Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse

Launched by PROMEDON · Sep 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a treatment called Splentis for women with a condition known as primary apical pelvic organ prolapse, which occurs when pelvic organs drop from their normal position. The trial is looking specifically at how well Splentis works when used to support the uterus through a procedure called hysteropexy. Women aged 65 to 74 who have symptoms related to this condition and are scheduled for this type of surgery may be eligible to participate.

Participants in the trial will have regular check-ups to monitor their progress and understand how well the treatment is working over time. To join, women must be non-fertile and have certain symptoms related to their condition. However, women who are fertile, have had previous surgeries for prolapse, or certain medical issues like infections or cancer are not eligible. This trial is currently recruiting participants, and those who join will be contributing to important research that could help improve care for women dealing with pelvic organ prolapse.

Gender

FEMALE

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.