2. Methods
A prospective study was conducted at the Soroka University Medical
Center (SUMC), in accordance with the provisions of the Declaration of
Helsinki (Soroka University Medical Center IRB approval 0186-19). SUMC
is a large tertiary teaching center, treating a population of close to a
million residents of southern Israel. The study population included
patients who underwent a TOT procedure to treat SUI or
stress-predominant mixed urinary incontinence, were over the age of 18
years, and were able to walk without support. Exclusion criteria
included patients with congenital deformity or other diseases of the hip
joint, those who have undergone previous surgeries of the hip joints or
were using wheeled mobility devices. Patients with previous SUI
surgeries were excluded as well. Participants were recruited before
surgery, after they were provided with a verbal explanation of the study
rationale and signed an informed consent form. Participants background
characteristics were collected from the electronic medical records
including demographics (age, ethnicity, city of residence, years of
formal education) and general, surgical, and obstetrical history
(menopause status, background chronic medical conditions, number of
previous pregnancies and deliveries, weight, height, smoking). Surgical
information that was collected included estimated blood loss during
surgery, duration of surgery, concomitant procedures undertaken during
the TOT operation (e.g., colporrhaphy, hysterectomy, sacrospinous
ligament fixation) and perioperative complications.
To assess lower extremity function after surgery, the following
measurement were taken and tests performed at baseline and 6-8 weeks
following surgery, by a licensed and experienced physical therapist:
- Range of motion and hip joint function in both hips including flexion,
extension, external rotation, and internal rotation, measured using a
Goniometer (14).
- Manual strength testing of the hip joint muscles involved in flexion,
adduction, and abduction. Grading was on a 0 to 5 Medical Research
Council scale (15), were ”0” represents no muscle contraction, and ”5”
represents normal muscle strength (able to overcome full resistance),
and the numeric grades in-between represent raising levels of
contraction against resistance.
- Validated condition-specific quality-of-life (QoL):
Urogenital Distress Inventory
(UDI-6) questionnaire to evaluate the QoL and symptom distress in
patients suffering from urinary incontinence (16) and the
Incontinence Impact
Questionnaire short form 7
(IIQ-7) to measure the impact of
urinary incontinence on activities, roles, and emotional states in
patients (17).
- To examine mental and physical quality of life we used the 12-Item
Short Form Survey (SF-12) (18, 19).
- The Forgotten Joint Score (FJS) questionnaire was used to assess the
ability of the patient to forget having a problem with a certain joint
following surgery (20, 21).
- ”Get Up and Go” test (22, 23)
and the 10-Meter Walk Test (10mWT) (24) were used to assess gait
performance. During the former, the patient is observed while rising
from a chair, walking a short distance, turning around, and sitting
back on the chair. The 10mWT assesses walking speed over a fixed
distance.
- Direct measurement of leg length, measuring the distance between the
anterior superior iliac spine (ASIS) and the medial malleolus (25,
26).