Pelvic Floor Function After Obstetric Injury to the Anal Sphincter

Urinary Incontinence Clinical Trial

— PFF  

Official title:

The Pelvic Floor Future Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05832268
• Other study ID #: 2019/654
• Status: Enrolling by invitation
• Start date: September 19, 2023
• Est. completion date: March 1, 2027

Study information

• Verified date: October 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The goal of this observational study is to learn more about the effect a pregnancy and delivery has on the function of the anal musculature.We will compare women who had a new delivery after suffering a severe tear in the anal musculature in their first pregnancy, with women who had two or more vaginal deliveries, but did not suffer such an injury.

The main questions we want to answer is:

• can the burden of a new pregnancy and delivery weaken the function of the repaired musculature in a way that might cause symptoms of anal incontinence later in life?

• can a tear in the anal musculature increase the risk of developing urinary incontinence and long term sexual dysfunction?

• should we recommend these women to have a caesarian section instead of a new vaginal delivery?

Participants will be asked to complete an electronic questionnaire with information regarding their pregnancies, deliveries and potential symptoms from anal incontinence, urinary incontinence and sexual dysfunction.

Researchers will compare these two groups to find out if a new vaginal delivery has a negative effect on the function of the anal musculature.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 900
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2025
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sphincter group: Previous obstetric anal sphincter injury during vaginal childbirth in 2002-2018 and having a subsequent vaginal delivery without such injury

• control group: Two or more vaginal deliveries without obstetric anal sphincter injury

Exclusion Criteria:

• under 18 years

• consent incompetency

• Obstetric anal sphincter injury in subsequent pregnancies

• caesarian section in subsequent pregnancy

Related Conditions & MeSH terms

• Anal Incontinence
• Fecal Incontinence
• Obstetric Anal Sphincter Injury
• Sexual Dysfunction
• Urinary Incontinence

Intervention

Other:
• Obstetric Anal Sphincter Injury
We will investigate if a new vaginal delivery in those with a previous obstetric anal sphincter injury affects the function of anal musculature negatively

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The long-term impact of a new vaginal delivery on anal sphincter function in women with previous obstetric anal sphincter injury.	Number of participants with previous OASI who had a new vaginal delivery will be compared to participants with similar parity, without previous OASI. Differences in anal incontinence symptom score and quality of life will be measured by study questionnaires (St. Marks score, PFDI-20 and PFIQ-7).	5- 20 years
Secondary	Prevalence of urinary incontinence among women with previous OASI compared to women with similar parity without obstetric anal sphincter injury	Number of participants who report complaints about urinary incontinence, measured by study questionnaires (PFIQ-7, NFIR, PFDI-20).	5-20 years
Secondary	The risk of long- term dyspareunia and sexual dysfunction after previous obstetric anal sphincter injury compared to women with similar parity without obstetric anal sphincter injury.	Number of participants who report complaints about sexual dysfunction, the degree and type og dysfunction will be measured by study questionnaires (PISQ-12)	5-20 years