Kari Nieminen

Low-weight polypropylene mesh for anterior vaginal wall prolapse: a randomized controlled trial.

OBJECTIVE: To compare anterior colporrhaphy with and without a tailored mesh. METHODS: Postmenopausal women with anterior vaginal prolapse to the hymen or beyond were randomly assigned to undergo traditional anterior colporrhaphy alone or reinforced with mesh. The low-weight monofilament polypropylene mesh was self-tailored, having four arms and being placed over the plicated fascia. Before and 2 and 12 months after surgery, participants were evaluated by physical examination, postvoidal residual urine measurement and standard questions covering prolapse-related symptoms. The primary outcome was recurrence of anterior vaginal prolapse at 12 months. Secondary outcomes included operative complications, symptom resolution, and postvoidal urine residual volume. RESULTS: Of the 202 women randomly assigned, 201 were operated on (97 without, 104 with mesh). Thirty-seven women (38.5%) in the no-mesh and seven (6.7%) in the mesh group experienced a recurrence of anterior wall prolapse (P<.001) at 12 months; as a result, the number needed to treat for benefit was four. The mean (standard deviation) postvoidal residual urine volume was lower in patients with mesh than in those undergoing the traditional operation: 25 (26) mL and 41 (57) mL (P=.01). Twenty-three women (23%) with mesh and 9 (10%) with no mesh reported stress urinary incontinence (P=.02). In 18 (17.3%), exposure of the mesh was noted, mainly asymptomatic. CONCLUSION: Anterior colporrhaphy, reinforced with, tailored mesh significantly reduced the rate of recurrence of anterior vaginal wall prolapse compared with the traditional operation, but was associated more often with stress urinary incontinence. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00420225 LEVEL OF EVIDENCE: I

Outcomes after anterior vaginal wall repair with mesh: a randomized, controlled trial with a 3 year follow-up

OBJECTIVE The objective of the study was to compare anterior colporrhaphy with and without a mesh. STUDY DESIGN Two hundred two women with anterior prolapse were assigned to undergo colporrhaphy alone or reinforced with a tailored polypropylene mesh. Before and 2, 12, 24, and 36 months after surgery, the outcome was assessed by examination and standard questions. The primary endpoint was anatomic recurrence of anterior vaginal prolapse. Secondary outcomes were symptom resolution, reoperation, and mesh exposure. RESULTS Recurrences of anterior vaginal prolapse were noted in 40 of the 97 (41%) in the colporrhaphy group and 14 of 105 (13%) in the mesh group (P < .0001). The number needed to treat was thus 4. The proportion of symptomatic patients, including those with dyspareunia, did not differ between the groups. The mesh erosion rate was 19%. CONCLUSION At 3 year follow-up, anterior colporrhaphy with mesh reinforcement significantly reduced anatomic recurrences of anterior vaginal prolapse, but no difference in symptomatic recurrence were noted and the mesh erosion rate was high. The use of mesh was not associated with an increase in dyspareunia.

Transanal or Vaginal Approach to Rectocele Repair: A Prospective, Randomized Pilot Study

PURPOSEThis study was designed to compare outcomes of transanal and vaginal techniques for rectocele repair.METHODSThirty females with symptomatic rectocele were enrolled in a prospective, randomized study. Fifteen underwent transanal rectoceleplasty, the other 15 underwent vaginal posterior colporrhaphy. Patients were assessed by clinical interview and examination, defecography, colon transit study, and anorectal manometry before randomization and 12 months postoperatively. Patients with compromised anal sphincter function or other symptomatic prolapse were excluded.RESULTSThe study groups were comparable in terms of demographic factors and rectocele-related symptoms and signs. Eleven (73 percent) patients in the vaginal group and 10 (66 percent) in the transanal group digitally assisted rectal emptying preoperatively. The mean depth of the rectocele was 6.0 ± 1.6 cm vs. 5.6 ± 1.8 cm (P = 0.53) in the respective groups. At follow-up, 14 (93 percent) patients in the vaginal group and 11 (73 percent) in the transanal group reported improvement in symptoms (P = 0.08). Need to digitally assist rectal emptying decreased significantly in both groups, to one (7 percent) for the vaginal group and four (27 percent) for the transanal group (P = 0.17 between groups). The respective recurrence rates of rectocele were one (7 percent) vs. six (40 percent) (P = 0.04), and enterocele rates were zero vs. four (P = 0.05). In the vaginal group defecography showed a significant decrease in rectocele depth whereas in the transanal group the difference did not reach statistical significance. None of the patients reported de novo dyspareunia, but 27 percent reported improvement.CONCLUSIONPatients’ symptoms were significantly alleviated by both operative techniques. The transanal technique was associated with more clinically diagnosed recurrences of rectocele and/or enterocele. Adverse effects on sexual life were avoided by use of both techniques.

Anatomic and functional assessment and risk factors of recurrent prolapse after vaginal sacrospinous fixation

Background.  To identify risk factors in recurrence and to evaluate anatomic and functional results of vaginal sacrospinous ligament fixation and pelvic floor reconstruction for genital prolapse.

Sacrospinous ligament fixation for massive genital prolapse in women aged over 80 years

Objective To assess the feasibility of vaginal sacrospinous ligament fixation for women over 80 years of age with massive vaginal vault or uterovaginal prolapse.

