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

A

Ain Shams University

Status

Completed

Conditions

Uterovaginal and Vaginal Vault Prolapse

Treatments

Procedure: Sacrospinous-Sacrotuberous fixation

Study type

Interventional

Funder types

Other

Identifiers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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