Clinical trial NCT02548858: Perineorrhaphy Outcomes Related to Body Imagery
Official title: Perineorrhaphy Outcomes Related to Body Imagery (POETRY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Perineorrhaphy
Pelvic organ prolapse
Vaginal or abdominal reconstruction
Body image
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Image, by using the Body Image in Pelvic Organ Prolapse (BIPOP) questionnaire
timeFrame: 6 weeks post-operatively
Secondary outcomes:
measure: Pelvic Organ Prolapse Quantification (POP-Q) Measurements
timeFrame: Pre-operatively, in the operating room, 1 week, 6 weeks, and 3 months post-operatively
measure: Pelvic Floor Muscle Strength as measured by the Peritron™ perineometer and digitally.
timeFrame: 6 weeks post-operatively
measure: Post-operative Pain by using a pain visual analog scale
timeFrame: 6 weeks post-operatively
measure: Sexual Function, as measured by the validated questionnaire, PISQ-IR
timeFrame: 3 months post-operatively
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Rio Rancho
country: United States
facility: Sandoval Regional Medical Center
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Cara S Ninivaggio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.