Effects of vaginal prolapse surgery on innervation of the vagina

Completed

• Conditions: 10029903; Pelvic organ prolapse; 10047789

• Registration Number: NL-OMON37503
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

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

- 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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The effects of prolapse surgery on vaginal nerve density quantified in vaginal<br /><br>epithelial layer biopsies (diameter 4 mm) taken before surgery and at 6 weeks<br /><br>and 6 months after surgery. Biopsies will be taken from the vaginal epithelial<br /><br>layer at both the operated compartment and the opposite vaginal wall. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pelvic floor function measured using the UDI-6, IIQ-7 and PISQ-12<br /><br>questionnaires before and 6 months after surgery. </p><br>