Perineal Tear Resulting From ChildbirthNCT02545218
Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial
A study testing Perineorraphy and Pelvic floor exercise in people with Perineal Tear Resulting From Childbirth, run by Stockholm South General Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perineal Tear Resulting From Childbirth
- What is being tested?
- Perineorraphy and Pelvic floor exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2015to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Perineal Tear Resulting From Childbirth
- Being tested
- Perineorraphy, Pelvic floor exercise
- Keywords
- Perineum. Perineorraphy. Pelvic floor exercise.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerineorraphyProcedure or surgery
Surgery for improperly healed perineal tear
Pelvic floor exerciseOther
Pelvic floor exercise tutored by physio therapist.
| Study group | Role | What they receive |
|---|---|---|
| Perineorraphy. | Active comparator | Secondary surgical repair of the perineal body. Operation is performed by a urogynecologist in an operation theater in local anesthesia. The operation aims to re-create the anatomy in the injured perineum using 2-4 sutures. Receives: Procedure: Perineorraphy |
| Pelvic floor exercise. | Active comparator | Tutored pelvic floor exercise. A trained physio therapist evaluate the pelvic floor musculature and helps the patient to perform proper pelvic floor exercises using biofeedback. The patient receives a training scheme and meets the therapist regularly every second week during 4 months. Receives: Other: Pelvic floor exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after intervention (operation or start of pelvic floor training)
Secondary outcomes (8)
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.
Measured: 6 months after intervention (operation or start of pelvic floor training)
Ultrasound of perineum
Height and depth of perineum i millimeters using ultrasonography
Measured: 6 months after intervention (operation or start of pelvic floor training)
Pelvic floor distress inventory (PFDI 20)
20 validated questions concerning prolapse related symptoms
Measured: 6 months after intervention (operation or start of pelvic floor training)
Pelvic Floor Impact Questionnaire (PIFQ-7)
Evaluates the effect on quality of lafe.
Measured: 6 months after intervention (operation or start of pelvic floor training)
Prolapse Incontinence Sexual Questionnaire (PISQ)
Evaluate effects on sexual functions
Measured: 6 months after intervention (operation or start of pelvic floor training)
Hospital Anxiety and Depression Scale (HAD)
Evaluate psychological effects
Measured: 6 months after intervention (operation or start of pelvic floor training)
Vaginal symptoms
Three non-validated questions concerning vaginal symptoms; sensation of wideness, vaginal flatulence and excessive discharge.
Measured: 6 months after intervention (operation or start of pelvic floor training)
Surgical complications
Infections.Bleedings. Other complications.
Measured: From surgery up to 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2018
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Perineal Tear Resulting From ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stockholm South General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marion Ek, Stockholm South General Hospital
- Investigators
- Marion Ek, M.D., Ph.D., Principal investigator, Stockholm South General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545218
- Sponsor's protocol ID
- StockholmSGH
- Status last verified
- Aug 2018
- First submitted
- 7 Sep 2015
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1002/ca.10034.
PubMed 12203375Harvey 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. doi: 10.1016/s1701-2163(16)30310-3.
PubMed 12806450Bergman I, Westergren Soderberg M, Ek M. Perineorrhaphy Compared With Pelvic Floor Muscle Therapy in Women With Late Consequences of a Poorly Healed Second-Degree Perineal Tear: A Randomized Controlled Trial. Obstet Gynecol. 2020 Feb;135(2):341-351. doi: 10.1097/AOG.0000000000003653.
PubMed 31923073
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial
- ClinicalTrials.gov ID
- NCT02545218
- Acronym / sponsor ID
- StockholmSGH
- Conditions
- Perineal Tear Resulting From Childbirth
- Keywords
- Perineum. Perineorraphy. Pelvic floor exercise.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Stockholm South General HospitalUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2019 (estimated)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineorraphy. | Active comparator | Procedure: PerineorraphySecondary surgical repair of the perineal body. Operation is performed by a urogynecologist in an operation theater in local anesthesia. The operation aims to re-create the anatomy in the injured perineum using 2-4 sutures. |
| Pelvic floor exercise. | Active comparator | Other: Pelvic floor exerciseTutored pelvic floor exercise. A trained physio therapist evaluate the pelvic floor musculature and helps the patient to perform proper pelvic floor exercises using biofeedback. The patient receives a training scheme and meets the therapist regularly every second week during 4 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PerineorraphySurgery for improperly healed perineal tear | Procedure or surgery | Perineorraphy. |
| Pelvic floor exercisePelvic floor exercise tutored by physio therapist. | Other | Pelvic floor exercise. |
Primary outcome
Patient Global Impression of Improvement (PGI-1)
Time frame: 6 months after intervention (operation or start of pelvic floor training)
Patients own assessment of improvement 6 months after intervention using a seven grade assessment tool called PGI-1
8 secondary outcomes
POP-Q (Pelvic organ Quantification System)
Time frame: 6 months after intervention (operation or start of pelvic floor training)
Ultrasound of perineum
Time frame: 6 months after intervention (operation or start of pelvic floor training)
Pelvic floor distress inventory (PFDI 20)
Time frame: 6 months after intervention (operation or start of pelvic floor training)
Pelvic Floor Impact Questionnaire (PIFQ-7)
Time frame: 6 months after intervention (operation or start of pelvic floor training)
Prolapse Incontinence Sexual Questionnaire (PISQ)
Time frame: 6 months after intervention (operation or start of pelvic floor training)
Hospital Anxiety and Depression Scale (HAD)
Time frame: 6 months after intervention (operation or start of pelvic floor training)
Vaginal symptoms
Time frame: 6 months after intervention (operation or start of pelvic floor training)
Surgical complications
Time frame: From surgery up to 6 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Background: PubMed 12203375Woodman 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. doi: 10.1002/ca.10034.
- Results publication: PubMed 12806450Harvey 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. doi: 10.1016/s1701-2163(16)30310-3.
- Derived from this study: PubMed 31923073Bergman I, Westergren Soderberg M, Ek M. Perineorrhaphy Compared With Pelvic Floor Muscle Therapy in Women With Late Consequences of a Poorly Healed Second-Degree Perineal Tear: A Randomized Controlled Trial. Obstet Gynecol. 2020 Feb;135(2):341-351. doi: 10.1097/AOG.0000000000003653.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Ek, M.D., Ph.D. principal investigator
Stockholm South General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineorraphy and Pelvic floor exercise in people with Perineal Tear Resulting From Childbirth, run by Stockholm South General Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Global Impression of Improvement (PGI-1) (time frame: 6 months after intervention (operation or start of pelvic floor training)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02545218, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.