Hypothesis / aims of study
Urethral Bulking Agent (UBA) injection is currently the second most commonly performed procedure for the treatment of Stress Urinary Incontinence (SUI). It is second only to urethral sling placement. UBA injection is used for incontinence caused by Intrinsic Sphincter Deficiency (ISD). The search for an ideal bulking agent continues, however many agents have been proposed and tested while several of them have been removed from the market due to safety concerns.
Urinary incontinence (UI) is defined as “the complaint of an involuntary leakage of urine.”Urinary incontinence in women results when the brain does not properly signal the bladder, the sphincters do not squeeze strongly enough, or both. The bladder muscle may contract too much or not enough because of a problem with the muscle itself or the nerves controlling the bladder muscle. Damage to the sphincter muscles themselves or the nerves controlling these muscles can result in poor sphincter function. These problems can range from simple to complex. Urinary incontinence is a chronic, bothersome problem that increases with age affecting 50-84% of elderly in long- term care facilities and at any age is more than twice as common in females than in male (1)
Aim of study : To evaluate the efficacy of peri-urethral injection of bulking agent hyaluronic acid Dextranomer gel (NASH.DX)-Urodex in women with stress and mixed urinary incontinence (UI)
Study design, materials and methods
Study (24) women with SUI (19) and mixed UI (5) were included in a prospective, cohort study. in our center GHAZI ALHARIRI HOSPITAL FOR SURGICAL SPECIALITY between NOVEMBER 2016-DECEMBER 2017
Inclusion criteria: were women aged >12y (13-75 year) who had a urodynamic SUI with a Stamey grade of 1-2-3. Patients should have a bladder capacity of ≥300 ml and a postvoid residual of <100 ml. UBA (NASHA/dx) is more suited to persistent SUI after prior anti-incontinence behavior therapy . Patients with advanced age, high anesthetic risk, Other indications include young patients who may desire future pregnancy
Exclusion criteria: were women with pure urgency incontinence is the predominant component, a urodynamically proven detrusor over activity (DO), pelvic organ prolapse (POP), women with a neurogenic bladder or women using an indwelling catheter on a chronic basis. a history of hypersensitivity to the bulking agent (previous injection) and active urinary tract infection
the procedure was assessed pre op using the following tools:
The severity of urinary incontinence was classified using on Stamey scale.
Each patient was evaluated with certain data including age, parity, gynecological history, and medical and surgical history. Clinical evaluation includes physical examination, urinalysis, vaginal examination., Cough test in supine and standing positions urinary leakage at coughing ,The Q-tip tst and Marshal bonney test
.Stamey scale ,as well as the number of pad and incontinence episodes per 24hr. urodynamic study,U.S to evaluate pre and post void , some need flexible cystoscopy use of A.B(3rd generation cephalosporin 1g) one day pre op. stopped of anti- cholinergic 7days before op. and educate the patient about complication.The procedure was done under local anesthesia by UBA (NASH.DX). The patients were followed up before discharge, 1 month 3,6,and 12 month using cough test.
Mean patients age is 44 year (range13-75 year) with a mean parity of 5.5(range from 2-9 child). The mean operating time is14 minutes (ranging from 13-15 minutes). Postoperative complications occur in 4 patients (16.6%). 2 patients have urgency 8.3% and 1patient dysuria 4.16% and one patient failed no patient developed infection at site of injection or hematoma or retention
). All patients had a preoperative positive cough test. One of them single 4.16% the other 23 were married 95.8% and 7pt post menopause 29.16% the other 16 premenopause 66.6% and parity range(2-9child) mean 5.5 the mean operating time 14 minutes (13-15 min) .4 patients had surgical intervention 16.6% (3 hysterectomy + 1anterier.repaire)
5 patients had mixed urinary incontinence 20.8% and 19 patients had SUI 79.1% all patients underwent local anesthesia. The total incidence of postoperative complication was 16.6% (4/24). 2 patients have urgency 8.3% treated with anti-cholinergic drug for 2 weeks and 1patient dysurea 4.16% disappeared after 1 week of treatment with simple analgesic and one patient failed no patient developed infection at site of injection or hematoma or retention, hospitalization 5 hours post operation depended on subsequent satisfactory urinary flow then patients followed up before discharge and 1month, 3month 6month and 12month
22 patients completed the follow-up at 3 months and at 6 months; 2 patient did not complete the 6 months follow up due to loss of contact. The mean Stamey incontinence grade showed a significant decrease from (visitI) at 4weeks (visitII) at 3 months (visit III) at 6month and at 12 months (visit IV). The percentage of patients who were dry 50% at visit I (12/24).stamey G,2,1, change to G0(dry) percentage increased to be 91.6 %at visit II(22/24), 90.9 % at visit III (20/22), and 87.5 % (14/16) at visit IV.4 patients G3 16.6%,15 patients G2 62.5% ,5 patients G1 20% The number of incontinence episodes per day over 7 2 hr before the day of visit showed a significant decrease from >10 to <3 episodes at visit II, at visit III, and visit IV.The number of pads used per 24 hr day showed a significant decrease from 6-7 pad /day to nil at visit II, at visit III, and at visit IV . the 3 patient were have complication (1dysurea,2urgency) after treatment and follow up at visit II show improvement from stamey G3 to G1,and decrease pad from 6 to 3 pad /day,24 hr urinary episodes decrease from 10 to 4 improvemente about 50%.
Interpretation of results
Our study presents the outcome of 12-month follow up after initial treatment of 24 women with SUI and mixed UI using Urodex The results show a successful treatment outcome in terms of efficacy and safety of this new bulking urethral implant. The primary efficacy of our study was successfully achieved as 95.8% of women who participated in the study showed an improvement of their Stamey scale after 3,6,12 months of follow up. The similar to, or even better than, the 12-month outcome of other studies