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NCT Number: NCT05444023

Comparison of Suturing Technique Types on Pubocervical Fascia at Colpographhy 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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey (Türkiye)

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pubocervical fascia reconstruction

Procedure

Suturing type techniques on pubocervical fascia reconstruction at anterior compartment defects.

Primary outcomes

  1. Subjective cure rate of prolapse

    Time frame: Time Frame: 12 months after intervention

    Provided by the patient's feeling of the "Absence of a bulge in the vagina"

  2. Objective success

    Time frame: Time Frame: 12 months after intervention

    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

Secondary outcomes

  1. Prolapse-related Quality of life

    Time frame: Time Frame: 12 months after intervention

    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.

  2. Failure (%)

    Time frame: Time Frame: 12 months after intervention

    Recurrence rate

  3. Complications

    Time frame: Time Frame: 12 months after intervention

    İnjury ( bowel, intestinal, blood vessel injuries)

  4. Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)

    Time frame: Time Frame: 12 months after intervention

    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.

  5. Incontinence Impact Questionnaire (IIQ-7)

    Time frame: Time Frame: 12 months after intervention

    evaluating the impact of urinary incontinence

  6. Pelvic Floor Distress Inventory (PFDI - 20)

    Time frame: Time Frame: 12 months after intervention

    evaluating the bowel, bladder, or pelvic symptoms

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 5, 2022
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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