NCT05042453

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
50mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Dec 2022Jul 2030

First Submitted

Initial submission to the registry

August 12, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 19, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

3.5 years

First QC Date

August 12, 2021

Last Update Submit

November 19, 2024

Conditions

Pelvic Organ Prolapse

Keywords

Apical Pelvic Organ ProlapseTransvaginal repairMesh augmented repairSacrouterine ligament fixation

Outcome Measures

Primary Outcomes (1)

  • Cure of apical pelvic organ prolapse

    Cure of apical pelvic organ prolapse is defined according the current recommendations by Barber et al. and ICS/IUGA recommendations. Therefore, a combined endpoint using anatomical, subjective and necessity retreatment criteria are utilized. Primary endpoint is the number of patients achieving all criteria of the composite endpoint: 1. leading edge of the apical vaginal wall at or above the hymen (C≤ 0) 2. absence of a vaginal bulge symptom 3. no need for retreatment of the apical prolapse by either pessary use or surgical intervention

    12 months

Secondary Outcomes (10)

  • Health-related quality of life

    Baseline, 6 weeks 12, 24, 36, 60 months

  • Quality of life

    Baseline, 6 weeks and 12, 24, 36, 60 months

  • Urinary incontinence

    Baseline, 6 weeks and 12, 24, 36, 60 months

  • Overactive Bladder

    Baseline, 6 weeks and 12, 24, 36, 60 months

  • Sexual life

    Baseline, 6 weeks and 12, 24, 36, 60 months

  • +5 more secondary outcomes

Study Arms (1)

Hysteropexy using Splentis via vaginal route

Non-fertile women ≥ 18 years with uterine descent (POP-Q ≥ 2) which are study-independently scheduled for hysteropexy with Splentis

Device: Splentis® POP Tissue Anchoring System

Interventions

Splentis® POP Tissue Anchoring SystemDEVICE

Anterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis

Hysteropexy using Splentis via vaginal route

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Non-fertile women ≥ 18 years with uterine prolapse

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

DRK Hospital Chemnitz-Rabenstein

Chemnitz, Germany

RECRUITING

Helios Hospital Erfurt, Department of gynaecology

Erfurt, Germany

RECRUITING

University Hospital Freiburg

Freiburg im Breisgau, Germany

RECRUITING

Clinic Kassel

Kassel, Germany

RECRUITING

St. Elisabeth Hospital

Leipzig, Germany

RECRUITING

University Hospital

Mannheim, Germany

NOT YET RECRUITING

Hospital Tettnang

Tettnang, Germany

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Gert Naumann, MD

    Helios Clinic Erfurt, Germany

    PRINCIPAL INVESTIGATOR

  • Christian Fünfgeld, MD

    Clinic Tettnang

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philipp Schelhorn

CONTACT

00498031900400trials.de@promedon.com

Lorena López, Ph.D, Bioeng

CONTACT

005493514596072lorena.lopez@promedon.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2021

First Posted

September 13, 2021

Study Start

December 19, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2030

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(7)