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Native-tissue pelvic organ prolapse (POP) repair with perineorrhaphy for level III support results in reduced genital hiatus size and improved quality of life in sexually active and inactive patients

  • Anke R. Mothes
    Affiliations
    Department of Gynaecology and Reproductive Medicine, Jena University Hospital, Friedrich-Schiller-University Jena, Am Klinikum 1, 07747 Jena, Germany

    Department of Gynaecology, St. Georg Hospital Eisenach, Academic Teaching Hospital of Friedrich-Schiller-University Jena, Eisenach, Germany
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  • Isabel Raguse
    Affiliations
    Department of Gynaecology and Reproductive Medicine, Jena University Hospital, Friedrich-Schiller-University Jena, Am Klinikum 1, 07747 Jena, Germany

    Department of Traumatology, Hand and Reconstructive Surgery, Jena University Hospital, Friedrich-Schiller-University Jena, Am Klinikum 1, 07747 Jena, Germany
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  • Angela Kather
    Affiliations
    Department of Gynaecology and Reproductive Medicine, Jena University Hospital, Friedrich-Schiller-University Jena, Am Klinikum 1, 07747 Jena, Germany
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  • Ingo B. Runnebaum
    Correspondence
    Corresponding author at: Department of Gynaecology and Reproductive Medicine, Jena University Hospital, Friedrich-Schiller-University Jena, Am Klinikum 1, 07747 Jena, Germany.
    Affiliations
    Department of Gynaecology and Reproductive Medicine, Jena University Hospital, Friedrich-Schiller-University Jena, Am Klinikum 1, 07747 Jena, Germany
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Open AccessPublished:November 23, 2022DOI:https://doi.org/10.1016/j.ejogrb.2022.11.023

      Abstract

      Introduction and hypothesis

      Recent findings address the importance of Level III defects with increased genital hiatus being associated with pelvic organ prolapse (POP), correlated with Level I defects and strongly related to POP recurrence. We hypothesised that concomitant perineorrhaphy in POP repair reduces genital hiatus (gh) and increases perineal body (pb), that gh would be larger with number of vaginal deliveries and that patients’ QOL was not different comparing sexually active vs inactive patients with overall judgement of cure comparable to the literature at evaluation.

      Methods

      Retrospective observational study including consecutive patients with indications for posterior repair and Level III support between 2016 and 2018. Concomitant perineorrhaphy was indicated due to complaints of wide introitus or genital hiatus of ≥ 3.5 cm. Primary objective was to compare pre- and postoperative gh and pb according to POP-Q. Secondary objectives were preoperative gh and pb values by parity, POMs obtained with P-QOL/D comparing sexually active vs inactive patients, and subjective judgement of cure according to EGGS system.

      Results

      In n = 121 patients, mean gh value was reduced postoperatively by 29.5 % (31 ± 6 vs 44 ± 10 mm, p < 0.001), mean pb value increased by 25.5 % (47 ± 8 vs 35 ± 8 mm, p < 0.001). Influence of parity on preoperative gh (p = 0.020), but not pb values (p = 0.119) was observed. All P-QOL/D domain scores improved significantly postoperatively without differences seen in sexually active vs inactive patients. EGGS responses indicated partial/full goal achievement in 90 % and cure in 87 %.

      Conclusions

      In the study cohort, perineorrhaphy as concomitant in POP repair led to Level III support reflected by decreased genital hiatus size. Functional QOL was improved regardless of sexual activity status and the majority of patients reported partial or full cure.

      Keywords

      Summary

      We observed 29.5 % reduction of genital hiatus and 25.5 % increase of perineal body after defect specific native tissue POP repair with perineorrhaphy for Level III support as a concomitant procedure. Additionally, influence of parity on Level III support mirrored by preoperative gh values (p = 0.020), but not on preoperative pb values (p = 0.119) was found. Preoperative gh values were higher after four vaginal deliveries compared with primiparous patients (p = 0.034) and compared to patients after two vaginal deliveries (p = 0.047). Within the evaluation interval, we observed reduction of all prolapse symptoms reflected by improved P-QOL/D scores in all domains regardless of patients’ sexual activity status, 87 % of patients felt partially or fully cured and would recommend such surgery to friends with same complaints. Our findings contribute to the discussion on perineorrhaphy for Level III defect repair as an important part of defect specific native tissue POP surgery.

      Introduction

      In the context of defect specific reconstructive surgery and the search for risk factors related to prolapse recurrence after native tissue repair, surgical anatomy of vagina and vaginal introitus has been further described. [

      Haylen BT, Vu D, Wong A, Livingstone S. Surgical anatomy of the mid-vagina. Neurourol Urodyn. 2022 Jun 22. doi: 10.1002/nau.24994. Epub ahead of print.

      ,

      Haylen BT, Vu D, Wong A. Surgical anatomy of the vaginal introitus. Neurourol Urodyn. 2022 May 20. doi: 10.1002/nau.24961. Epub ahead of print.