Autologous Adipose Stem Cells in Treatment of Female Stress Urinary Incontinence: Results of a Pilot Study

The purpose of our study was to find out whether transurethral injections of autologous adipose stem cells (ASCs) are an effective and a safe treatment for female stress urinary incontinence (SUI). We treated five SUI patients with ASCs combined with bovine collagen gel and saline. Prior to the treatment, the ASCs were isolated from subcutaneous fat and expanded for 3 weeks in a good manufacturing practice‐level laboratory. The mixture of ASCs and collagen was injected transurethrally via cystoscope. Additionally, viability, multipotency, and surface marker profile of ASCs were analyzed in vitro. We followed up with patients 3, 6, and 12 months after the injections. The primary endpoint was a cough test to measure objectively the effect of the treatment. Validated questionnaires were used to determine the subjective cure rate. After 6 months, 1 of 5 patients displayed a negative cough test with full bladder filled with 500 ml of saline. At 1 year, the cough test was negative with three patients; two of them were satisfied with the treatment and did not wish further treatment for SUI. Validated questionnaires showed some subjective improvement in all five patients. This is the first study describing the use of autologous ASCs in combination with collagen gel for female SUI treatments. Thus far, the treatment with autologous ASCs has proven safe and well tolerated. However, the feasibility and efficacy of the treatment were not optimal; therefore, additional research is needed to develop SUI injection therapies.

Effective obstetric paracervical block with reduced dose of bupivacaine. A prospective randomized double-blind study comparing 25 mg (0.25%) and 12.5 mg (0.125%) of bupivacaine.

Background. To study whether paracervical block (PCB) with 12.5 mg (0.125 %) of bupivacaine is as effective as with 25 mg (0.25 %) and if there are differences in fetal heart rate (FMR) patterns between the doses.

Implementing robotic surgery to gynecologic oncology: the first 300 operations performed at a tertiary hospital

To investigate the initial experience with robotic‐assisted laparoscopic surgery in gynecologic oncology.

Combined anterior vaginal wall mesh with sacrospinous ligament fixation or with posterior intravaginal slingplasty for uterovaginal or vaginal vault prolapse

OBJECTIVE To evaluate outcomes of anterior vaginal wall mesh augmentation with concomitant sacrospinous ligament fixation (SSLF) or with concomitant posterior intravaginal slingplasty (IVS) for uterovaginal or vaginal vault prolapse. STUDY DESIGN Women with symptomatic uterovaginal or vaginal vault prolapse were randomly allocated to SSLF or IVS. All underwent concomitant anterior repair augmented with self-tailored multifilament polypropylene and polyglactin composite mesh. Before and 2, 12, 24 and 36 months after surgery, the outcome was assessed by examination and standard questions. The primary endpoint was anatomic recurrence of pelvic organ prolapse at stage II or beyond (-1 cm or greater) at any site of the vaginal wall. Secondary outcomes included perioperative and postoperative complications, symptom resolution, reoperation and mesh exposure. RESULTS Twenty-two women were recruited from March 2003 to December 2005. At 3-year follow-up3 (2 posterior and 1 apical) out of 14 (21%) in the IVS group had anatomic recurrences of pelvic organ prolapse, and 1 anterior out of 8 (13%) in the SSLF group. Severe operative complications or reoperations did not occur. The proportions of symptomatic patients, including those with dyspareunia, did not differ between the groups. Erosion of the anterior multifilament mesh was found in 2 out of 22 cases (9%; 95% CI 3-28%). CONCLUSION At 3-year follow-up anterior repair reinforced with a composite mesh with concomitant sacrospinous ligament fixation or with concomitant posterior intravaginal slingplasty allowed feasible support in patients with severe pelvic organ prolapse.

Functional Outcome of Human Adipose Stem Cell Injections in Rat Anal Sphincter Acute Injury Model

Anal incontinence is a devastating condition that significantly reduces the quality of life. Our aim was to evaluate the effect of human adipose stem cell (hASC) injections in a rat model for anal sphincter injury, which is the main cause of anal incontinence in humans. Furthermore, we tested if the efficacy of hASCs could be improved by combining them with polyacrylamide hydrogel carrier, Bulkamid. Human ASCs derived from a female donor were culture expanded in DMEM/F12 supplemented with human platelet lysate. Female virgin Sprague‐Dawley rats were randomized into four groups (n = 14–15/group): hASCs in saline or Bulkamid (3 × 105/60 μl) and saline or Bulkamid without cells. Anorectal manometry (ARM) was performed before anal sphincter injury, at two (n = 58) and at four weeks after (n = 33). Additionally, the anal sphincter tissue was examined by micro‐computed tomography (μCT) and the histological parameters were compared between the groups. The median resting and peak pressure during spontaneous contraction measured by ARM were significantly higher in hASC treatment groups compared with the control groups without hASCs. There was no statistical difference in functional results between the hASC‐carrier groups (saline vs. Bulkamid). No difference was detected in the sphincter muscle continuation between the groups in the histology and μCT analysis. More inflammation was discovered in the group receiving saline with hASC. The hASC injection therapy with both saline and Bulkamid is a promising nonsurgical treatment for acute anal sphincter injury. Traditional histology combined with the 3D μCT image data lends greater confidence in assessing muscle healing and continuity. Stem Cells Translational Medicine 2018;7:295–304