Int Urogynecol J DOI 10.1007/s00192-014-2518-3
REVIEW ARTICLE
A systematic review and meta-analysis of the impact of native tissue repair for pelvic organ prolapse on sexual function Swati Jha & Thomas Gray
Received: 10 June 2014 / Accepted: 13 September 2014 # The International Urogynecological Association 2014
Abstract Introduction and hypothesis The aim of this review was to investigate the impact of native tissue repair for pelvic organ prolapse (POP) on overall sexual function and dyspareunia. Methods Cochrane Incontinence Group Specialized Register of Controlled Trials, The Cochrane Central Register of Controlled Trials, MEDLINE, and Embase were searched for trials of prolapse surgery assessing sexual function and dyspareunia before and after surgery. We assessed observational studies and randomized controlled trials investigating the impact of surgical correction of POP on sexual function. Surgical interventions assessed were anterior and/or posterior repair with or without a vaginal hysterectomy. Studies including patients undergoing concurrent incontinence surgery or vaginal mesh insertion were excluded from the analysis. Dyspareunia was analyzed separately. Results We identified 674 potential citations, of which 14 articles assessed sexual function and/or dyspareunia before and after traditional prolapse surgery. The results suggest evidence for significant improvement in sexual function postsurgery, with a standardized mean difference of −0.55, 95 % confidence interval (CI) −0.68 to −0.43 in favor of surgical correction. Dyspareunia rates were also significantly improved postoperatively, with overall odds ratio of at least 2.5 times as likely as the chances of deterioration. Discussion Sexual function is significantly improved and dyspareunia significantly reduced following native tissue prolapse surgery. There were several methodological problems with the quality of the primary research, particularly related to study heterogeneity, use of different outcome measures, and absence of well-designed randomized controlled trials. S. Jha (*) : T. Gray Department of Urogynaecology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield Teaching Hospitals Level 4 Jessop Wing Tree Root Walk, Sheffield S10 2SF, UK e-mail: [email protected]
Keywords Pelvic organ prolapse . Anterior repair . Posterior repair . Sexual function . Dyspareunia
Introduction Pelvic organ prolapse (POP) is a common problem and affects half [1–4] of all women who have had children, with one in ten needing surgery over the course of their lifetime. POP affects quality of life (QoL) in a number of ways: Novi et al. [5] compared sexual function in women with and without prolapse and found POP to have a significant negative impact on sexual function. Similar results were demonstrated by Barber et al. [6]. The impact of POP surgery on symptomatic improvement of prolapse symptoms have been extensively studied, but less so its impact on other functional symptoms, such as sexual function. Adequate functioning of the vagina for intercourse depends on restoration of anatomy as well as neurovascular factors. Until 10–15 years ago, sexual function was underreported, and the focus was purely on restoration of anatomy and recurrence [7]. Gheilmetti et al.[8] demonstrated that gynecological operations impact significantly on sexual function; however, past measures of sexual function have not been validated and are either retrospective or are relatively small series. In addition, studies analyzing sexual function are difficult to interpret, as different types of POP and incontinence surgery are often clustered, resulting in considerable heterogeneity. It is also now accepted that POP and incontinence surgeries have very different impacts on sexual function [9]. The different studies also use different instruments for assessment, which makes study comparison difficult. The objective of this systematic review was to assess the impact of native tissue repair surgery, namely, anterior and/or posterior repair, for POP on sexual function and dyspareunia.
Int Urogynecol J
Methods
Interventions
A study protocol stating research question, population, intervention, and outcomes, as well as criteria used to select or exclude studies (including the methods used for data extraction and analysis) preceded this systematic review. Guidelines issued by the Meta-analysis of Observational Studies in Epidemiology (MOOSE) [10] Group were adhered to.
