Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perineorraphy | Procedure | Surgery for improperly healed perineal tear |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Ultrasound of perineum |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marion Ek, M.D., Ph.D. | Stockholm South General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södersjukhuset | Stockholm | 11861 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12203375 | Background | 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. | |
| 12806450 | Result | 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. doi: 10.1016/s1701-2163(16)30310-3. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pelvic floor exercise |
| Other |
Pelvic floor exercise tutored by physio therapist. |
|
Height and depth of perineum i millimeters using ultrasonography |
| 6 months after intervention (operation or start of pelvic floor training) |
| Pelvic floor distress inventory (PFDI 20) | 20 validated questions concerning prolapse related symptoms | 6 months after intervention (operation or start of pelvic floor training) |
| Pelvic Floor Impact Questionnaire (PIFQ-7) | Evaluates the effect on quality of lafe. | 6 months after intervention (operation or start of pelvic floor training) |
| Prolapse Incontinence Sexual Questionnaire (PISQ) | Evaluate effects on sexual functions | 6 months after intervention (operation or start of pelvic floor training) |
| Hospital Anxiety and Depression Scale (HAD) | Evaluate psychological effects | 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. | 6 months after intervention (operation or start of pelvic floor training) |
| Surgical complications | Infections.Bleedings. Other complications. | From surgery up to 6 months postoperatively |
| 31923073 | Derived | Bergman 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. |