Pelvic Organ ProlapseNCT05444023
Comparison of Suturing Technique Types on Pubocervical Fascia at Colpographhy Anterior for Cystocele Repair
A study testing Pubocervical fascia reconstruction in people with Pelvic Organ Prolapse, run by Kanuni Sultan Suleyman Training and Research Hospital at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Pubocervical fascia reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 3 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Women who don't want anterior compartment repair
- Pregnancy
- Age <18 years
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, 34307
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Pubocervical fascia reconstruction
- Keywords
- anterior colporrhaphy, pubocervical fascia, suturing technique, cycstocele, pelvic organ prolapse
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pubocervical fascia reconstructionProcedure or surgery
Suturing type techniques on pubocervical fascia reconstruction at anterior compartment defects.
| Study group | Role | What they receive |
|---|---|---|
| Transverse separated suturing technique | Experimental | During pubocervical fascia reconstruction, the surgeon will perform suturing at the transverse plane with an intermittent stitching technique. Receives: Procedure: Pubocervical fascia reconstruction |
| circular continue suturing technique | Active comparator | During pubocervical fascia reconstruction, the surgeon will perform a continuous stitching technique which includes the lateral parts of the anterior compartment defect. Receives: Procedure: Pubocervical fascia reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective cure rate of prolapse
Provided by the patient's feeling of the "Absence of a bulge in the vagina"
Measured: 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
Measured: Time Frame: 12 months after intervention
Secondary outcomes (6)
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.
Measured: Time Frame: 12 months after intervention
Failure (%)
Recurrence rate
Measured: Time Frame: 12 months after intervention
Complications
İnjury ( bowel, intestinal, blood vessel injuries)
Measured: 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.
Measured: Time Frame: 12 months after intervention
Incontinence Impact Questionnaire (IIQ-7)
evaluating the impact of urinary incontinence
Measured: Time Frame: 12 months after intervention
Pelvic Floor Distress Inventory (PFDI - 20)
evaluating the bowel, bladder, or pelvic symptoms
Measured: Time Frame: 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start15 Nov 2022
- Primary completion15 Nov 2023
- Study completion3 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozan Karadeniz, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444023
- Sponsor's protocol ID
- KanuniSSEAH
- Status last verified
- Mar 2024
- First submitted
- 24 Jun 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Suturing Technique Types on Pubocervical Fascia at Colporrhaphy Anterior for Cystocele Repair
- ClinicalTrials.gov ID
- NCT05444023
- Acronym / sponsor ID
- KanuniSSEAH
- Conditions
- Pelvic Organ Prolapse
- Keywords
- anterior colporrhaphy, pubocervical fascia, suturing technique, cycstocele, pelvic organ prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 3 Mar 2024 (actual)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transverse separated suturing technique | Experimental | Procedure: Pubocervical fascia reconstructionDuring pubocervical fascia reconstruction, the surgeon will perform suturing at the transverse plane with an intermittent stitching technique. |
| circular continue suturing technique | Active comparator | Procedure: Pubocervical fascia reconstructionDuring pubocervical fascia reconstruction, the surgeon will perform a continuous stitching technique which includes the lateral parts of the anterior compartment defect. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pubocervical fascia reconstructionSuturing type techniques on pubocervical fascia reconstruction at anterior compartment defects. | Procedure or surgery | Transverse separated suturing technique, circular continue suturing technique |
Primary outcome
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"
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
6 secondary outcomes
Prolapse-related Quality of life
Time frame: Time Frame: 12 months after intervention
Failure (%)
Time frame: Time Frame: 12 months after intervention
Complications
Time frame: Time Frame: 12 months after intervention
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Time frame: Time Frame: 12 months after intervention
Incontinence Impact Questionnaire (IIQ-7)
Time frame: Time Frame: 12 months after intervention
Pelvic Floor Distress Inventory (PFDI - 20)
Time frame: Time Frame: 12 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pubocervical fascia reconstruction in people with Pelvic Organ Prolapse, run by Kanuni Sultan Suleyman Training and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective cure rate of prolapse (time frame: Time Frame: 12 months after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.