Clinical trial NCT03991455: Evaluation of Safety and Efficacy of the Apyx™ Device for the Repair of Pelvic Organ Prolapse (POP)
Official title: Evaluation of Safety and Efficacy of the Apyx™ Device for the Repair of Pelvic Organ Prolapse (POP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Escala Medical LTD
Sponsor class: INDUSTRY
First posted: 2019-06-19
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Women with prolapse electing to undergo reconstructive vaginal surgery for primary uterovaginal prolapse, who wish to enroll in this trial of an incision-free prolapse repair technique, after being familiarized with the suspected benefits and risks of the procedure.

* Ages 18-90 years old
* POP-Q Stage 2 or greater with an apical support defect, also defined as uterovaginal prolapse
* Desire of uterine preservation
* Patient is willing to return for follow-up evaluation and questionnaire completion at 3 months, 6 months, and 12 months, in addition to routine postoperative standard of care.
* English fluency

Exclusion Criteria:

* Previous vaginal, abdominal, or laparoscopic repair for pelvic organ prolapse
* Prior hysterectomy
* Known allergy to Nitinol / Stainless Steel / Polydioxanone.
* Suspected uterine pathology, including malignancy.
* History of chronic pelvic pain, interstitial cystitis or fibromyalgia.
* Women diagnosed with symptomatic uterine fibroids, cervical elongation or hypertrophy, abnormal uterine or vaginal bleeding.
* History of Pelvic Inflammatory Disease (PID)
* Prior pelvic radiation therapy or malignancy.
* Diagnosis of reproductive tract anomalies.
* Pregnant or lactating women.
* Participation in another trial
* Inability to provide informed consent for study enrollment
* PI's subjective assessment that study procedure will not plausibly correct patient pelvic organ prolapse symptoms due to anatomic considerations

Primary outcomes:
measure: Change in PFDI-20 Prolapse Subscale (POPDI-6) score
timeFrame: 6 months
Secondary outcomes:
measure: Objective success rate
timeFrame: 6 months
measure: Change in PFDI-20
timeFrame: at baseline 3 months, 6 months, and 12 months compared to preoperative
measure: Change in PISQ-12 scores
timeFrame: at baseline 3 months, 6 months, and 12 months compared to preoperative
measure: PGI-I
timeFrame: 3 months, 6 months, and 12 months
measure: Unanticipated Device-related Serious Adverse Event rate
timeFrame: at intervals of 2 weeks, 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
References: