Complication, Pelvic Organ Prolapse, Quality of Life, Surgery
Conditions
Brief summary
To date no study has determined prospectively which technique is superior to prevent recurrent Pelvic Organ Prolapse (POP) after vaginal hysterectomy- a major unmet clinical need. The aim of the study is to determine objective anatomical recurrent prolapse after Sacrospinous Ligament Fixation (SLF) vs McCall.
Detailed description
The aim of the study is to determine objective anatomical recurrent prolapse after SLF vs McCall. The study is designed as a Randomized Controlled Trial (RCT). Primary study endpoint will be at 12 months, secondary study endpoint at 24 months. The following parameters will be evaluated after one year: anatomical outcome, Quality of Life (QoL), sexual health, reoperations, and complications.
Interventions
PROCEDUREfixation of the vaginal apex
In the course of vaginal hysterectomy the vaginal cuff is either fixed to the sacrospinous ligament or to the uterosacral ligament.
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study is designed as a RCT.
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* declined/ failed conservative treatment for POP * planned vaginal hysterectomy with anterior/posterior colporrhaphy as indicated * any symptomatic POP or stage II prolapse in any compartment * at least stage I prolapse in the apical department * women between 35 and 80 years of age * good German language skills * any concomitant prolapse surgery (anterior, posterior vaginal repair, suburethral tapes) as indicated * concomitant salpingo-oophorectomy if indicated
Exclusion criteria
* Unwillingness to participate * Neurological disorders * Previous hysterectomy * Desire to have children * Connective tissue disorders (i.e. Ehlers-Danlos syndrome, Marfan syndrome)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with stage 2 or higher on the Pelvic Organ Prolapse Quantification System (POP-Q). | 12 months after surgery | POP-Q stage 2 or higher means any point of the POP-Q system being -1 related to the hymen or below |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective cure | 12 months after surgery | determined by the Patient Global Impression of Improvement (PGII) index |
| Quality of life as determined by a questionnaire | 12 months after surgery | The Kings Health Questionnaire was validated in women with stress urinary incontinence and assesses the impact of incontinence on quality of life. The eight subscales (domains) scored between 0 (best) and 100 (worst). The Symptom Severity scale is scored from 0 (best) to 30 (worst); lower scores indicate better QoL. Success in terms of the study is defined as 10 points improvement on the total Kings Health Questionnaire score. |
| Sexual health | 12 months after surgery | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire is a 20 item questionnaire and is the primary measure used to assess sexual function in women with urinary incontinence and prolapse. Mean subscale scores are calculated by summing the valid responses to items in the subscale and then divided by the number of items with valid responses. The higher the subscores, the worse the outcome. |
| Reoperation rate | 12 months after surgery | Number of patients with any reoperations for POP |
Countries
Austria
Outcome results
None listed