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Completed

NCT Number: NCT02548858

Perineorrhaphy Outcomes Related to Body Imagery

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico, Albuquerque, New Mexico, United States

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About this study

The objective of this study is to assess the body image of women before and after pelvic reconstructive surgery with and without perineorrhaphy to examine if a perineorrhaphy impacts postoperative body image by conducting a single-blind, randomized controlled clinical trial. The central hypothesis is that patients' body image will not be affected by whether or not a perineorrhaphy is performed.

The target population are those patients with POP who are planning an apical prolapse repair. All participants will give written consent prior to their surgery. After enrollment, women will fill out baseline surveys, including the Body Image in Pelvic Organ Prolapse (BIPOP), the Pelvic organ prolapse/Incontinence Sexual Questionnaire, IUGA-revised) (PISQ-IR), the Pelvic Floor Distress Inventory (PFDI-20), and a Pain Visual Analog Scale (VAS) to assess baseline pain. Additionally, participants will undergo a Pelvic Organ Prolapse Quantification (POP-Q) examination with the addition of measurements of genital hiatus (GH) and perineal body (PB) lengths without strain. The other measurements involved in the POP-Q entail assigning numerical values to descent of different parts of the vagina. Pelvic floor muscle strength will be measured using a Peritron™ perineometer and Kegel strength (contraction of the pelvic floor muscles) using the Oxford grading scale.

On the day of the patient's surgery, the surgeon will call a research coordinator who will open the next envelope in the sequence randomizing the patient to perinorrhaphy or to no perineorrhaphy. Randomization assignment will be generated by a computer-based randomization table and assigned by a research coordinator not otherwise involved in the study. Women will not be informed to what arm of the study they were randomized, and postoperative assessments will be made by individuals not involved with the patient's surgery.

At prescribed time points post-operatively, the patients will be assessed by POP-Q, genital hiatus and perineal body measurements performed with and without strain, the pain VAS, the BIPOP, The PISQ-IR, the PFDI-20, and pelvic floor muscle strength via the Oxford scale and measurement by the Peritron™ perineometer.

The investigators' aims for this study are:

Aim #1: 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. Hypothesis: There will be no difference in body image scores between those with and without concomitant perineorrhaphy.

Aim #2: To determine if Pelvic Organ Prolapse Quantification (POP-Q) measurements are affected by a perineorrhaphy. Hypothesis: After a perineorrhaphy, the genital hiatus (GH) will be smaller, the total vaginal length (TVL) will be longer, the perineal body (PB) will be longer, and all others will be unaffected when compared to those in whom perineorrhaphy is not performed.

Aim #3: To determine if the strength of pelvic floor muscles is improved after corrective pelvic organ prolapse surgery with a perineorrhaphy compared with those patients who did not have a perineorrhaphy, as measured by the Peritron™, a perineometer device that measures pelvic floor muscle contraction strength. Hypothesis: Pelvic floor muscle strength will be unaffected by the performance of a perineorrhaphy.

Aim #4: To assess if those having a perineorrhaphy have higher postoperative pain both in the short term and long term by using a visual analog scale (VAS) both in the immediate and 6 week postoperative period. Hypothesis: Those with perineorrhaphies will report more pain on a VAS both immediately and 6 weeks post-surgery.

Aim #5: To describe if there are differences in sexual function after corrective pelvic organ prolapse with a perineorrhaphy compared to those who did not undergo a perineorrhaphy. Hypothesis: Sexual function will be improved after POP surgery repair but will be unaffected by the performance of a perineorrhaphy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Perineorrhaphy

Procedure

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

No Perineorrhaphy

Procedure

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

Primary outcomes

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

    Time frame: 6 weeks post-operatively

    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.

Secondary outcomes

  1. Pelvic Organ Prolapse Quantification (POP-Q) Measurements

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

    To determine if POP-Q measurements are affected by a perineorrhaphy, as measured immediately post-operatively, and at 1 week, 6 weeks and 3 months after surgery.

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

    Time frame: 6 weeks post-operatively

    To determine if the strength of pelvic floor muscles is improved after corrective pelvic organ prolapse surgery with a perineorrhaphy compared with those who did not have a perineorrhaphy, as measured by the Peritron™ perineometer and digitally.

  3. Post-operative Pain by using a pain visual analog scale

    Time frame: 6 weeks post-operatively

    To assess if those having a perineorrhaphy have higher post-operative pain both in the short term and long term by using a pain visual analog scale both in the immediate and 6 week post-operative period.

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

    Time frame: 3 months post-operatively

    To describe if there are differences in sexual function after correction of pelvic organ prolapse with a perineorrhaphy compared to those that did not undergo a perineorrhaphy. The PISQ-IR is a validated questionnaire that measures sexual function in women with pelvic floor disorders in domains such as arousal, orgasm, partner-related issues, sexual quality, desire, and takes into account those who are not sexually active. The patients will fill out this questionnaire at a baseline visit and at post-operative visits.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

Perineorrhaphy Outcomes Related to Body Imagery (POETRY)

Acronym: POETRY

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 14, 2015
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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