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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05444023
• Other study ID #: KanuniSSEAH
• Status: Completed
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: March 3, 2024

Study information

• Verified date: March 2024
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 3, 2024
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystocele
• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Pubocervical fascia reconstruction
Suturing type techniques on pubocervical fascia reconstruction at anterior compartment defects.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul
Turkey	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Failure (%)	Recurrence rate	Time Frame: 12 months after intervention
Secondary	Complications	Injury ( bowel, intestinal, blood vessel injuries)	Time Frame: 12 months after intervention
Secondary	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
Secondary	Incontinence Impact Questionnaire (IIQ-7)	evaluating the impact of urinary incontinence	Time Frame: 12 months after intervention
Secondary	Pelvic Floor Distress Inventory (PFDI - 20)	evaluating the bowel, bladder, or pelvic symptoms	Time Frame: 12 months after intervention