Evaluating the long-term effects of Splentis for treating pelvic organ prolapse
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
This study is testing how well the Splentis system works for treating uterine prolapse in women over five years, looking at both how they feel and any side effects they might have.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Promedon Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 7 sites (Chemnitz and 6 other locations) |
| Trial ID | NCT05042453 on ClinicalTrials.gov |
What this trial studies
This observational cohort trial aims to assess the long-term efficacy and safety of hysteropexy using the Splentis system for women with primary uterine prolapse. Participants will undergo the procedure via the vaginal route and will be followed for 60 months to evaluate various outcomes, including anatomical success, subjective satisfaction, and the need for re-treatment. Secondary endpoints will focus on functional outcomes such as urinary incontinence, overactive bladder symptoms, quality of life, and sexual health, along with a comprehensive report on any adverse events experienced during the study.
Who should consider this trial
Good fit: Ideal candidates are non-fertile women with primary symptomatic uterine descent and a POP-Q score of 2 or higher scheduled for apical repair.
Not a fit: Patients with recurrent apical prolapse or those with active infections or a history of pelvic cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for women suffering from primary pelvic organ prolapse.
How similar studies have performed: While this approach is being evaluated in this trial, similar studies have shown promising results with other surgical techniques for pelvic organ prolapse.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chemnitz and 6 other locations
- 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)
Study contacts
- Principal investigator: Gert Naumann, MD — Helios Clinic Erfurt, Germany
- Study coordinator: Philipp Schelhorn
- Email: trials.de@promedon.com
- Phone: 00498031900400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.