A New Technique for Sacrospinous-Sacrotuberous Fixation for the Treatment of Uterovaginal and Vaginal Vault Prolapse

Ain Shams University

Status: Completed

Conditions: Uterovaginal and Vaginal Vault Prolapse

Treatments: Procedure: Sacrospinous-Sacrotuberous fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT03487328

AS1729

Details and patient eligibility

About

This prospective interventional randomized controlled trial is conducted to compare a new technique for Sacrospinous-Sacrotuberous fixation with the traditional sacrospinous ligament fixation technique for treatment of uterovaginal and vaginal vault prolapse.

Enrollment: 40 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age from 40 to 60 years.
2. POP Q stage III & IV
3. Uterovaginal prolapse.
4. Vaginal vault prolapse.
5. BMI >35.

Exclusion criteria

1. Age > 40 years or < 60 years.
2. POP Q stage I or II.
3. BMI < 35.
4. Previous repair of uterovaginal or vaginal vault prolapse.
5. Comorbidity with Stress Urinary Incontinence.
6. Presence of persistent risk factor increasing intra-abdominal pressure e.g. chronic chest conditions.
7. Any significant comorbidity or psychiatric disorder that would compromise patient's consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Modified technique for Sacrospinous-Sacrotuberous Fixation

Active Comparator group

Description:

Modified technique for Sacrospinous-Sacrotuberous Fixation

Treatment:

Procedure: Sacrospinous-Sacrotuberous fixation

Conventional technique for Sacrospinous-Sacrotuberous Fixation

Active Comparator group

Description:

Modified technique for Sacrospinous-Sacrotuberous Fixation

Treatment:

Procedure: Sacrospinous-Sacrotuberous fixation