Neodimyum Lazer Kullanılarak Pelvik Organ Sarkması Tedavisi

Sade dilde özet

Bu çalışma, pelvik organ sarkması (pelvic organ prolapse) olan kadınlarda neodimyum lazer tedavisini incelemektedir. Çalışmaya, 35-50 yaş arasında, hafif ila orta derecede (I-II derece) pelvik organ sarkması olan kadınlar alınmıştır. Faz uygulanmayan bu çalışma şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz dışı

Durum

Devam ediyor, katılım kapalı

Sponsor

MeLSyTech, Ltd

Müdahale

Laser Treatment, Blood analysis, Сlinical urine test, Electrocardiography, Vaginal smear, Colposcopy, Pelvic ultrasound, Doppler ultrasonography, Vaginal Health Index, Biopsy of the vaginal wall, The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, Pelvic Floor Distress Inventory Questionnaire, International Consultation on Incontinence Questionnaire - Short Form, Pelvic Floor Impact Questionnaire, Anterior and/or posterior colporrhaphy, Pelvic surgical procedure, Physical examination, Сonsultation, Buccal smear

Başlangıç

03.10.2021

Tahmini bitiş

01.04.2025

Ülkeler

Russia

İlgili genler

Merkezler

• Nizhny Novgorod, Russia

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Age 35-50 years old;
* Participants diagnosed with pelvic organ prolapse of I-II degree of severity or any non vaginal diseases which require surgical intervention by the method of laparotomy;
* Participants were examined according to the proposed protocol;
* Participants who signed informed consent and fully informed about the purpose of the study.

Exclusion Criteria:

* Age of under 35 and over 50 years old;
* History of oncological diseases;
* Active tuberculosis;
* Inflammatory diseases of the vulva and vagina including genital herpes in the acute stage;
* Urinary tract infections;
* Damage to the vaginal mucosa;
* Pregnancy;
* Tendency to photoallergy including taking photosensitizing drugs (diuretics, antihistamines, antipsychotics);
* Porphyria;
* Cardiac deficiency of 2-3 degrees;
* Chronic renal disease;
* Diabetes mellitus (type I, II);
* Participants with greater than 2nd grade vaginal prolapse;
* Women after childbirth up to 8 weeks;
* Participants who, according to the doctor, are not able to complete the study;
* Protocol non-compliance of laser exposure sessions;
* Voluntary refusal to participate in the study;
* Violation of recommendations for the management of the period after laser treatment;
* Adverse events that occurred during laser processing and research, and associated with them.
* The occurrence of adverse events or other symptoms that are contraindications to laser procedures, as well as the occurrence of cases described in the exclusion criteria.