Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial

Perineal Tear Resulting From Childbirth Clinical Trial

Official title:

Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02545218
• Other study ID #: StockholmSGH
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2015
• Est. completion date: June 2019

Study information

• Verified date: August 2018
• Source: Stockholm South General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The perineal body is commonly injured during labor. It is possible to perform a secondary repair, a perineorraphy, which aims to reduce the symptomatology after an improperly healed perineal tear. The aim of the randomized trial is to evaluate the results of such an operation compared with conservative treatment.

Description:

A randomized controlled trial which aims to evaluate objective and subjective outcomes following perineorraphy compared with pelvic floor exercise after vaginal delivery. 70 women seeking help for improperly healed perineal tear following vaginal delivery, matching our inclusion- and exclusion criteria, will be randomised into two different treatment groups, 35 to operative treatment, perineorraphy, and 35 to conservative treatment, tutored pelvic floor exercise. Assessment pre-and 6 months postoperatively will include clinical evaluation and condition specific validated questionnaires. Surgical characteristics and adverse events during follow-up are also registered.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: June 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• women with 2nd or 3rd degree laceration during vaginal delivery seeking for help because of troublesome symptoms from the pelvic floor

• height of perineum 2 cm or less.

• A least 6 months post partum

• stopped "exclusive breastfeeding"

• no indication for other gynecological surgical procedure

Exclusion Criteria:

• history of 4th degree laceration

• connective tissue disorder (Systemic lupus erythematosus, Sjögrens syndrome, Polymyalgia rheumatica, Marfans syndrome, Ehlers-Danlos syndrome)

• current use of systemic corticosteroids

• diabetes mellitus

• suspect occult sphincter tear on ultrasound

• history of previous urogynecological operation

Related Conditions & MeSH terms

• Perineal Tear Resulting From Childbirth

Intervention

Procedure:
• Perineorraphy
Surgery for improperly healed perineal tear

Other:
• Pelvic floor exercise
Pelvic floor exercise tutored by physio therapist.

Locations

Country	Name	City	State
Sweden	Södersjukhuset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Harvey MA. Pelvic floor exercises during and after pregnancy: a systematic review of their role in preventing pelvic floor dysfunction. J Obstet Gynaecol Can. 2003 Jun;25(6):487-98. Review. — View Citation

Woodman PJ, Graney DO. Anatomy and physiology of the female perineal body with relevance to obstetrical injury and repair. Clin Anat. 2002 Aug;15(5):321-34. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Global Impression of Improvement (PGI-1)	Patients own assessment of improvement 6 months after intervention using a seven grade assessment tool called PGI-1	6 months after intervention (operation or start of pelvic floor training)
Secondary	POP-Q (Pelvic organ Quantification System)	Pelvic organ prolapse is graded via the Pelvic organ Quantification System (POP-Q) into stage 0-4. It is a validated way to clinically assess and stage of the female pelvic floor.	6 months after intervention (operation or start of pelvic floor training)
Secondary	Ultrasound of perineum	Height and depth of perineum i millimeters using ultrasonography	6 months after intervention (operation or start of pelvic floor training)
Secondary	Pelvic floor distress inventory (PFDI 20)	20 validated questions concerning prolapse related symptoms	6 months after intervention (operation or start of pelvic floor training)
Secondary	Pelvic Floor Impact Questionnaire (PIFQ-7)	Evaluates the effect on quality of lafe.	6 months after intervention (operation or start of pelvic floor training)
Secondary	Prolapse Incontinence Sexual Questionnaire (PISQ)	Evaluate effects on sexual functions	6 months after intervention (operation or start of pelvic floor training)
Secondary	Hospital Anxiety and Depression Scale (HAD)	Evaluate psychological effects	6 months after intervention (operation or start of pelvic floor training)
Secondary	Vaginal symptoms	Three non-validated questions concerning vaginal symptoms; sensation of wideness, vaginal flatulence and excessive discharge.	6 months after intervention (operation or start of pelvic floor training)
Secondary	Surgical complications	Infections.Bleedings. Other complications.	From surgery up to 6 months postoperatively