact Questionnaire (IIQ-7)	evaluating the impact of urinary incontinence	Time Frame: 12 months after intervention
Pelvic Floor Distress Inventory (PFDI - 20)	evaluating the bowel, bladder, or pelvic symptoms	Time Frame: 12 months after intervention

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): March 3, 2024

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: pelvic organ prolapse; anterior colporrhaphy; pubocervical fascia; suturing technique; cycstocele
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Prolapse; Pelvic Organ Prolapse; Cystocele
• Other Study ID Numbers: KanuniSSEAH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No