Status:

COMPLETED

Suturing Techniques on Perineal Pain

Lead Sponsor:

University of Oklahoma

Conditions:

Perineal Pain

Eligibility:

FEMALE

18-99 years

Phase:

NA

Brief Summary

Perineorrhaphy, sometimes referred to as perineoplasty, is a common procedure in pelvic reconstructive surgery that entails surgical repair of the perineum. Indications may include: prevention of recu...

Detailed Description

Recruitment will be carried out at OU Medical Center within a 12-month period either at OU Women's Pelvic and Bladder Health Clinic or OU Women's Health Clinic. Women who are planning pelvic organ pro...

Eligibility Criteria

Inclusion

  • Women 18 years or greater planning pelvic floor surgery reconstruction
  • Genital hiatus on POP-Q exam of ≥4 cm

Exclusion

  • History of pelvic radiation
  • History of chronic perineal pain or pudendal neuralgia
  • Planning on having an obliterative vaginal procedure.
  • Concomitant hemorrhoidectomy or colorectal procedure
  • Concomitant mesh removal procedure
  • Allergy to polyglycolic acid sutures
  • History of connective tissue disorder.
  • Chronic immunosuppression

Key Trial Info

Start Date :

October 10 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 9 2023

Estimated Enrollment :

102 Patients enrolled

Trial Details

Trial ID

NCT05264194

Start Date

October 10 2020

End Date

January 9 2023

Last Update

June 13 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104