The type of interventions included commonly performed traditional procedures for prolapse, i.e., anterior and/or posterior repair either as an individual procedure or in conjunction with a vaginal hysterectomy. These are the most commonly performed procedures for pelvic organ prolapse (POP) [11]. Studies evaluating vaginal mesh procedures or posthysterectomy vault procedures were excluded because such procedures classify as recurrent prolapse, given that the apical compartment had been dealt with vaginally in a significant proportion of these patients. In addition, vaginal mesh procedures are associated with high dyspareunia rates, which would impact results [12]. We also excluded studies that assessed sexual procedure following combination prolapse and incontinence surgery.
Data sources A detailed computerized search was conducted on published literature and inclusive dates from eight databases in March 2013: MEDLINE (1950–2013), Embase (1980–2013), Cochrane Library including Current Controlled Trials Meta Register Cochrane Central Register of Trials (formerly CENTRAL and incorporating the trials register of the Cochrane Incontinence Group), Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects (1991– 2013), Science Citation Index (1900–2013), Social Science Citation Index (1900–2013), Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982–2013), and Medline In-Process & Other Non-Indexed Citations. No date or language restrictions were used. The search strategy used combinations of search terms related to sexual function, interventions for prolapse, and outcomes for sexual function. Search terms related to sexual function were sexual function and dyspareunia. Terms relating to the intervention were anterior repair and posterior repair. Terms related to outcome measures were change, improvement, and deterioration. We searched for trials of prolapse surgery assessing sexual function and dyspareunia before and after surgery. The search was conducted by the Sheffield University School of Health and Related Research (ScHARR).
Study selection We selected studies that reported on sexual function of sexually active women with symptomatic prolapse who underwent surgery. Patients acted as their own controls. Articles that included patients with concurrent incontinence surgery or vaginal mesh procedures were excluded from the review.
Methodological quality assessment Eight studies were randomized trials and the others were cohort studies. Where randomized controlled trials (RCTs) involved mesh versus native tissue repair, we extracted data only from patients with native tissue surgery.
Outcomes The studies varied significantly in the reporting of sexual function. Some studies used a sexual function questionnaire; some reported on the change in overall status, i.e., better, worse, or change; others reported on specific symptoms of sexual function, usually dyspareunia. Questionnaires used included the Prolpase and Incontinence Sexual Function Questionnaire (PISQ-31) and its short form (PISQ-12) [13, 14], Female Sexual Function Index (FSFI) [15], Prolapse Quality of Life (P-QOL) [16], and electronic Pelvic Floor Assessment Questionnaire (ePAQ) [17]. To combine results from the different studies, it was agreed that using a binary outcome—i.e., improvement, no change, or deterioration— was appropriate, as this data could be extracted from all studies, including those that used both validated and nonvalidated questionnaires for assessment of sexual function. Studies that reported on pre- and postoperative data formed part of the meta-analysis. Our objective was to analyze dyspareunia rates separately, as this is a distinct and separate aspect of sexual function independent of overall sexual function. Data extraction and analysis Two authors (SJ and TG) independently screened titles and abstracts extracted from the initial search to determine whether they met inclusion and exclusion criteria. Where there was doubt, the full paper was reviewed. The methodological quality of each study was assessed using the Newcastle–Ottawa scale [18] developed to assess the quality of nonrandomized studies with its design, content, and ease of use directed to the task of incorporating quality assessments in the interpretation of meta-analytic results. This is routinely used in conducting systematic reviews and meta-analysis to assess the quality of the studies included [19, 20]. All relevant raw data were
Int Urogynecol J
extracted from each eligible study by both reviewers independently; disagreements were resolved through verification and discussion. Where necessary, we contacted the researchers to obtain additional information about study methods or outcome measures. Data was transferred to Review Manager (RevMan) 5.0 data analysis tables (Cochrane Collaboration, 2008; The Nordic Cochrane Centre, Copenhagen, Denmark). Overall probability of improvement, no change, and deterioration were calculated for all procedures. For continuous outcomes, i.e., where a questionnaire was used to assess sexual function, a Fig. 1 Literature search and data extraction
standardized mean difference was used. This allowed combining results of the different questionnaires used. For questionnaires that used increasing scales for increasing severity, the direction of the questionnaire was corrected by subtracting the mean from the maximum possible value for the scale. This was to ensure all questionnaires demonstrated improvement and deterioration in the same direction. Dyspareunia as a specific outcome was analyzed separately by determining improvement, no change, or deterioration by comparing pre- and postoperative results using the patients as their own controls.
