Back to resultsEvaluation of Safety and Efficacy of the Apyx™ Device for the Repair of Pelvic Organ Prolapse (POP)
Primary Purpose
Pelvic Organ Prolapse
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Apyx device
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse
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
Sites / Locations
- Rambam Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Apyx device treatment
Arm Description
The Apyx device enables approximation and fixation of the vaginal apex to the SSL using a deployable anchoring system. Using the device, SSLF can be performed transvaginally without the need for any incisions or blind dissections and without the requirement of heavy anesthesia.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Objective success rate
POP-Q points Ba less than -1 and C less than -½ TVL
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
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
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
Unanticipated Device-related Serious Adverse Event rate
Unanticipated Device-related Serious Adverse Event rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03991455
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Escala Medical LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apyx device treatment
Arm Type
Other
Arm Description
The Apyx device enables approximation and fixation of the vaginal apex to the SSL using a deployable anchoring system. Using the device, SSLF can be performed transvaginally without the need for any incisions or blind dissections and without the requirement of heavy anesthesia.
Intervention Type
Device
Intervention Name(s)
Apyx device
Intervention Description
The Apyx device enables approximation and fixation of the vaginal apex to the SSL using a deployable anchoring system.
Primary Outcome Measure Information:
Title
Change in PFDI-20 Prolapse Subscale (POPDI-6) score
Description
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
Secondary Outcome Measure Information:
Title
Objective success rate
Description
POP-Q points Ba less than -1 and C less than -½ TVL
Time Frame
6 months
Title
Change in PFDI-20
Description
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
Title
Change in PISQ-12 scores
Description
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
Title
PGI-I
Description
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
Title
Unanticipated Device-related Serious Adverse Event rate
Description
Unanticipated Device-related Serious Adverse Event rate
Time Frame
at intervals of 2 weeks, 3 months, 6 months, and 12 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
women with Stage 2-4 apical prolapse who desire uterine preservation.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Safety and Efficacy of the Apyx™ Device for the Repair of Pelvic Organ Prolapse (POP)
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