Pelvic Floor Function After Obstetric Injury to the Anal Sphincter

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.

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Key information

Conditions

Obstetric Anal Sphincter Injury Anal Incontinence Behavior Behavioral Symptoms Elimination Disorders Encopresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Pathological Conditions, Signs and Symptoms Sexual Dysfunction Sexual Dysfunction, Physiological Signs and Symptoms Signs and Symptoms, Digestive Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0464, Norway

Who can participate

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

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

Treatment and study plan

Obstetric Anal Sphincter Injury

Other

We will investigate if a new vaginal delivery in those with a previous obstetric anal sphincter injury affects the function of anal musculature negatively

Primary outcomes

The long-term impact of a new vaginal delivery on anal sphincter function in women with previous obstetric anal sphincter injury.

Time frame: 5- 20 years

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).

Secondary outcomes

Prevalence of urinary incontinence among women with previous OASI compared to women with similar parity without obstetric anal sphincter injury

Time frame: 5-20 years

Number of participants who report complaints about urinary incontinence, measured by study questionnaires (PFIQ-7, NFIR, PFDI-20).
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.

Time frame: 5-20 years

Number of participants who report complaints about sexual dysfunction, the degree and type og dysfunction will be measured by study questionnaires (PISQ-12)

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

The Pelvic Floor Future Study

Acronym: PFF

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2027
First posted: Apr 27, 2023
Registry last updated: Nov 2, 2023

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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