      ,
      • Schmidt P.
      • Chen L.
      • DeLancey J.O.
      • Swenson C.W.
      Preoperative level II/III MRI measures predicting long-term prolapse recurrence after native tissue repair.
      ,
      • Cheng W.
      • Thibault M.D.
      • Chen L.
      • DeLancey J.O.L.
      • Swenson C.W.
      Changes in cardinal ligament length and curvature with parity and prolapse and their relation to level III hiatus measures.
      ] Recent findings suggest that Level III defects [
      • DeLancey J.O.L.
      Anatomical aspects of vaginal eversion after hysterectomy.
      ,
      • Haylen B.T.
      • Maher C.F.
      • Barber M.D.
      • Camargo S.
      • Dandolu V.
      • Digesu A.
      • et al.
      An international urogynecological association (IUGA)/international continence society (ICS) joint report on the terminology for female pelvic organ prolapse (POP).
      ] mainly reflected by an increased genital hiatus size are strongly associated with prolapse development [
      • Handa V.L.
      • Blomquist J.L.
      • Carroll M.
      • Roem J.
      • Muñoz A.
      Longitudinal changes in the genital hiatus preceding the development of pelvic organ prolapse.
      ,
      • Handa V.L.
      • Blomquist J.L.
      • Carroll M.K.
      • Muñoz A.
      Genital Hiatus Size and the development of prolapse among parous women.
      ] and correlate with Level I defects [
      • Cheng W.
      • Thibault M.D.
      • Chen L.
      • DeLancey J.O.L.
      • Swenson C.W.
      Changes in cardinal ligament length and curvature with parity and prolapse and their relation to level III hiatus measures.
      ]. Furthermore, increased genital hiatus was related to risk for multi-compartment prolapse recurrence [
      • Schmidt P.
      • Chen L.
      • DeLancey J.O.
      • Swenson C.W.
      Preoperative level II/III MRI measures predicting long-term prolapse recurrence after native tissue repair.
      ,
      • Vaughan M.H.
      • Siddiqui N.Y.
      • Newcomb L.K.
      • Weidner A.C.
      • Kawasaki A.
      • Visco A.G.
      • et al.
      Surgical alteration of genital hiatus size and anatomic failure after vaginal vault suspension.
      ,
      • Bradley M.S.
      • Askew A.L.
      • Vaughan M.H.
      • Kawasaki A.
      • Visco A.G.
      Robotic-assisted sacrocolpopexy: early postoperative outcomes after surgical reduction of enlarged genital hiatus.
      ]. Therefore, and with regard to a revised interpretation of surgical anatomy [

      Haylen BT, Vu D, Wong A, Livingstone S. Surgical anatomy of the mid-vagina. Neurourol Urodyn. 2022 Jun 22. doi: 10.1002/nau.24994. Epub ahead of print.

      ,

      Haylen BT, Vu D, Wong A. Surgical anatomy of the vaginal introitus. Neurourol Urodyn. 2022 May 20. doi: 10.1002/nau.24961. Epub ahead of print.

      ] including MRI studies, [
      • Schmidt P.
      • Chen L.
      • DeLancey J.O.
      • Swenson C.W.
      Preoperative level II/III MRI measures predicting long-term prolapse recurrence after native tissue repair.
      ,
      • Cheng W.
      • Thibault M.D.
      • Chen L.
      • DeLancey J.O.L.
      • Swenson C.W.
      Changes in cardinal ligament length and curvature with parity and prolapse and their relation to level III hiatus measures.
      ,

      Chen L, Lisse S, Larson K, Berger MB, Ashton-Miller JA, DeLancey JOL. Structural Failure Sites in Anterior Vaginal Wall Prolapse: Identification of a Collinear Triad. Obstet Gynecol. 2016 Oct;128(4):853-862. Erratum in: Obstet Gynecol. 2017 Jan;129(1):209-210.

      ] perineorrhaphy as an easy to perform surgical step for Level III support seems to have reached growing importance in pelvic floor reconstructive surgery.
      In this study, we investigated the effect of defect specific pelvic organ prolapse (POP) surgery involving perineorrhaphy for Level III repair with reconstruction of enlarged genital hiatus. As primary objective, we evaluated gh and pb measurements according to POP-Q and compared pre- and postoperative values. We hypothesised that after reconstructive surgery including perineorrhaphy for clinical Level III defects performed in the manner described, genital hiatus (gh) would be reduced and perineal body (pb) would be increased compared to preoperative measures.
      As genital hiatus size is considered an important marker for pelvic muscle damage [
      • Dunivan G.C.
      • Lyons K.E.
      • Jeppson P.C.
      • Ninivaggio C.S.
      • Komesu Y.M.
      • Alba F.M.
      • et al.
      Pelvic organ prolapse stage and the relationship to genital hiatus and perineal body measurements.
      ] mainly related to obstetric history, we examined preoperative gh and pb values by parity as secondary objective.
      In our clinical experience and as reported in the literature, patients with Level III defects presenting an enlarged genital hiatus complain of discomfort and the feeling that vulva or vaginal outlet is wide and relaxed [
      • Ulubay M.
      • Keskin U.
      • Fidan U.
      • et al.
      Safety, efficiency, and outcomes of perineorrhaphy: treatment of the sensation of a wide vagina.
      ,
      • Pardo J.
      • Solà V.
      • Ricci P.
      • Guiloff E.
      • Freundlich O.
      Colpoperineoplasty in women with a sensation of a wide vagina.
      ,
      • Nichols D.H.
      Enterocele and massive eversion of the vagina.
      ]. Urogynaecologists debate on clinical benefit or harm of concomitant perineorrhaphy in POP procedures with regard to pain and dyspareunia as possible side effects of scars and narrowing [
      • Ulubay M.
      • Keskin U.
      • Fidan U.
      • et al.
      Safety, efficiency, and outcomes of perineorrhaphy: treatment of the sensation of a wide vagina.
      ,
      • Francis W.J.
      • Jeffcoate T.N.
      Dyspareunia following vaginal operations.
      ,
      • Woodward A.P.
      • Matthews C.A.
      Outcomes of revision perineoplasty for persistent postpartum dyspareunia.
      ,
      • Jeffcoate T.
      Posterior colpoperineorrhaphy.
      ,
      • Abedi P.
      • Jamali S.
      • Tadayon M.
      • Parhizkar M.
      • Mogharab F.
      Effectiveness of selective vaginal tightening on sexual function among reproductive aged women in Iran with vaginal laxity: a quasi-experimental study.
      ]. However, limited data are available on functional outcome and patient́ś perception of a post-surgical decrease in genital hiatus width so far. Therefore, we evaluated patient related outcomes in the three dimensions of cure: objective anatomical and functional cure, and patients’ subjective judgement. Additional secondary outcome measures were POMs obtained with the prolapse quality-of-life questionnaire (P-QOL/D, German version) [
      • Digesu G.A.
      • Khullar V.
      • Cardozo L.
      • Robinson D.
      • Salvatore S.
      P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse.
      ,
      • Lenz F.
      • Stammer H.
      • Brocker K.
      • Rak M.
      • Scherg H.
      • Sohn C.
      Validation of a German version of the P-QOL Questionnaire.
      ] comparing sexually active and inactive patients and the expectations, goal setting, goal achievement and satisfaction (EGGS) system [
      • Mothes A.R.
      • Wanzke L.
      • Radosa M.P.
      • Runnebaum I.B.
      Bilateral minimal tension sacrospinous fixation in pelvic organ prolapse: an observational study.
      ,
      • Brubaker L.
      • Shull B.
      EGGS for patient-centered outcomes.
      ]. It was hypothesized that patients’ QOL after such surgery resulting in reduced genital hiatus was not different comparing sexually active vs inactive patients and the overall judgement of cure was comparable to the literature.

