An interventional study of total laparoscopic hysterectomy with sacrocolpopexy and total laparoscopic hysterectomy with lateral suspension in Pelvic Organ Prolapse, sponsored by Antalya Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2021-02-12.
Sponsored by Antalya Training and Research Hospital · Not applicable, Interventional, and Treatment
This prospective randomized surgical trial is designed to compare objective and subjective outcomes of total laparoscopic hysterectomy with sacrocolpopexy versus total laparoscopic hysterectomy with lateral suspension for the treatment of pelvic organ prolapse
676 studies on the registry are indexed under Prolapse; 79 are open to participants now.
This study's enrollment of 80 is close to the median of 74 across 435 interventional studies indexed under Prolapse.
Browse Prolapse studies →Antalya Training and Research Hospital is the lead sponsor of 102 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
total laparoscopic hysterectomy with sacrocolpopexy will be performed
Procedure: total laparoscopic hysterectomy with sacrocolpopexy
total laparoscopic hysterectomy with lateral suspension will be performed
Procedure: total laparoscopic hysterectomy with lateral suspension
Surgical correction of anterior and/or apical pelvic organ prolapse by laparoscopy
Surgical correction of anterior and/or apical pelvic organ prolapse by laparoscopy
Rate of objective cure
Recurrences of vaginal vault prolapse will be assessed as objective cure by using the pelvic organ prolapse quantification (POP-Q) system
Time frame: 12 months
Patient Global Impression of Improvement (PGI-I)
Patient Global Impression of Improvement scale is global index that may be used to rate the response of a condition to a therapy. It is a 7-point scale where a score of 1 indicates that the patient is "very much improved," a score of 4 indicates that the patient has experienced "no change," and a score of 7 indicates that the patient is "very much worse."
Time frame: 12 months
International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)
The questionnaire contains four items: frequency of urinary incontinence, amount of leakage, overall impact of urinary incontinence and self-diagnostic. The first item has 6 response categories (never, once a week, two or three times a week, once a day, a few times a day, always) and is scored from 0 to 5. The second item has 4 response categories (none, small amount, moderate amount, large amount) and is scored 0, 2, 4, or 6. The third item (how much urine leakage affects your daily life) has 5 response (not at all, mildly, moderately, severely, to a great extent) and is scored from 0 to 10. The first three items are scored and then summed to produce a total score, ranging from 0 to 21. The last item is a diagnostic item to assess the perceived cause of incontinence. This item is included upon the request of clinicians and is not used for scoring. A higher ICIQ-UI-SF score indicates higher frequency, severity, and lower quality of life.
Time frame: 12 months
International Consultation on Incontinence Questionnaire on Vaginal Symptoms (ICIQ-VS)
The questionnaire evaluates several pelvic floor dysfunctions including questions regarding intestinal, vaginal, sexual symptoms and quality of life impact. It includes 14 questions (dragging abdominal pain, vaginal soreness, reduced sensation around vagina, vagina too loose/lax, lump coming down in vagina, lump coming out of vagina, dry vagina, digitation for bowel opening, tight vagina, current sex life, worries about vagina affect sex life, relationship, sex life spoilt, overall impact on everyday life) and divided into three independent domains. Vaginal symptoms score varies from 0 to 53. Sexual symptoms score varies from 0 to 58. Quality of life impact score varies from 0 to 10. Usually each question has 3 to 5 possible answers; the higher the score, the most severe is the symptom or the negative quality of life impact.
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Antalya Training and Research Hospital