Clinical trial NCT05170074: Post-market Clinical Follow-up of the SRS Implant
Official title: National, Multicentre Observational Study on Surgical Reconstruction of the Anterior and Apical Compartment of the Pelvic Floor With a Single-incision, Fixation-free Self-Retaining Support Implant (SRS Implant)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pelvic Organ Prolapse
Keywords: SRS Implant
Quality of Life
Pelvic Organ Prolapse
Surgical Reconstruction
Lead sponsor: pfm medical gmbh
Sponsor class: INDUSTRY
First posted: 2021-12-27
Enrollment: 175
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with a symptomatic anterior vaginal wall prolapse with/without apex/uterine prolapse ≥ stage II (according to POP-Q system), transvaginal SRS implantation for pelvic organ prolapse surgery

Brief summary: National, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant

Detailed description: National, multicentre, prospective observational study on surgical reconstruction of the anterior and apical compartment in seven clinical centres in Germany to obtain post-market information on the SRS implant with a follow-up of 24 months. Patient reported satisfaction (measured by P QoL, Prolapse Quality of Life Questionnaire), anatomic outcome (measured by the POP-Q, Pelvic Organ Prolapse Quantification system) and the rate of complications (measured by adverse events during the study period) are focused.

Eligibility criteria: Inclusion Criteria:

1. Women with a symptomatic anterior vaginal wall prolapse with/without apex/uterine prolapse ≥ stage II (according to POP-Q system). This applies to primary as well as recurrent intervention.
2. Age ≥ 21 years.
3. Patient is mentally able to understand the nature, aims, or possible consequences of the PMCF study.
4. Patient information has been provided and written consent exists.

Exclusion Criteria:

1. Contraindications according to the manufacturer's instructions for use.
2. Patient with previous urogynaecological surgeries with alloplastic material.
3. Patient with radiological treatment in the pelvic floor.
4. Patient is institutionalised by court or official order (MPDG §27).
5. Participation in another interventional study concerning pelvic floor reconstruction.

Primary outcomes:
measure: Patient´s Quality of Life
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bensheim
country: Germany
facility: Heilig Geist-Hospital
state: Hessen
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
city: Hagen
country: Germany
facility: Evangelisches Krankenhaus Hagen-Haspe
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Kiel
country: Germany
facility: Städtisches Krankenhaus Kiel
city: Neustadt
country: Germany
facility: Marienhaus Klinikum Hetzelstift Neustadt/Weinstraße
city: Zittau
country: Germany
facility: Klinikum Oberlausitzer Bergland gGmbH
Study officials:
affiliation: Asklepios Klinik Altona
name: Tina Cadenbach-Blome, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levy G, Padoa A, Marcus N, Beck A, Fekete Z, Cervigni M. Anchorless implant for the treatment of advanced anterior and apical vaginal prolapse - Medium term follow up. Eur J Obstet Gynecol Reprod Biol. 2020 Mar;246:55-59. doi: 10.1016/j.ejogrb.2020.01.005. Epub 2020 Jan 9.
citation: Levy G, Padoa A, Fekete Z, Bartfai G, Pajor L, Cervigni M. Self-retaining support implant: an anchorless system for the treatment of pelvic organ prolapse-2-year follow-up. Int Urogynecol J. 2018 May;29(5):709-714. doi: 10.1007/s00192-017-3415-3. Epub 2017 Jul 14.