      Materials and methods

      • Sample and surgery
      This retrospective observational study was conducted with data from consecutive patients who underwent defect-specific native tissue vaginal pelvic-floor reconstructive surgery with perineorrhaphy for symptomatic POP presenting indications for posterior repair and Level III support defects at the Jena University Pelvic Floor Centre, between 2016 and 2018. Perineorrhaphy was indicated due to patientś complaints of a wide introitus or intra-operatively according to the finding of an enlarged genital hiatus. The former was defined as >3.5 cm being taken with a ruler, the equivalent of two fingers on intra-operative examination [

      Haylen BT, Vu D, Wong A, Livingstone S. Surgical anatomy of the mid-vagina. Neurourol Urodyn. 2022 Jun 22. doi: 10.1002/nau.24994. Epub ahead of print.

      ].
      Informed consent was given by all patients prior to surgery and questionnaire survey as well as in the context of data use. The study was designed and performed in accordance with the relevant guidelines and regulations and the proposal was covered by the research approval for data use and clinical studies of the General Ethics Commission, Faculty of Medicine, Jena University Hospital, Germany (No. 4224–09/14). Ethical approval was granted on the 6th of January 2015.
      The modified surgical method for perineorrhaphy performed at the Jena surgical school consists of the following steps [
      • Nichols D.H.
      Enterocele and massive eversion of the vagina.
      ,
      • Martius G.
      Operationen zur Behandlung des Deszensus genitalis und der Stressinkontinenz.
      ,
      • Kyank H.
      Vaginale Operationen und Eingriffe am äußeren Genitale.
      ]. A transverse incision is made at the musculocutaneous border of the posterior hymen, depending on the size of the vaginal outlet. A triangular posterior epithelial flap is then removed. The procedure is usually combined with recto- and enterocele or other compartment repairs depending on individual defect patterns. Depending on intra-operative findings, tissues proximal and distal of the hymen are included. Proximal of the hymen, the perirectal connective fascia tissue is approximated over the distal part of the rectocele using one to three deep interrupted sutures depending on the size of the vaginal outlet and extent of the posterior compartment defect. No levator plication is performed. Where the bulbocavernosus muscles deviate, they are re-approximated with one or two sutures; in most cases, it might be appropriate to re-approximate transverse perineal muscles in addition. The skin is then trimmed and closed (Fig. 1 a-f). Technically, we have found that the avoidance of tissue bridges and steps potentially leading to dyspareunia is especially important. Therefore, the posterior hymenal edge should emerge at a level similar to that of the posterior vaginal wall at the end of the operation to prevent dyspareunia and tightness [
      • Abedi P.
      • Jamali S.
      • Tadayon M.
      • Parhizkar M.
      • Mogharab F.
      Effectiveness of selective vaginal tightening on sexual function among reproductive aged women in Iran with vaginal laxity: a quasi-experimental study.
      ,
      • Weber A.
      • Walters M.
      • Piedmonte M.
      Sexual function and vaginal anatomy in women before and after surgery for pelvic organ prolapse and urinary incontinence.
      ]. In the Jena Universitýs vaginal surgical school, single stiches are performed for all sutures in every layer of pelvic floor repairs. PDSTM 2–0 SH (Ethicon Inc., Somerville, NJ, USA) sutures are used for fascial repair, PDSTM 2–0 SH-1 (Ethicon Inc., Somerville, NJ, USA) sutures for enterocele repair, Serafit© 2/0 HRT-26 (SERAG WIESSNER, Naila, Germany) for sacrospinous fixations and VicrylTM 3–0 (Ethicon Inc., Somerville, NJ, USA) for skin closure.
      • Data collection and evaluations
      Figure thumbnail gr1
      Fig. 1Typically wide introitus in POP prior to surgery (a), surgical reconstruction of anterior (b), posterior compartment (c, d), perineorrhaphy (e), result (f).
      Data on patients’ baseline characteristics and prolapse disease (age, body mass index, parity, symptoms, prolapse stage, sexual activity) were extracted from computer- and paper-based hospital files. Gh and pb measurements were extracted from surgical reports. POP-Q [
      • Bump R.C.
      • Mattiasson A.
      • Bo K.
      • et al.
      The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction.