Total citations identiϐied from initial search (n= 674)
Citations excluded after removing duplicates and screening titles and/or abstracts (n=639)
Potential References reviewed for detailed evaluation (n =56) (35 from initial search and 21 identiϐied after screening these)
Excluded studies (n =41) Reason for exclusion Review = 12 Included incontinence/other procedures = 12 Insufϐicient data = 16 Withdrawn= 1
Studies included in the Review (n =15)
Hasse et al. 1988 [18]
Colombo et al. 2000 [17]
Weber et al2001 [26]
Nieminen et al. 2004 [29]
Paraiso et al. 2006 [23]
Novi et al. 2007 [30]
Pauls et al. 2007 [16]
Azar et al. 2008 [20]
Fayyad et al. 2008 [31]
Altman et al. 2011 [21]
Vollebregt et al. [25]
Milani et al. 2011 [22]
Dua et al. 2012 [19]
Sokol et al. 2012 [24]
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Inclusion: Vaginal Prolapse; Exclusion: Continence surgery; Age Mean: 36.03; Parity: 3.96 Operative success: Not stated Inclusion: Vaginal Prolapse; Exclusion: Continence surgery; Age Mean: 63 Parity: 2.5; Operative success: 76.5 % Inclusion: Vaginal Prolapse; Exclusion: Continence surgery; Age Mean: 65.1; Parity: 2 Operative success: 62.1 % Inclusion: Vaginal Prolapse; Exclusion: Continence surgery; Age Mean: 59; Parity: 2.7; Operative success: 91 % Inclusion: Vaginal Prolapse; Exclusion: Continence surgery; Age Mean: 62; Parity: 2; Operative success: 100 % Inclusion: Vaginal Prolapse; Exclusion: Continence surgery; Age: 57.2; Parity: Not Stated; Operative success: Significant improvement (p
REVIEW ARTICLE
A systematic review and meta-analysis of the impact of native tissue repair for pelvic organ prolapse on sexual function Swati Jha & Thomas Gray
Received: 10 June 2014 / Accepted: 13 September 2014 # The International Urogynecological Association 2014
Abstract Introduction and hypothesis The aim of this review was to investigate the impact of native tissue repair for pelvic organ prolapse (POP) on overall sexual function and dyspareunia. Methods Cochrane Incontinence Group Specialized Register of Controlled Trials, The Cochrane Central Register of Controlled Trials, MEDLINE, and Embase were searched for trials of prolapse surgery assessing sexual function and dyspareunia before and after surgery. We assessed observational studies and randomized controlled trials investigating the impact of surgical correction of POP on sexual function. Surgical interventions assessed were anterior and/or posterior repair with or without a vaginal hysterectomy. Studies including patients undergoing concurrent incontinence surgery or vaginal mesh insertion were excluded from the analysis. Dyspareunia was analyzed separately. Results We identified 674 potential citations, of which 14 articles assessed sexual function and/or dyspareunia before and after traditional prolapse surgery. The results suggest evidence for significant improvement in sexual function postsurgery, with a standardized mean difference of −0.55, 95 % confidence interval (CI) −0.68 to −0.43 in favor of surgical correction. Dyspareunia rates were also significantly improved postoperatively, with overall odds ratio of at least 2.5 times as likely as the chances of deterioration. Discussion Sexual function is significantly improved and dyspareunia significantly reduced following native tissue prolapse surgery. There were several methodological problems with the quality of the primary research, particularly related to study heterogeneity, use of different outcome measures, and absence of well-designed randomized controlled trials. S. Jha (*) : T. Gray Department of Urogynaecology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield Teaching Hospitals Level 4 Jessop Wing Tree Root Walk, Sheffield S10 2SF, UK e-mail: [email protected]
Keywords Pelvic organ prolapse . Anterior repair . Posterior repair . Sexual function . Dyspareunia
