Effects of vaginal prolapse surgery on innervation of the vagina

Effects of vaginal prolapse surgery on innervation of the vagina - VIVA trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37503

Enrollment

Registered

2012-06-19

Start date

2012-07-16

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic organ prolapse

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients undergoing primary prolapse surgery because of vaginal prolapse stage * 2 in either the anterior or posterior compartment. - Sexually active women, sexually active meaning: o Patients who are sexually active before surgery o Patients who are not sexually active before surgery but plan to become sexually active after surgery

Exclusion criteria

Exclusion criteria: - Previous pelvic surgery - Previous pelvic irradiation - Unwilling to return for follow-up or language barriers - Presence of immunological / haematological disorders interfering with recovery after surgery - Neurologic disorders, neuropathy - Abnormal ultrasound findings of uterus or ovaries.

Design outcomes

Primary

Measure	Time frame
The effects of prolapse surgery on vaginal nerve density quantified in vaginal epithelial layer biopsies (diameter 4 mm) taken before surgery and at 6 weeks and 6 months after surgery. Biopsies will be taken from the vaginal epithelial layer at both the operated compartment and the opposite vaginal wall.	—

Secondary

Measure	Time frame
Pelvic floor function measured using the UDI-6, IIQ-7 and PISQ-12 questionnaires before and 6 months after surgery.	—

Countries

Netherlands

Outcome results