      ] measurements were performed with the patient under anaesthesia in lithotomy position on the operation table at beginning and end of surgery. Gh was measured from the middle of the external urethral meatus to the posterior aspect of the hymen. [
      • Haylen B.T.
      • Maher C.F.
      • Barber M.D.
      • Camargo S.
      • Dandolu V.
      • Digesu A.
      • et al.
      An international urogynecological association (IUGA)/international continence society (ICS) joint report on the terminology for female pelvic organ prolapse (POP).
      ] Pb was measured from the posterior margin of hymen to the mid-anal opening. [
      • Haylen B.T.
      • Maher C.F.
      • Barber M.D.
      • Camargo S.
      • Dandolu V.
      • Digesu A.
      • et al.
      An international urogynecological association (IUGA)/international continence society (ICS) joint report on the terminology for female pelvic organ prolapse (POP).
      ,
      • Dunivan G.C.
      • Lyons K.E.
      • Jeppson P.C.
      • Ninivaggio C.S.
      • Komesu Y.M.
      • Alba F.M.
      • et al.
      Pelvic organ prolapse stage and the relationship to genital hiatus and perineal body measurements.
      ]
      For the assessment of patients’ QOL before and after surgery, the validated German version of the P-QOL/D [
      • Digesu G.A.
      • Khullar V.
      • Cardozo L.
      • Robinson D.
      • Salvatore S.
      P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse.
      ,
      • Lenz F.
      • Stammer H.
      • Brocker K.
      • Rak M.
      • Scherg H.
      • Sohn C.
      Validation of a German version of the P-QOL Questionnaire.
      ] was used with better quality of life indicated by lower score. This questionnaire consists of nine domains (general health perceptions, prolapse impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy and severity measures) and has been used for evaluation of prolapse surgery outcomes before [
      • Mothes A.R.
      • Wanzke L.
      • Radosa M.P.
      • Runnebaum I.B.
      Bilateral minimal tension sacrospinous fixation in pelvic organ prolapse: an observational study.
      ]. To obtain patient-centred outcomes, patients’ subjective judgement of surgical success and cure was assessed using the EGGS system [
      • Brubaker L.
      • Shull B.
      EGGS for patient-centered outcomes.
      ] after surgery, as used for evaluation of surgical success in POP before [
      • Mothes A.R.
      • Wanzke L.
      • Radosa M.P.
      • Runnebaum I.B.
      Bilateral minimal tension sacrospinous fixation in pelvic organ prolapse: an observational study.
      ,
      • Brubaker L.
      • Shull B.
      EGGS for patient-centered outcomes.
      ]. The following questions were posed to the patients: What results did you expect from surgery? Were your expectations influenced by information given to you by friends or family members having the same symptoms, by your physician, or by television, internet, or newspaper? Were your expectations fulfilled (yes/partially/no)? Do you have residual symptoms such as dysuria, urgency, urinary incontinence, vaginal discomfort, and/ or difficulty in emptying your bladder (yes/no)? Can you accept the residual symptoms you are experiencing (yes/partially/no)? Do you feel cured (yes/partially/no)? Would you recommend the operation to a close friend having the same symptoms you had before surgery (yes/no)? [
      • Mothes A.R.
      • Wanzke L.
      • Radosa M.P.
      • Runnebaum I.B.
      Bilateral minimal tension sacrospinous fixation in pelvic organ prolapse: an observational study.
      ]
      • Statistical analysis
      Data were analysed using the Statistical Package for the Social Sciences (version 15.0; SPSS Inc., Chicago, IL, USA). Due to presence of outliers and rather small numbers of patients in compared groups, preconditions for use of parametric tests were not satisfied. This was confirmed by tests for normal distribution of data. Therefore, non-parametric tests (Mann–Whitney U test and Wilcoxon test, respectively) were used as indicated. Preoperative gh and pb values of primiparous patients and patients who had experienced two, three or four vaginal deliveries were compared with the Kruskal-Wallis test.
      Statistical analysis of P-QOL/D questionnaire data was performed according to Lenz et al. 2009 [
      • Lenz F.
      • Stammer H.
      • Brocker K.
      • Rak M.
      • Scherg H.
      • Sohn C.
      Validation of a German version of the P-QOL Questionnaire.
      ]. Preoperative vs postoperative P-QOL/D scores were compared using Wilcoxon tests for all patients and subgroups of sexually active and inactive patients. Data from patients with and without histories of sexual activity were compared performing Mann–Whitney U test.

      Results

      The study cohort consisted of 121 consecutive patients meeting the inclusion criteria with a mean age of 67 ± 10 (range, 47–91) years; 45 % of these patients were sexually active. Gh and pb measurements were available for all patients. The P-QOL and EGGS return rate was 53 % (n = 64); 50 % (n = 32) of patients who returned questionnaires were sexually active.
      Patients’ baseline characteristics are summarised in Table 1. All but one patient had undergone at least one vaginal delivery. Information on parity was not available for one patient. Most (74 %) patients had stage II–III prolapse; the remaining patients had stage IV prolapse. All patients presented with typical POP symptoms; the majority (94 %) reported vaginal discomfort or common bladder symptoms [i.e. urgency, stress urinary incontinence (SUI) and voiding difficulties].
      Table 1Baseline patient characteristics and concomitant procedures (n = 121).
      VariableMean ± SD (range) or n (%)
      Age (years)67 ± 10 (47–91)
      Body mass index (kg/m2)27 ± 4 (18–48)
      Parity2 ± 0.7 (1–4)
      Sexually active54 (45)
      Main symptoms
      Feeling of prolapse70 (58)
      Urgency22 (18)
      SUI11 (9)
      Voiding difficulties7 (6)
      Pain3 (3)
      Other7 (6)
      Prolapse stage
      II–III89 (74)
      IV32 (26)
      Concomitant procedures
      Hysterectomy66 (54)
      Anterior repair111 (91)
      Posterior repair118 (97)
      Level I repair115 (95)
      SD, standard deviation; SUI, stress urinary incontinence.
      Postoperatively, mean gh values were reduced by 29.5 % (31 ± 6 mm versus 44 ± 10 mm, p < 0.001), while pb values were increased by 25.5 % (47 ± 8 mm versus 35 ± 8 mm, p < 0.001; Wilcoxon test).
      Preoperatively, we observed increasing gh and declining pb values with increasing number of vaginal deliveries (Table 2). Using the Kruskal-Wallis test, our data show an influence of parity on preoperative gh values (p = 0.020), but not on preoperative pb values (p = 0.119). Post-hoc analysis revealed significantly higher preoperative gh values in patients who had experienced four vaginal deliveries compared with those of primiparous patients (p = 0.034) and patients who had experienced two vaginal deliveries (p = 0.047).
      Table 2Preoperative POP-Q gh and pb values by parity (in one patient, parity not known; n = 120).
      POP-Q variableParitypa
      I (n = 27)II (n = 63)III (n = 27)IV (n = 3)
      gh (mm)42 ± 943 ± 847 ± 1259 ± 70.020
      pb0.034c0.047d
      pb (mm)38 ± 835 ± 933 ± 832 ± 90.119
      Values are means ± standard deviations. aKruskal-Wallis test. bPost-hoc test. cGroup 1 compared to group 4. dGroup 2 compared to group 4. P-value for all other pairwise comparisons was > 0.05. POP-Q, pelvic organ prolapse quantification system; gh, genital hiatus; pb, perineal body.
      Mean evaluation interval concerning P-QOL and EGGS questionnaires was 15.8 (SD 5.2) months. Compared to baseline, all nine P-QOL/D domains had improved postoperatively in the total cohort and in the sexually active and inactive subgroups (Table 3). Only the postoperative prolapse impact score differed between sexually active and inactive patients (p = 0.016); it was lower in the former group (Table 3).
      Table 3P-QOL/D scores (all patients, n = 64; sexually active and inactive patients, n = 32 each).
      DomainGroupPreoperativePostoperativepa
      General health perceptionsAll58.6 ± 25.727.7 ± 17.3<0.001
      Active53.9 ± 23.925.0 ± 14.1<0.001
      Inactive63.3 ± 26.930.5 ± 19.8<0.001
      Prolapse impactAll78.1 ± 28.032.8 ± 26.9<0.001
      Active77.1 ± 24.625.0 ± 23.9b<0.001
      Inactive79.1 ± 31.440.6 ± 27.7<0.001
      Role limitationsAll63.3 ± 29.323.7 ± 27.8<0.001
      Active63.5 ± 23.719.3 ± 26.5<0.001
      Inactive63.0 ± 34.328.1 ± 28.8<0.001
      Physical limitationsAll59.4 ± 31.524.6 ± 29.6<0.001
      Active58.3 ± 24.719.8 ± 27.6<0.001
      Inactive60.4 ± 37.629.6 ± 31.2<0.001
      Social limitationsAll31.6 ± 33.211.5 ± 22.2<0.001
      Active20.4 ± 19.35.4 ± 13.10.002
      Inactive42.4 ± 40.117.6 ± 27.50.001
      Personal relationshipsAll56.1 ± 39.329.1 ± 33.8<0.001
      Active55.7 ± 37.628.0 ± 35.40.004
      Inactive56.5 ± 42.330.7 ± 32.00.002
      EmotionsAll45.7 ± 35.721.3 ± 29.8<0.001
      Active43.0 ± 31.517.0 ± 28.3<0.001
      Inactive48.3 ± 39.525.3 ± 31.1<0.001
      Sleep/energyAll37.0 ± 29.119.8 ± 24.5<0.001
      Active33.3 ± 26.216.7 ± 25.10.001
      Inactive40.6 ± 31.722.9 ± 23.90.007
      Severity measuresAll47.4 ± 23.922.2 ± 18.5<0.001
      Active47.7 ± 21.118.1 ± 15.4<0.001
      Inactive47.0 ± 26.726.1 ± 20.50.001
      Values are means ± standard deviations. aWilcoxon test, preoperative vs postoperative; bSexually active vs inactive, p = 0.016 (Mann–Whitney U test). P-QOL/D, prolapse quality-of-life questionnaire, German version.
      • Digesu G.A.
      • Khullar V.
      • Cardozo L.
      • Robinson D.
      • Salvatore S.
      P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse.
      ,
      • Lenz F.
      • Stammer H.
      • Brocker K.
      • Rak M.
      • Scherg H.
      • Sohn C.
      Validation of a German version of the P-QOL Questionnaire.
      A lower score indicates a better quality of life.
      EGGS responses indicated that patients expected absence of prolapse (n = 15/54; 28 %), general improvement of QOL (n = 14/54; 26 %), improvement of bladder dysfunction (n = 14/54; 26 %) and discomfort/pain reduction (n = 11/54; 20 %) relative to their preoperative situations. In 95 % (n = 59/62), patients’ expectations were influenced by their physicians. Other influencers were friends and family (n = 7/62; 11 %) and the media (n = 6/62; 9 %). Most (n = 54/60; 90 %) patients reported full or partial goal achievement; 45 % (n = 28/62) reported that they had no residual symptoms and 55 % (n = 34/62) reported residual symptoms such as SUI, urgency, residual volume and prolapse. Of the latter, eight patients found the residual symptoms to be unacceptable and sought further treatment, whereas 87 % (n = 55/63) felt fully or partially cured and would recommend the surgery to friends with the same problems.

      Discussion

      In this study on 121 cases with perineorrhaphy performed for Level III defect as a concomitant procedure in defect specific native tissue POP repair, we observed 29.5 % reduction of genital hiatus and 25.5 % increased perineal body, significantly changed relative to baseline (p < 0.001). Additionally, our data show an influence of parity on Level III support mirrored by preoperative gh values (p = 0.020), but not on preoperative pb values (p = 0.119). Preoperative gh values were higher after four vaginal deliveries compared to primiparous patients (p = 0.034) and compared to patients after two vaginal deliveries (p = 0.047). Within the evaluation interval, we observed reduction of prolapse symptoms reflected by improved P-QOL/D scores in all domains regardless of patients’ sexual activity status, 87 % of patients felt partially or fully cured and would recommend such surgery to friends with same complaints. Our findings contribute to the discussion on perineorrhaphy for Level III defects as an important part of defect specific native tissue POP surgery.

      Level III defects and perineorrhaphy

      Gh and pb contribute to the anatomical appearance of the external genitalia and level III pelvic floor support [

      Haylen BT, Vu D, Wong A. Surgical anatomy of the vaginal introitus. Neurourol Urodyn. 2022 May 20. doi: 10.1002/nau.24961. Epub ahead of print.

      ,
      • Schmidt P.
      • Chen L.
      • DeLancey J.O.
      • Swenson C.W.
      Preoperative level II/III MRI measures predicting long-term prolapse recurrence after native tissue repair.
      ,
      • Cheng W.
      • Thibault M.D.
      • Chen L.
      • DeLancey J.O.L.
      • Swenson C.W.
      Changes in cardinal ligament length and curvature with parity and prolapse and their relation to level III hiatus measures.
      ,
      • Handa V.L.
      • Blomquist J.L.
      • Carroll M.K.
      • Muñoz A.
      Genital Hiatus Size and the development of prolapse among parous women.
      ,
      • Dunivan G.C.
      • Lyons K.E.
      • Jeppson P.C.
      • Ninivaggio C.S.
      • Komesu Y.M.
      • Alba F.M.
      • et al.
      Pelvic organ prolapse stage and the relationship to genital hiatus and perineal body measurements.
      ,
      • DeLancey J.
      Structural anatomy of the posterior pelvic compartment as it relates to rectocele.
      ], and they have clinical implications. While low pb values indicated the risk of unsuccessful pessary treatment [
      • Vakili B.
      • Zheng Y.T.
      • Loesch H.
      • Echols K.T.
      • Franco N.
      • Chesson R.R.
      Levator contraction strength and genital hiatus as risk factors for recurrent pelvic organ prolapse.
      ,
      • Cheung R.Y.K.
      • Lee L.L.L.
      • Chung T.K.H.
      • Chan S.S.C.
      Predictors for dislodgment of vaginal pessary within one year in women with pelvic organ prolapse.
      ], increased gh values are related to prolapse disease. Handa et al. estimated the time to develop prolapse being 33.4 years with persistent gh of 3 cm vs 5.8 years when gh reached ≥ 4.5 cm [
      • Handa V.L.
      • Blomquist J.L.
      • Carroll M.K.
      • Muñoz A.
      Genital Hiatus Size and the development of prolapse among parous women.
      ].
      According to clinical and histological investigations by Haylen et al., vaginal introitus includes all areas distal to the hymen: the anterior and posterior vestibules and the perineum. Vaginal introitus defined as level III represents the lowest level of the vagina [

      Haylen BT, Vu D, Wong A. Surgical anatomy of the vaginal introitus. Neurourol Urodyn. 2022 May 20. doi: 10.1002/nau.24961. Epub ahead of print.

      ]. Findings by Haylen et al. [

      Haylen BT, Vu D, Wong A. Surgical anatomy of the vaginal introitus. Neurourol Urodyn. 2022 May 20. doi: 10.1002/nau.24961. Epub ahead of print.

      ] modify the original cadaver dissection-based definition by DeLancey [
      • DeLancey J.O.L.
      Anatomical aspects of vaginal eversion after hysterectomy.
      ] being consistent with the more recent definition by IUGA and ICS [
      • Haylen B.T.
      • Maher C.F.
      • Barber M.D.
      • Camargo S.
      • Dandolu V.
      • Digesu A.
      • et al.
      An international urogynecological association (IUGA)/international continence society (ICS) joint report on the terminology for female pelvic organ prolapse (POP).
      ]. In our study, gh measurements were taken according to POP-Q. Considering gh being the proximal limit of level III (introitus), a comprehensive description of introitus gaping or narrowing could not be given by gh measures. From a clinical and functional point of view it might be meaningful to standardize measures of vaginal introitus width in addition to gh, correlate such measures and further investigate “vaginal/introitus gaping” and “vaginal/introitus stenosis”. Haylen et al. [
      • Haylen B.T.
      • Avery D.
      • Chiu T.L.
      • Birrell W.
      Posterior repair quantification (PR-Q) using key anatomical indicators (KAI): preliminary report.
      ] introduced a “posterior repair quantification (PR-Q)” terming perineal gap (PG), posterior vaginal vault descent (PVVD), mid-vaginal laxity (MVL-vault undisplaced/displaced), recto-vaginal fascial laxity (RVFL), total posterior vaginal length (TPVL) and from POP-Q, TVL as indicators. Authors recommend such measurements for comparability of vaginal surgery in the posterior compartment. Additionally, the same group introduced and used a perioperative perineorrhaphy assessment (Pe-QA) and presented data of n = 50 consecutive surgeries [
      • Haylen B.T.
      • Younis M.
      • Naidoo S.
      • Birrell W.
      Perineorrhaphy quantitative assessment (Pe-QA).
      ]. Authors took the following measures: perineorrhaphy width (PW; equals PG), perineorrhaphy depth (PD), perineal length (PL), midperineal thickness (MPT), genital hiatus (GH), total vaginal length (TVL) and total posterior vaginal length (TPVL). For future investigations of anatomical and functional outcomes of vaginal surgery in the posterior compartment, it would be of interest to conduct prospective studies including such measurements to comprehensively answer questions on anatomical and functional success of reconstructive surgery in the posterior compartment. Additionally, this would be of interest for comparing surgical approaches and techniques of vaginal native tissue repair.
      Recent MRT studies on surgical anatomy found a strong correlation between Level I and Level III support, the latter being reflected by a wide urogenital hiatus [

      Haylen BT, Vu D, Wong A. Surgical anatomy of the vaginal introitus. Neurourol Urodyn. 2022 May 20. doi: 10.1002/nau.24961. Epub ahead of print.

      ,
      • Cheng W.
      • Thibault M.D.
      • Chen L.
      • DeLancey J.O.L.
      • Swenson C.W.
      Changes in cardinal ligament length and curvature with parity and prolapse and their relation to level III hiatus measures.
      ]. Haylen et al. [

      Haylen BT, Vu D, Wong A, Livingstone S. Surgical anatomy of the mid-vagina. Neurourol Urodyn. 2022 Jun 22. doi: 10.1002/nau.24994. Epub ahead of print.

      ] concluded that surgery concomitantly addressing Level I and Level III repair would limit the need for additional Level II support. This finding seems especially important for future research due to the contribution of Level II to urethral support and the associated functional finding of SUI after some POP procedures. Enlarged gh has been described as a risk factor for recurrent prolapse and as a strong predictor for surgical failure in native tissue repair. Vaughan et al. [
      • Vaughan M.H.
      • Siddiqui N.Y.
      • Newcomb L.K.
      • Weidner A.C.
      • Kawasaki A.
      • Visco A.G.
      • et al.
      Surgical alteration of genital hiatus size and anatomic failure after vaginal vault suspension.
      ] found a 4.4-fold increased recurrence risk after native tissue repair when preoperative gh values of > 4 cm persisted after surgery. Guiahi et al. [
      • Guiahi M.
      • Kenton K.
      • Brubaker L.
      Sacrocolpopexy without concomitant posterior repair improves posterior compartment defects.
      ] found that sacropexy without concomitant vaginal repair restored the posterior anatomy in most cases, with a mean gh value of 31 mm at 1 year postoperatively. This compares to our results achieved with vaginal native-tissue surgery. Guiahi et al. [
      • Guiahi M.
      • Kenton K.
      • Brubaker L.
      Sacrocolpopexy without concomitant posterior repair improves posterior compartment defects.
      ] did not report pb values, preventing comparison with our findings. Further comparison of sacropexy techniques and vaginal surgery with respect to level III support and external genital appearance in patients with introitus dehiscence and the feeling of a wide introitus or vagina would thus be of interest.
      Bradly et al. [
      • Bradley M.S.
      • Askew A.L.
      • Vaughan M.H.
      • Kawasaki A.
      • Visco A.G.
      Robotic-assisted sacrocolpopexy: early postoperative outcomes after surgical reduction of enlarged genital hiatus.
      ] found a 5.3-fold increased risk for early anatomic failure in the posterior compartment after robotic sacropexy with postoperative gh of > 4 cm. Recent research is underlining the importance of perineorrhaphy as concomitant surgical procedure for Level III defect repair in defect specific POP surgery.
      In our study, POP-Q measurements for the assessment of Level III defects were taken directly using a ruler at the vaginal surgical field under anaesthesia and therefore in the absence of straining. This strategy was discussed controversially by some authors. In a recent MRI study on Level III defects, Schmidt et al. found resting rather than straining measures more precisely reflecting the structural pelvic floor support, not being biased by the ability or inability of individual patients to perform Valsalva maneuvers [
      • Schmidt P.
      • Chen L.
      • DeLancey J.O.
      • Swenson C.W.
      Preoperative level II/III MRI measures predicting long-term prolapse recurrence after native tissue repair.
      ]. The comparison of such anatomical measurements with those obtained with perineal ultrasound and/or magnetic resonance imaging would thus be of interest.

      Preoperative gh and pb and parity

      In our cohort, patients who had experienced more than one vaginal delivery had higher gh and lower pb values than did primiparous women. Statistically, our data show an influence of parity on preoperative gh values, but not on preoperative pb values. However, because of low number of patients with four vaginal deliveries, data should be interpreted with caution and larger studies are required. Our results are in line with studies showing parity as a risk factor for POP [
      • Jelovsek J.E.
      • Maher C.
      • Barber M.D.
      Pelvic organ prolapse.
      ,
      • Weemhoff M.
      • Shek K.L.
      • Dietz H.P.
      Effects of age on levator function and morphometry of the levator hiatus in women with pelvic floor disorders.
      ,
      • Barber M.D.
      • Maher C.
      Epidemiology and outcome assessment of pelvic organ prolapse.
      ,
      • Mothes A.R.
      • Radosa M.P.
      • Altendorf-Hofmann A.
      • Runnebaum I.B.
      Risk index for pelvic organ prolapse based on established individual risk factors.
      ] and gh and pb are quantitative parameters used for POP assessment [
      • Bump R.C.
      • Mattiasson A.
      • Bo K.
      • et al.
      The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction.
      ]. Dunivan et al [
      • Dunivan G.C.
      • Lyons K.E.
      • Jeppson P.C.
      • Ninivaggio C.S.
      • Komesu Y.M.
      • Alba F.M.
      • et al.
      Pelvic organ prolapse stage and the relationship to genital hiatus and perineal body measurements.
      ] found parity independently affecting gh and pb values, and that gh (but not pb) values were larger in the parous group for each prolapse stage. Given the lack of nulliparous patients in our cohort, we could not examine the influence of parity in more detail. Normal gh and pb values in adult women without prolapse have not been defined [
      • Sánchez-Ferrer M.L.
      • Prieto-Sánchez M.T.
      • Moya-Jiménez C.
      • et al.
      Anogenital distance and perineal measurements of the pelvic organ prolapse (POP) quantification system.
      ]. Standardised gh values have been found to be larger in patients with POP than in healthy controls (53.7 ± 19.1 vs 44.3 ± 10.3 mm), depending on the history of vaginal deliveries, other obstetric history factors and delivered infants’ birth weight [
      • Sánchez-Ferrer M.L.
      • Prieto-Sánchez M.T.
      • Moya-Jiménez C.
      • et al.
      Anogenital distance and perineal measurements of the pelvic organ prolapse (POP) quantification system.
      ].
      In our investigation, we found mean preoperative gh value in POP was 44 mm, similar to pre–prolapse surgery values reported by other authors including studies on MRI measurements [

      Haylen BT, Vu D, Wong A. Surgical anatomy of the vaginal introitus. Neurourol Urodyn. 2022 May 20. doi: 10.1002/nau.24961. Epub ahead of print.

      ,
      • Cheng W.
      • Thibault M.D.
      • Chen L.
      • DeLancey J.O.L.
      • Swenson C.W.
      Changes in cardinal ligament length and curvature with parity and prolapse and their relation to level III hiatus measures.
      ,
      • Vaughan M.H.
      • Siddiqui N.Y.
      • Newcomb L.K.
      • Weidner A.C.
      • Kawasaki A.
      • Visco A.G.
      • et al.
      Surgical alteration of genital hiatus size and anatomic failure after vaginal vault suspension.
      ,
      • Guiahi M.
      • Kenton K.
      • Brubaker L.
      Sacrocolpopexy without concomitant posterior repair improves posterior compartment defects.
      ]. Other authors found mean preoperative gh values of 36 mm [
      • Dunivan G.C.
      • Lyons K.E.
      • Jeppson P.C.
      • Ninivaggio C.S.
      • Komesu Y.M.
      • Alba F.M.
      • et al.
      Pelvic organ prolapse stage and the relationship to genital hiatus and perineal body measurements.
      ] and 37 mm [
      • Lowder J.L.
      • Oliphant S.S.
      • Shepherd J.P.
      • Ghetti C.
      • Sutkin G.
      Genital hiatus size is associated with and predictive of apical vaginal support loss.
      ] in prolapse. Due to gh measures depending on prolapse stage increasing through stage 3 POP [
      • Dunivan G.C.
      • Lyons K.E.
      • Jeppson P.C.
      • Ninivaggio C.S.
      • Komesu Y.M.
      • Alba F.M.
      • et al.
      Pelvic organ prolapse stage and the relationship to genital hiatus and perineal body measurements.
      ], differences in preoperative gh values of different study cohorts reported in the literature are explained.

