Comparison of Two Apical Repair Methods in Women Undergoing Repairs for Prolapse

Quality of Life Clinical Trial

Official title:

Randomized Trial of Sacrospinous Ligament Fixation Versus McCall Culdoplasty in Women Undergoing Vaginal Hysterectomy and Repairs for Prolapse

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03113513
• Other study ID #: V4 31.01.2016
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: April 30, 2025

Study information

• Verified date: January 2024
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To date no study has determined prospectively which technique is superior to prevent recurrent Pelvic Organ Prolapse (POP) after vaginal hysterectomy- a major unmet clinical need. The aim of the study is to determine objective anatomical recurrent prolapse after Sacrospinous Ligament Fixation (SLF) vs McCall.

Description:

The aim of the study is to determine objective anatomical recurrent prolapse after SLF vs McCall. The study is designed as a Randomized Controlled Trial (RCT). Primary study endpoint will be at 12 months, secondary study endpoint at 24 months. The following parameters will be evaluated after one year: anatomical outcome, Quality of Life (QoL), sexual health, reoperations, and complications.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 312
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• declined/ failed conservative treatment for POP

• planned vaginal hysterectomy with anterior/posterior colporrhaphy as indicated

• any symptomatic POP or stage II prolapse in any compartment

• at least stage I prolapse in the apical department

• women between 35 and 80 years of age

• good German language skills

• any concomitant prolapse surgery (anterior, posterior vaginal repair, suburethral tapes) as indicated

• concomitant salpingo-oophorectomy if indicated

Exclusion Criteria:

• Unwillingness to participate

• Neurological disorders

• Previous hysterectomy

• Desire to have children

• Connective tissue disorders (i.e. Ehlers-Danlos syndrome, Marfan syndrome)

Related Conditions & MeSH terms

• Complication
• Pelvic Organ Prolapse
• Prolapse
• Quality of Life
• Surgery

Intervention

Procedure:
• fixation of the vaginal apex
In the course of vaginal hysterectomy the vaginal cuff is either fixed to the sacrospinous ligament or to the uterosacral ligament.

Locations

Country	Name	City	State
Austria	MUGRAZ	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Colombo M, Milani R. Sacrospinous ligament fixation and modified McCall culdoplasty during vaginal hysterectomy for advanced uterovaginal prolapse. Am J Obstet Gynecol. 1998 Jul;179(1):13-20. doi: 10.1016/s0002-9378(98)70245-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with stage 2 or higher on the Pelvic Organ Prolapse Quantification System (POP-Q).	POP-Q stage 2 or higher means any point of the POP-Q system being -1 related to the hymen or below	12 months after surgery
Secondary	Subjective cure	determined by the Patient Global Impression of Improvement (PGII) index	12 months after surgery
Secondary	Quality of life as determined by a questionnaire	The Kings Health Questionnaire was validated in women with stress urinary incontinence and assesses the impact of incontinence on quality of life. The eight subscales ("domains") scored between 0 (best) and 100 (worst). The Symptom Severity scale is scored from 0 (best) to 30 (worst); lower scores indicate better QoL. Success in terms of the study is defined as 10 points improvement on the total Kings Health Questionnaire score.	12 months after surgery
Secondary	Sexual health	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire is a 20 item questionnaire and is the primary measure used to assess sexual function in women with urinary incontinence and prolapse. Mean subscale scores are calculated by summing the valid responses to items in the subscale and then divided by the number of items with valid responses. The higher the subscores, the worse the outcome.	12 months after surgery
Secondary	Reoperation rate	Number of patients with any reoperations for POP	12 months after surgery