Hysterectomy or Uphold Uterine Conservation in women with apical prolapse – a Comparative Trial (HUUT)

Not Applicable

Recruiting

• Conditions: symptomatic uterine prolapse; Renal and Urogenital - Other renal and urogenital disorders; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12611000633987
• Lead Sponsor: Southern Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 114

Inclusion Criteria

patients with POP (Pelvic Organ Prolapse) Stage >2 symptomatic uterine descent referred for surgery

Exclusion Criteria

1. Unevaluated dysfunctional (or post menopausal) menstrual bleeding 2. Unevaluated cervical smears abnormality 3. Non compliant to cervical screening 4. Evidence of endometrial or cervical (including high grade precancerous lesions) malignancy 5. Family incomplete 6. Previous synthetic mesh used for POP 7. Previous uterine suspension 8. History of chronic pelvic pain, including interstitial cystitis 9. Unwilling to undergo hysterectomy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of apical POP (pelvic organ prolapse) stage >2 (Point C below -1cm)[12 months after surgery<br>36 months after surgery]

Secondary Outcome Measures

Name	Time	Method
Incidence of overall POP stage >2[12 months after surgery<br>36 months after surgery];Change in Subjective symptoms score (PFDI 20)[12 months after surgery<br>36 months after surgery];Change in impact / quality of life (PFIQ 7)[12 months after surgery<br>36 months after surgery];Change in sexual functioning (PISQ 12)[12 months after surgery<br>36 months after surgery];Change in overall / global impression of improvement (PGI I)[12 months after surgery<br>36 months after surgery]