The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safe… (NCT05422209) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair.
Russia310 participantsStarted 2022-09-09
Plain-language summary
This is a prospective randomized controlled study, designed to assess the influence of posterior colporrhaphy and perineoplasty performed simultaneously with mesh-augmented sacrospinal fixation (apical sling) in advanced pelvic organ prolapse repair.
Who can participate
Age range
45 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The age of a subject is 45 to 80 years.
* Leading point of prolapse is at the level of the hymen or distal to the hymen (Ba, C\>=0 according to POP-Q classification)
* Patient's ability to read and sign the informed consent form.
* Socialized patient who is able to fill in validated questionnaires and arrive for control postoperative examination in future.
* Patient's consent for participation in the study.
Exclusion Criteria:
* The subject has presence of oncologic disease which was diagnosed earlier or is active now.
* The subject had prior surgery for POP, SUI or hysterectomy
* The subject has gynecological deseases (recurrent uterine bleeding, endometrial hyperplasia, the presence of atypical cells in cervical smears, adenomyosis, multiple uterine myoma)
* The subject has urinary incontinence
* The subject is planning pregnancy
* The subject has an active urinary tract infection or skin infection in the region of surgery or acute infectious desease
* The subject is unable to visit postoperative check-ups
* Refusal from participation.
* Bp \> C according to POP-Q system.
* gh \< 4 cm and \> 6 cm according to POP-Q system.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.