NCT02548858

Brief Summary

The purpose of this study is to determine whether performing a perineorrhaphy during a reconstructive surgery indicated for pelvic organ prolapse (POP) affects a patient's body image.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

March 4, 2019

Status Verified

March 1, 2019

Enrollment Period

1.8 years

First QC Date

September 8, 2015

Last Update Submit

March 1, 2019

Conditions

Pelvic Organ Prolapse

Keywords

PerineorrhaphyPelvic organ prolapseVaginal or abdominal reconstructionBody image

Outcome Measures

Primary Outcomes (1)

  • Body Image, by using the Body Image in Pelvic Organ Prolapse (BIPOP) questionnaire

    To determine if a patient's body image, by using the Body Image in Pelvic Organ Prolapse (BIPOP) questionnaire, is affected by concomitant performance of a perineorrhaphy at the time of pelvic organ prolapse surgery.

    6 weeks post-operatively

Secondary Outcomes (4)

  • Pelvic Organ Prolapse Quantification (POP-Q) Measurements

    Pre-operatively, in the operating room, 1 week, 6 weeks, and 3 months post-operatively

  • Pelvic Floor Muscle Strength as measured by the Peritron™ perineometer and digitally.

    6 weeks post-operatively

  • Post-operative Pain by using a pain visual analog scale

    6 weeks post-operatively

  • Sexual Function, as measured by the validated questionnaire, PISQ-IR

    3 months post-operatively

Study Arms (2)

Perineorrhaphy

ACTIVE COMPARATOR

Patients who are randomized to receive a perineorrhaphy as part of their vaginal or abdominal reconstructive procedure

Procedure: Perineorrhaphy

No Perineorrhaphy

ACTIVE COMPARATOR

Patients who are randomized not to receive a perineorrhaphy as part of their vaginal or abdominal reconstructive procedure

Procedure: No Perineorrhaphy

Interventions

PerineorrhaphyPROCEDURE

Those patients who are randomized to undergo a perineorrhaphy as part of their vaginal or abdominal reconstructive procedure for pelvic organ prolapse.

Perineorrhaphy
No PerineorrhaphyPROCEDURE

Those patients who are randomized not to undergo a perineorrhaphy as part of their vaginal or abdominal reconstructive procedure for pelvic organ prolapse.

No Perineorrhaphy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects ≥ 18 years of age
  • Symptomatic POP who desire vaginal or abdominal apical suspension
  • English-speaking/reading
  • Genital hiatus measurement \< 6 cm, \>2cm

You may not qualify if:

  • Those who desire colpocleisis
  • Those whose surgical planning includes levatorplasty
  • Genital hiatus measurements greater than or equal to 6 cm, \< 2 cm
  • Inability to speak/understand English
  • Those who specifically request a perineorrhaphy
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Sandoval Regional Medical Center

Rio Rancho, New Mexico, 87144, United States

Location

Related Publications (1)

  • Ninivaggio CS, Komesu YM, Jeppson PC, Cichowski SB, Qualls C, Qeadan F, Rogers RG, Dunivan GC. Perineorrhaphy Outcomes Related to Body Imagery: A Randomized Trial of Body Image Perception. Female Pelvic Med Reconstr Surg. 2021 May 1;27(5):281-288. doi: 10.1097/SPV.0000000000000841.

    PMID: 32205557DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Cara S Ninivaggio, MD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urogynecology Fellow, University of New Mexico

Study Record Dates

First Submitted

September 8, 2015

First Posted

September 14, 2015

Study Start

August 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

March 4, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)