Introduction Pelvic organ prolapse (POP) is a common problem and affects half [1–4] of all women who have had children, with one in ten needing surgery over the course of their lifetime. POP affects quality of life (QoL) in a number of ways: Novi et al. [5] compared sexual function in women with and without prolapse and found POP to have a significant negative impact on sexual function. Similar results were demonstrated by Barber et al. [6]. The impact of POP surgery on symptomatic improvement of prolapse symptoms have been extensively studied, but less so its impact on other functional symptoms, such as sexual function. Adequate functioning of the vagina for intercourse depends on restoration of anatomy as well as neurovascular factors. Until 10–15 years ago, sexual function was underreported, and the focus was purely on restoration of anatomy and recurrence [7]. Gheilmetti et al.[8] demonstrated that gynecological operations impact significantly on sexual function; however, past measures of sexual function have not been validated and are either retrospective or are relatively small series. In addition, studies analyzing sexual function are difficult to interpret, as different types of POP and incontinence surgery are often clustered, resulting in considerable heterogeneity. It is also now accepted that POP and incontinence surgeries have very different impacts on sexual function [9]. The different studies also use different instruments for assessment, which makes study comparison difficult. The objective of this systematic review was to assess the impact of native tissue repair surgery, namely, anterior and/or posterior repair, for POP on sexual function and dyspareunia.
Int Urogynecol J
Methods
Interventions
A study protocol stating research question, population, intervention, and outcomes, as well as criteria used to select or exclude studies (including the methods used for data extraction and analysis) preceded this systematic review. Guidelines issued by the Meta-analysis of Observational Studies in Epidemiology (MOOSE) [10] Group were adhered to.
The type of interventions included commonly performed traditional procedures for prolapse, i.e., anterior and/or posterior repair either as an individual procedure or in conjunction with a vaginal hysterectomy. These are the most commonly performed procedures for pelvic organ prolapse (POP) [11]. Studies evaluating vaginal mesh procedures or posthysterectomy vault procedures were excluded because such procedures classify as recurrent prolapse, given that the apical compartment had been dealt with vaginally in a significant proportion of these patients. In addition, vaginal mesh procedures are associated with high dyspareunia rates, which would impact results [12]. We also excluded studies that assessed sexual procedure following combination prolapse and incontinence surgery.
Data sources A detailed computerized search was conducted on published literature and inclusive dates from eight databases in March 2013: MEDLINE (1950–2013), Embase (1980–2013), Cochrane Library including Current Controlled Trials Meta Register Cochrane Central Register of Trials (formerly CENTRAL and incorporating the trials register of the Cochrane Incontinence Group), Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects (1991– 2013), Science Citation Index (1900–2013), Social Science Citation Index (1900–2013), Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982–2013), and Medline In-Process & Other Non-Indexed Citations. No date or language restrictions were used. The search strategy used combinations of search terms related to sexual function, interventions for prolapse, and outcomes for sexual function. Search terms related to sexual function were sexual function and dyspareunia. Terms relating to the intervention were anterior repair and posterior repair. Terms related to outcome measures were change, improvement, and deterioration. We searched for trials of prolapse surgery assessing sexual function and dyspareunia before and after surgery. The search was conducted by the Sheffield University School of Health and Related Research (ScHARR).
Study selection We selected studies that reported on sexual function of sexually active women with symptomatic prolapse who underwent surgery. Patients acted as their own controls. Articles that included patients with concurrent incontinence surgery or vaginal mesh procedures were excluded from the review.
Methodological quality assessment Eight studies were randomized trials and the others were cohort studies. Where randomized controlled trials (RCTs) involved mesh versus native tissue repair, we extracted data only from patients with native tissue surgery.
