Clinical trial NCT05444023: Comparison of Suturing Technique Types on Pubocervical Fascia at Colpographhy Anterior for Cystocele Repair
Official title: Comparison of Suturing Technique Types on Pubocervical Fascia at Colporrhaphy Anterior for Cystocele Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: anterior colporrhaphy
pubocervical fascia
suturing technique
cycstocele
pelvic organ prolapse
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjective cure rate of prolapse
timeFrame: Time Frame: 12 months after intervention
measure: Objective success
timeFrame: Time Frame: 12 months after intervention
Secondary outcomes:
measure: Prolapse-related Quality of life
timeFrame: Time Frame: 12 months after intervention
measure: Failure (%)
timeFrame: Time Frame: 12 months after intervention
measure: Complications
timeFrame: Time Frame: 12 months after intervention
measure: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
timeFrame: Time Frame: 12 months after intervention
measure: Incontinence Impact Questionnaire (IIQ-7)
timeFrame: Time Frame: 12 months after intervention
measure: Pelvic Floor Distress Inventory (PFDI - 20)
timeFrame: Time Frame: 12 months after intervention
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
Study officials:
References: