Stress Urinary Incontinence
Conditions
Keywords
Urinary Incontinence, Stress, Cystocele, Trans Obturator Tape, Pelvic Organ Prolapse
Brief summary
The goal of this interventional study is to compare the effect of Concurrent cystocele repair and trans obturator tape (TOT) and TOT alone in a sample of Iraqi Female participants with diagnosed stress urinary incontinence and cystocele. The main questions to answer are: 1-What are the effects of the tested Interventions on the outcomes measured by The Pelvic Organ Prolapse Quantification (POP-Q) System? 1. What are the effects of the tested Interventions on the degree of pelvic organ prolapse? 2. What are the effects of the tested Interventions on the frequency, severity, and effect of Stress urinary incontinence on the quality of life of the patients? 3. What are the effects of the tested Interventions on the impact of lower urinary tract symptoms on the quality of the patient's life? Female Patients diagnosed with SUI indicated for intervention were divided into 2 groups Group I: (n=49) offered TOT alone Group II: (n=49) offered concurrent TOT and Cystocele Repair Patients were then followed up and evaluated using The Pelvic Organ Prolapse Quantification (POP-Q) System, The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and the King Health Questionnaire (KHQ). The efficacy of both procedures and their impact on SUI and quality of life was measured.
Interventions
PROCEDURETrans Obturator Tape Procedure (TOT)
Done under Spinal anesthesia in the dorsal lithotomy position.
PROCEDURECystocele Repair
Done under Spinal anesthesia in the dorsal lithotomy position..
Sponsors
Al-Sadr Teaching Hospital
Al-Mustafa University College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Female patients. * Pure stress and/or stress-predominant mixed urinary incontinence (MUI) associated with cystocele. * Had not undergone a previous SUI surgery. * BMI less than 35 kg/m2
Exclusion criteria
* Patients out of the age limit. * Patients refused to participate in the study. * Severe comorbid disease (heart failure HYHA class II and above, etc.). * Patients with a previous surgical history of transvaginal mesh. * Patients suffering detrusor overactivity. * Patients diagnosed with the female genital system or urinary bladder Malignancies. * Patients diagnosed with the presence of neurological disorders that caused voiding dysfunction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Pelvic organ Prolapse (POP-Q) | At baseline, and at 9 months | Assessed using the pelvic organ prolapse quantification system, in which it classified into: 1. Stage 0: No prolapse is observed 2. Stage 1: The most proximal portion of prolapse is greater than 1 cm above the level of the hymen 3. Stage 2: The most proximal portion of prolapse is found between 1 cm higher than hymen and 1cm beneath hymen 4. Stage 3: The most distal part of the prolapse extends more than 1cm beneath the hymen but no further than 2 cm 5. Stage 4: vaginal eversion has taken place or eversion to with 2cm of TVL |
| Frequency, severity, and effect of urine incontinence on quality of life. | At baseline, and at 9 months | Assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF). The score runs from 0 to 21, with higher values indicating more severe illness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of lower urinary tract symptoms including urinary incontinence on health-related quality of life. | At baseline, and after 9 months | Assessed using the King Health Questionnaire (KHQ). It contains ten patient-rated domains. Each score value from 0% (best outcome) to 100% (worst outcome), except for Q10 from 0 to 30 with 30 being the worst. |
Countries
Iraq
Outcome results
None listed