Outcomes The studies varied significantly in the reporting of sexual function. Some studies used a sexual function questionnaire; some reported on the change in overall status, i.e., better, worse, or change; others reported on specific symptoms of sexual function, usually dyspareunia. Questionnaires used included the Prolpase and Incontinence Sexual Function Questionnaire (PISQ-31) and its short form (PISQ-12) [13, 14], Female Sexual Function Index (FSFI) [15], Prolapse Quality of Life (P-QOL) [16], and electronic Pelvic Floor Assessment Questionnaire (ePAQ) [17]. To combine results from the different studies, it was agreed that using a binary outcome—i.e., improvement, no change, or deterioration— was appropriate, as this data could be extracted from all studies, including those that used both validated and nonvalidated questionnaires for assessment of sexual function. Studies that reported on pre- and postoperative data formed part of the meta-analysis. Our objective was to analyze dyspareunia rates separately, as this is a distinct and separate aspect of sexual function independent of overall sexual function. Data extraction and analysis Two authors (SJ and TG) independently screened titles and abstracts extracted from the initial search to determine whether they met inclusion and exclusion criteria. Where there was doubt, the full paper was reviewed. The methodological quality of each study was assessed using the Newcastle–Ottawa scale [18] developed to assess the quality of nonrandomized studies with its design, content, and ease of use directed to the task of incorporating quality assessments in the interpretation of meta-analytic results. This is routinely used in conducting systematic reviews and meta-analysis to assess the quality of the studies included [19, 20]. All relevant raw data were
Int Urogynecol J
extracted from each eligible study by both reviewers independently; disagreements were resolved through verification and discussion. Where necessary, we contacted the researchers to obtain additional information about study methods or outcome measures. Data was transferred to Review Manager (RevMan) 5.0 data analysis tables (Cochrane Collaboration, 2008; The Nordic Cochrane Centre, Copenhagen, Denmark). Overall probability of improvement, no change, and deterioration were calculated for all procedures. For continuous outcomes, i.e., where a questionnaire was used to assess sexual function, a Fig. 1 Literature search and data extraction
standardized mean difference was used. This allowed combining results of the different questionnaires used. For questionnaires that used increasing scales for increasing severity, the direction of the questionnaire was corrected by subtracting the mean from the maximum possible value for the scale. This was to ensure all questionnaires demonstrated improvement and deterioration in the same direction. Dyspareunia as a specific outcome was analyzed separately by determining improvement, no change, or deterioration by comparing pre- and postoperative results using the patients as their own controls.
Total citations identiϐied from initial search (n= 674)
Citations excluded after removing duplicates and screening titles and/or abstracts (n=639)
Potential References reviewed for detailed evaluation (n =56) (35 from initial search and 21 identiϐied after screening these)
Excluded studies (n =41) Reason for exclusion Review = 12 Included incontinence/other procedures = 12 Insufϐicient data = 16 Withdrawn= 1
Studies included in the Review (n =15)
Hasse et al. 1988 [18]
Colombo et al. 2000 [17]
Weber et al2001 [26]
Nieminen et al. 2004 [29]
Paraiso et al. 2006 [23]
Novi et al. 2007 [30]
Pauls et al. 2007 [16]
Azar et al. 2008 [20]
Fayyad et al. 2008 [31]
Altman et al. 2011 [21]
Vollebregt et al. [25]
Milani et al. 2011 [22]
Dua et al. 2012 [19]
Sokol et al. 2012 [24]
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Inclusion: Vaginal Prolapse; Exclusion: Continence surgery; Age Mean: 36.03; Parity: 3.96 Operative success: Not stated Inclusion: Vaginal Prolapse; Exclusion: Continence surgery; Age Mean: 63 Parity: 2.5; Operative success: 76.5 % Inclusion: Vaginal Prolapse; Exclusion: Continence surgery; Age Mean: 65.1; Parity: 2 Operative success: 62.1 % Inclusion: Vaginal Prolapse; Exclusion: Continence surgery; Age Mean: 59; Parity: 2.7; Operative success: 91 % Inclusion: Vaginal Prolapse; Exclusion: Continence surgery; Age Mean: 62; Parity: 2; Operative success: 100 % Inclusion: Vaginal Prolapse; Exclusion: Continence surgery; Age: 57.2; Parity: Not Stated; Operative success: Significant improvement (p
