Comparing the effectiveness and complications of uterosacral and sacrospinous ligament stabilizations for the treatment of pelvic floor disorders
Design
Randomized, Single-blinding clinical trial, with the parallel groups, Phase 2 on 64 patients
Settings and conduct
In this study, 64 patients with pelvic floor disorders presented at Alzahra and Beheshti hospitals in Isfahan are included. They are then randomly divided into two groups. The first group undergoes uterosacral ligament stabilization surgery and the second group undergoes sacrospinous ligament stabilization surgery.
Participants/Inclusion and exclusion criteria
In this study, patients are aged between18 to 75 years with cervical prolapse grade two or more based on the examination, symptomatic prolapse due to protrusion or intestinal or urinary symptoms, not responding to conservative treatments, requesting surgical treatment for prolapse and consent to participate in the study. Exclusion criteria are a contraindication to major surgery or anesthesia, any malignancy in the urinary, genital and pelvic systems, active urinary tract, genital and pelvic infections, and pregnancy and breastfeeding.
Intervention groups
First intervention group: Patients in this group undergo uterosacral ligament stabilization surgery. Second Intervention group: Patients in this group undergo sacrospinous ligament stabilization surgery.
Main outcome variables
Pelvic Floor Distress Inventory; Sexual function; Recurrence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N21
Registration date:2021-01-18, 1399/10/29
Registration timing:prospective
Last update:2021-01-18, 1399/10/29
Update count:0
Registration date
2021-01-18, 1399/10/29
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of uterosacral and sacrospinous ligament stabilization surgeries for the treatment of pelvic floor disorders
Public title
Comparing the effects of two types of surgeries including uterosacral and sacrospinous ligament stabilization for the treatment of pelvic floor disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age between 18 and 75 years old
Cervical prolapse grade two or more based on examination
Symptomatic prolapse for protrusion or intestinal or urinary symptoms
Lack of response to conservative treatments
Demand for surgical treatment for prolapse
Being consent to participate in the study
Exclusion criteria:
Contraindication to major surgery or anesthesia
Existence of any malignancy in the urinary, genital and pelvic systems
Active infection of the urinary, genital and pelvic systems
Pregnancy and breastfeeding
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 64 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the two study groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the present study, the surgeon is aware of the type of surgery in each of the two groups, but the patient and the evaluator (data collector) are not aware of the type of surgery in each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences