Clinical trial NCT05042453: Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse
Official title: Prospective, Multicenter, 60 Months, Single-arm Cohort Trial for Evaluation of the Efficacy and Safety of Transvaginal Sacrospinous Ligament Fixation With Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Organ Prolapse
Keywords: Apical Pelvic Organ Prolapse
Transvaginal repair
Mesh augmented repair
Sacrouterine ligament fixation
Lead sponsor: Promedon
Sponsor class: INDUSTRY
First posted: 2021-09-13
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-fertile women ≥ 18 years with uterine prolapse

Brief summary: This prospective, multi center cohort trial aims to evaluate the efficacy and safety of hysteropexy using Splentis via the vaginal route in primary uterine prolapse

Detailed description: Women who undergo hysteropexy with Splentis via the vaginal route for primary uterine prolapse will be evaluated regarding efficacy and safety in a long term follow-up of 60 months. The primary endpoint is composed of anatomical, subjective and re-treatment components, whereas several secondary endpoints focusing on functional outcome including overactive bladder symptoms, urinary incontinence, quality of life and sexual life will be considered. Furthermore, a detailed report about adverse events will be included.

Eligibility criteria: Inclusion Criteria:

* non-fertile women
* primary symptomatic uterine descent POP-Q≥2
* Scheduled apical POP repair with Splentis
* Willing and able to participate at study visits and to sign informed consent

Exclusion Criteria:

* Fertile women
* Recurrent apical prolapse
* Women with post hysterectomy vaginal vault prolapse
* Patients with active or latent infection of the vagina, cervix or uterus
* Patients with previous or current vaginal, cervical or uterine cancer
* Previous, current or planned pelvic radiation therapy
* Known allergy to polypropylene.

Primary outcomes:
measure: Cure of apical pelvic organ prolapse
timeFrame: 12 months
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Baseline, 6 weeks 12, 24, 36, 60 months
measure: Quality of life
timeFrame: Baseline, 6 weeks and 12, 24, 36, 60 months
measure: Urinary incontinence
timeFrame: Baseline, 6 weeks and 12, 24, 36, 60 months
measure: Overactive Bladder
timeFrame: Baseline, 6 weeks and 12, 24, 36, 60 months
measure: Sexual life
timeFrame: Baseline, 6 weeks and 12, 24, 36, 60 months
measure: Pain according Visual analogue scale of pain
timeFrame: Baseline, 24-48 hours postoperatively, 6 weeks and 12, 24, 36, 60 months
measure: Patient global impression of improvement
timeFrame: 6 weeks and 12, 24, 36, 60 months
measure: Cure according composite endpoint
timeFrame: 6 weeks and 24, 36, 60 months
measure: Adverse Events
timeFrame: Intraoperatively, 24-48hours postoperatively, 6 weeks postoperatively and 12, 24, 36, 60 months, unscheduled visits
measure: Exposure and extrusion free survival
timeFrame: 6 weeks and 12, 24, 36, 60 months
Other outcomes:
Locations:
city: Chemnitz
country: Germany
facility: DRK Hospital Chemnitz-Rabenstein
city: Erfurt
country: Germany
facility: Helios Hospital Erfurt, Department of gynaecology
city: Freiburg
country: Germany
facility: University Hospital Freiburg
city: Kassel
country: Germany
facility: Clinic Kassel
city: Leipzig
country: Germany
facility: St. Elisabeth Hospital
city: Mannheim
country: Germany
facility: University Hospital
city: Tettnang
country: Germany
facility: Hospital Tettnang
Study officials:
affiliation: Helios Clinic Erfurt, Germany
name: Gert Naumann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic Tettnang
name: Christian Fünfgeld, MD
role: PRINCIPAL_INVESTIGATOR
References: