Evaluating the long-term effects of Splentis for treating pelvic organ prolapse

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Improving Uroflowmetry: Do Pre-Procedure Reminders Help Women Undergoing Urodynamics

  This study tests whether sending reminder calls before a urodynamics test helps women with pelvic floor disorders feel more prepared and less anxious, and whether it makes the procedure go more smoothly.

  Recruiting Ohio State University · Columbus, Ohio · NCT07692789

• Vaginal Vault Support at Hysterectomy

  This trial tests a new double-ligament vault suspension during hysterectomy to help prevent vaginal apex prolapse in women undergoing the procedure.

  Recruiting Assiut University · Asyut · NCT07517965

• Centered Surgery: Preoperative Counseling to Improve Patient Satisfaction

  This study will test whether virtual group counseling sessions (shared medical appointments) help adults having pelvic organ prolapse surgery feel more satisfied and better prepared compared with standard individual phone calls.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT07471464

• Pelvic floor muscle training with and without hypopressive exercises for women with pelvic organ prolapse

  This will test whether adding hypopressive exercises to pelvic floor muscle training helps women aged 45–65 with stage I–II pelvic organ prolapse improve pelvic floor strength, reduce pain during sex, and feel better overall.

  Recruiting Riphah International University · Lahore, Punjab Province · NCT07440875

• Wrist activity tracking to guide early recovery after pelvic organ prolapse surgery

  This study will try giving women having pelvic organ prolapse surgery either usual postoperative advice or a guided early-exercise plan while tracking activity with a wrist accelerometer to see which group reaches "mostly recovered" sooner.

  Recruiting at 6 sites NICHD Pelvic Floor Disorders Network · San Diego, California and 6 other locations · NCT07218016

• Mesh-free sacrocolpopexy using the VNOTES (transvaginal endoscopic) approach for pelvic organ prolapse

  This trial will try mesh-free sacrocolpopexy using the VNOTES transvaginal endoscopic technique in women with stage II or higher pelvic organ prolapse to see if it improves pelvic support, symptoms, and sexual function over six months.

  Recruiting at 2 sites Gaziosmanpasa Research and Education Hospital · Istanbul and 1 other locations · NCT07114029

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.