Pelvic Organs Prolapse Treatment Using Neodymium Laser
Pelvic Organ Prolapse, Female Urogenital Diseases
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Pelvic Organ Prolapse, Colporrhaphy, Neodymium Laser, Laser Treatment, Nanosecond, Laser, Vaginal, Female Urogenital Diseases
Eligibility Criteria
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.
Sites / Locations
- Federal State Budgetary Educational Institution of Higher Education "Privolzhsky Research Medical University" of the Ministry of Health of the Russian FederationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Other
"Magic Max" Laser Treatment + Colporrhaphy
Colporrhaphy (control group 1)
No Treatment (control group 2)
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser. In total, three procedures will be performed with an interval of 4 weeks. During the procedure, the following sequence of actions will be performed: st Stage - vaginal processing with a conical mirror handpiece, nd Stage - vaginal processing with a corner mirror handpiece, d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece. A/R colporrhaphy will be performed 1 month after last laser treatment.
A/R colporrhaphy only will be performed.
Any surgery which do not affect condition of vagina, vulva and paraurethral region will be performed.