      Surgical procedure

      In a survey amongst surgeons, Kanter et al. [
      • Kanter G.
      • Jeppson P.C.
      • McGuire B.L.
      • Rogers R.G.
      Perineorrhaphy: commonly performed yet poorly understood. A survey of surgeons.
      ] found a significant heterogeneity of techniques performed for Level III repair depending on examination. Most surgeons stated to re-approximate bulbocavernosus muscles combined with or without transverse perineal muscles according to intra-operative findings. We think it is important to step by step plan and perform reconstructive surgery according to repeated intra-operative inspection and palpation.
      Recently, Haylen et al. [
      • Haylen B.T.
      • Younis M.
      • Naidoo S.
      • Birrell W.
      Perineorrhaphy quantitative assessment (Pe-QA).
      ] reported 30.8 % reduction of gh and 27.6 % increase in perineal length after perineorrhaphy. Our surgery resulted in a similar gh reduction of 29.5 % and a pb increase of 25.5 %.

      QOL and patients' judgement

      Data on functional outcome of decreased genital hiatus width after surgical reconstruction are sparse. This might be related to the fact that perineorrhaphy is solely performed as a concomitant procedural step at the end of posterior repair if indicated. Therefore, a clear assessment of its direct effect on functional outcome after POP repair remains challenging. We decided to evaluate overall function with regard to quality of life and patient́s satisfaction after POP surgeries that included a Level III repair as concomitant procedural part. Quality of life improvement and patient́s satisfaction should be the main aim of functional, reconstructive surgery in which more than one surgical step contributes to defect specific reconstructions with more than one organ function being affected.
      We observed postoperative reduction of all prolapse symptoms, including improved sexual function in sexually active patients. Reconstructive pelvic floor surgery aims on improving quality of life by restoring anatomy and function. According to this philosophy, we focussed on the assessment of prolapse symptoms related to areas of life. Therefore, the disease specific validated P-QOl/D questionnaire was used [
      • Digesu G.A.
      • Khullar V.
      • Cardozo L.
      • Robinson D.
      • Salvatore S.
      P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse.
      ,
      • Lenz F.
      • Stammer H.
      • Brocker K.
      • Rak M.
      • Scherg H.
      • Sohn C.
      Validation of a German version of the P-QOL Questionnaire.
      ]. Domain 6 (“Personal relationships”) contains questions on partnership and sexual life. In sexually active as well as in sexually inactive patients, domain 6 of P-QOl/D significantly improved after surgery. Other authors reported dyspareunia in 10 % of patients, but did not perform functional evaluation using a validated instrument [
      • Ulubay M.
      • Keskin U.
      • Fidan U.
      • et al.
      Safety, efficiency, and outcomes of perineorrhaphy: treatment of the sensation of a wide vagina.
      ]. Other groups reported postoperative rates of dyspareunia [
      • Abedi P.
      • Jamali S.
      • Tadayon M.
      • Parhizkar M.
      • Mogharab F.
      Effectiveness of selective vaginal tightening on sexual function among reproductive aged women in Iran with vaginal laxity: a quasi-experimental study.
      ,
      • Weber A.
      • Walters M.
      • Piedmonte M.
      Sexual function and vaginal anatomy in women before and after surgery for pelvic organ prolapse and urinary incontinence.
      ]. Our findings do not confirm some pelvic floor therapists’ argument that perineorrhaphy leads to pain and dyspareunia [
      • Ulubay M.
      • Keskin U.
      • Fidan U.
      • et al.
      Safety, efficiency, and outcomes of perineorrhaphy: treatment of the sensation of a wide vagina.
      ,
      • Jeffcoate T.
      Posterior colpoperineorrhaphy.
      ]. Woodward et al. demonstrated improvement of dyspareunia and increased coital frequency after revision perineorrhaphy for postpartum dyspareunia in a small patient cohort [
      • Woodward A.P.
      • Matthews C.A.
      Outcomes of revision perineoplasty for persistent postpartum dyspareunia.
      ]. EGGS results of subjective patients' judgement of cure with a high subjective cure rate of 87 % was similar to other studies on vaginal native tissue prolapse repair [
      • Mothes A.R.
      • Wanzke L.
      • Radosa M.P.
      • Runnebaum I.B.
      Bilateral minimal tension sacrospinous fixation in pelvic organ prolapse: an observational study.
      ].

      Limitations

      Main limitations relate to the study design with potential bias of retrospectivity. A prospective comparative study on outcomes of posterior repair with and without perineorrhaphy would be of interest. Additionally, the majority of pelvic floor defects in which perineorrhaphy was indicated required posterior vaginal repair as well as repair of other concomitant defects. The nature of such combined reconstructive procedures makes the separate functional evaluation of either procedural step difficult. Further limitation relates to questionnaire return rate. Another limitation relates to unavailable data on menopausal status and local vaginal estrogen treatment, which might influence satisfaction with sexual activity.
      The significant improvement in gh achieved with surgery in our study can be interpreted as reflecting anatomical restoration with Level III pelvic-floor support. But functional outcomes mirrored by QOL improvement and patients' satisfaction is the result of the combined performance of multi-compartment repair procedures according to the defect pattern, and thus not attributable solely to perineorrhaphy.

      Summary

      The findings of this study demonstrate that defect-specific native-tissue POP repair surgery including perineorrhaphy successfully repairs the pelvic floor anatomy with special regard to Level III [
      • DeLancey J.
      Structural anatomy of the posterior pelvic compartment as it relates to rectocele.
      ], resulting in lower gh and higher pb values. Postoperatively, the patients reported improvement in all P-QOL/D domains of functional outcome, with no difference between sexually active and inactive patients. The majority of patients in this study reported satisfaction with the surgical outcomes due to partial or full goal achievement, and would recommend the operation to a friend. These results suggest that perineorrhaphy is a necessary technical step in anatomical restoration that does not lead to functional impairment, including the impairment of sexual activity and QOL.

      Data availability

      The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

      Declaration of Competing Interest

      The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

      Acknowledgements

      The authors wish to thank Dr. rer. nat. Thomas Lehmann, Institute of Medical Statistics, Computer and Data Sciences, Jena University Hospital, Friedrich-Schiller-University Jena, Germany, for assistance with statistical analysis.

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