Pelvic Organs Prolapse Treatment Using Neodymium Laser

Plain-language summary

This study evaluates neodymium laser treatment in women with pelvic organ prolapse. It enrolled women aged 35-50 with mild to moderate (grade I-II) pelvic organ prolapse. This non-phase study is not currently recruiting but is ongoing (active, not recruiting).

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Active, not recruiting

Sponsor

MeLSyTech, Ltd

Intervention

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

Start date

10/3/2021

Estimated completion

4/1/2025

Countries

Russia

Related genes

Locations

• Nizhny Novgorod, Russia

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.