Sexual Function After Vaginal Repair With Perineorrhaphy

Vaginal Prolapse Clinical Trial

Official title:

A Randomized Controlled Double-blind Trial Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03333811
• Other study ID #: IRB00036987
• Status: Not yet recruiting
• Phase: N/A
• First received: November 2, 2017
• Last updated: January 3, 2018
• Start date: February 2018
• Est. completion date: June 2018

Study information

• Verified date: November 2017
• Source: Wake Forest University Health Sciences
• Contact: Candace Parker-Autry, MD
• Phone: 336-716-3779
• Email: cparkera[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if perineorrhaphy performed with surgical vaginal prolapse repair improves sexual function.

Description:

The decision to include perineorrhaphy into vaginal prolapse repair is made solely on surgeon preference and personal experience. Little research has been done to explore the short-term and long-term post-operative consequences of perineorrhaphy. This study will explore the effects of perineorrhaphy on post-op sexual function.

Subjects will be randomized to receive a perineorrhaphy in conjunction with their surgical vaginal prolapse repair or to have the surgical repair performed without a perineorrhaphy. At the 6-8 week post op visit, subjects will be asked questions about the presence of genital pain. Subjects will then be given validated symptom and quality of life study questionnaires at 6 and 12 month post op visits to assess sexual function.

Subject partners will be invited to participate after the participant has finalized informed consent. If partner decides to participate, they will complete the a partner questionnaire.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 65
• Est. completion date: June 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with vaginal prolapse to include either apical vaginal prolapse (uterovaginal or vaginal vault), anterior vaginal prolapse, or posterior vaginal prolapse

• Genital hiatus with strain =4 cm, =6 cm measured via standard POPQ examination

• Participates in heterosexual activity at least once/3 months OR desires to be sexually active but limits activity because of prolapse symptoms

• Desires to retain functional vagina (no obliterative procedures)

• Total vaginal length =7 cm

• Scheduled for native tissue vaginal repair of prolapse

• Agreeable to use of vaginal estrogen cream throughout the study period (12 months)

Exclusion Criteria:

• Genital hiatus measured to be >6cm with maximum Valsalva

• Absence of perineal body as measured by PB measurement on POPQ examination of <0.5cm

• Diagnosed with external anal sphincter separation on endoanal ultrasound

• Diagnosed with total procidentia (Stage IV prolapse)

• Obliterative vaginal procedure scheduled

• Atrophic vaginal epithelium AND unable to use intravaginal estrogen

• History of chronic pelvic pain/Interstitial cystitis

Related Conditions & MeSH terms

• Prolapse
• Uterine Prolapse
• Vaginal Prolapse

Intervention

Procedure:
• Perineorrhaphy
Perineorrhaphy is a surgical procedure that aims to re-approximate the disrupted pelvic floor muscles and connective tissue to the midline
• Surgical repair of vaginal prolapse
Surgical correction of Vaginal prolapse

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

References & Publications (4)

Kahn MA, Stanton SL. Posterior colporrhaphy: its effects on bowel and sexual function. Br J Obstet Gynaecol. 1997 Jan;104(1):82-6. — View Citation

Pauls RN, Silva WA, Rooney CM, Siddighi S, Kleeman SD, Dryfhout V, Karram MM. Sexual function after vaginal surgery for pelvic organ prolapse and urinary incontinence. Am J Obstet Gynecol. 2007 Dec;197(6):622.e1-7. — View Citation

Schimpf MO, Harvie HS, Omotosho TB, Epstein LB, Jean-Michel M, Olivera CK, Rooney KE, Balgobin S, Ibeanu OA, Gala RB, Rogers RG; Society of Gynecologic Surgeons Fellows' Pelvic Research Network. Does vaginal size impact sexual activity and function? Int Urogynecol J. 2010 Apr;21(4):447-52. doi: 10.1007/s00192-009-1051-2. Epub 2009 Dec 4. — View Citation

Weber AM, Walters MD, Piedmonte MR. Sexual function and vaginal anatomy in women before and after surgery for pelvic organ prolapse and urinary incontinence. Am J Obstet Gynecol. 2000 Jun;182(6):1610-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sexual function in women who have perineorrhaphy compared to those without perineorrhaphy concomitantly with vaginal repair of prolapse	Female Sexual Function Index (FSFI) is a questionnaire design to measure sexual function in women by assessing the domains of sexual arousal, sexual desire, lubrication, orgasm, satisfaction, and pain. Each question is scored on a scale of 1 to 5; 1 indicating the highest level of difficulty and lowest level of frequency/intensity, and 5 indicating the lowest level of difficulty, and highest possible frequency. A score of zero for a question indicates no sexual activity. The FSFI comes with a scale that provides a domain factor to multiply the sum of the domain scores. Each domain score is then added up for a participants total score with 36 being the maximum and 2.0 being the minimum.	3 months, 6 months, 12 months
Secondary	recurrence rate of pelvic organ prolapse		12 month
Secondary	cross-sectional analysis vaginal introital caliber versus PISQ scores	evaluate the relationship between vaginal introital caliber and the presence of sexual dysfunction in a cross-sectional analysis. The PISQ is the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire designed to evaluate sexual function in women with pelvic organ prolapse and/or urinary incontinence.	12 month
Secondary	Prolapse Questionnaire	The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions	12 month
Secondary	Pain Assessment	Pain Questionnaire is a one question questionnaire that asks subjects to answer yes or no if they experience genital pain. If yes, the subject will then provide an answer to how much the pain bothers them using 4 options; Not at all, Somewhat, Moderately, and Quite a bit.	8 weeks
Secondary	Partner Erectile Function	Participant partners will be invited to participate by providing answers to the IIEF, the International Index of Erectile Function. The IIEF examines the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. A score of 0-5 is given to each question with 0 indicating no sexual activity, 1 indicating the least amount of frequency/satisfaction, and 5 indicating the highest amount of satisfaction/frequency.	12 months