The aim of this study is to further evaluate this minimally invasive SSLF technique with respect to safety, clinical effectiveness, and patient satisfaction. The procedure will be performed in women electing to undergo surgical repair of their prolapse who wish to preserve their uterus, and will be evaluated using standardized measures and questionnaires.
This study will evaluate sacrospinous ligament fixation using an incision-free technique - a technique that was developed with the goal of offering a technically simple, safe, and effective alternative to surgical prolapse repair procedures. When compared to previously reported SSLF methods, this technique has undergone novel modifications with the intent of maximizing efficacy and minimizing invasiveness. First, each sacrospinous ligament is approached trans-vaginally using a small diameter, low profile needle as the delivery platform for the anchoring unit. Secondly, the suspension is bilateral, thus maintaining vaginal length and width without deviation or narrowing of the vagina as might occur with a traditional (unilateral) sacrospinous repair. And third, using bio-degradable sutures and a securing element that stabilizes the fixation as opposed to performing an incision in the vaginal wall for suturing enables an incision-free procedure leaving the vagina free of any device after a period of several weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
The Apyx device enables approximation and fixation of the vaginal apex to the SSL using a deployable anchoring system.
Rambam Medical Center
Haifa, Israel
Change in PFDI-20 Prolapse Subscale (POPDI-6) score
Pelvic Floor Disability Index (PFDI-20) includes 20 questions are rated from 0 to 4, with 0 is no present of distress and 4 is the highest of symptom scale. Pelvic Floor Disability Index distress index is a subscale of the first 6 questions of the above scale
Time frame: 6 months
Objective success rate
POP-Q points Ba less than -1 and C less than -½ TVL
Time frame: 6 months
Change in PFDI-20
Pelvic Floor Disability Index (PFDI-20) includes 20 questions are rated from 0 to 4, with 0 is no present of distress and 4 is the highest of symptom scale
Time frame: at baseline 3 months, 6 months, and 12 months compared to preoperative
Change in PISQ-12 scores
The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire -12 (PISQ-12) includes question for estimation of sexual function for women with POP urinary incontinence and or fecal incontinence
Time frame: at baseline 3 months, 6 months, and 12 months compared to preoperative
PGI-I
Patient Global Impression of Improvement include one question which describes how the patient evaluates the post surgery improvement with a scale of 1 to 7. 1 is very much better and 7 is very much worse
Time frame: 3 months, 6 months, and 12 months
Unanticipated Device-related Serious Adverse Event rate
Unanticipated Device-related Serious Adverse Event rate
Time frame: at intervals of 2 weeks, 3 months, 6 months, and 12 months
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