Sacrospinous ligament fixation versus Elevate Posterior procedure in treatment of primary prolapse.

Sacrospinous fixation versus Elevate Posterior procedure in treatment of primary apical compartment prolapse stage >= 2: a multi-center randomised controlled trial.



Rationale:

Pelvic organ prolapse is a common health problem, with a life time risk to undergo surgery of 11%. When dealing with an apical compartment prolapse the most frequent proposed procedure is sacrospinous ligamant fixation, but recently a mesh procedure (Elevate Posterior) was introduced. Although mesh is not recommended as primary procedure based on objectified adverse effects like exposure, pelvic pain and dyspareunia, there is theoretical basis to believe that for apical prolapse, Elevate Posterior is beneficial compared to native tissue repair. We propose a multi-center RCT comparing sacropinous ligament fixation to Elevate Posterior in primary apical compartment prolapse.



Objective:

To compare the effects of sacrospinous ligament fixation versus Elevate Posterior procedure on pelvic floor function.



Study design:

A multi-center, randomised, controlled trial.



Study population:

Inclusion criteria: sexually active women with apical compartment prolapse stage >= 2 requiring surgical treatment. Exclusion criteria: previous prolapse surgery and enterocele stage >= 2 after hysterectomy.



Intervention:

Elevate Posterior or sacrospinous ligament fixation.



Main study parameters/endpoints:

Primary outcome: sexual function at one year after intervention measured using the PISQ-12. Secondary outcomes: POP-Q, morbidity (including post-operative pain, complications and recovery of normal daily activities), disease specific and generic quality of life, repeated pelvic floor surgery within 12 months after intervention and cost analysis.



Sample size calculation:

A difference of 10% from the maximum PISQ score (maximum score is 48, 10% being 4.8) was considered to be clinical relevant. To detect a difference in means of 4,8, with a power of 90% and an alpha level of 0.05, 42 patients in each group are needed. Anticipating on a 15% drop-out rate, we intend to include 100 patients (50 patients in each arm)



Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

As we compare two strategies that are already applied in current clinical practice, no additional risks from both procedures are expected. Evaluation will take place after 6 weeks (routine post-operative consultation), by telephone after 6 months and patients will be invited for one extra visit to the hospital at 12 months (in some hospitals also a routine post-operative consultation).

Pelvic organ prolapse is a common health problem, with a life time risk to undergo surgery of 11%. When dealing with an apical compartment prolapse the most frequent proposed procedure is sacrospinous ligamant fixation, but recently a mesh procedure (Elevate Posterior) was introduced. Although mesh is not recommended as primary procedure based on objectified adverse effects like exposure, pelvic pain and dyspareunia, there is theoretical basis to believe that for apical prolapse, Elevate Posterior is beneficial compared to native tissue repair. We propose a multi-center RCT comparing sacropinous ligament fixation to Elevate Posterior in primary apical compartment prolapse.

Primary endpoint:

To compare the effects of sacrospinous ligament fixation to Elevate Posterior on sexual function measured using the PISQ-12 one year after intervention.

The PISQ-12 is a 12-item questionnaire with responses measured on a 5-point Likert scale, which evaluates sexual function of women with UI or POP and is divided into 3 domains: Behavioral Emotive, Physical, and Partner- Related. The Behavioral Emotive domain evaluates sexual desire, frequency of sexual activity, and orgasmic capabilities, whereas the Physical domain assesses more directly the effect of UI on sexual function. The Partner-Related domain assesses the patient’s perception of her partner’s response to the effect of her pelvic floor disorder on their sexual functioning, as well as her partner’s sexual functioning.



Secondary endpoints:

1. Objective cure. Anatomical outcome will be be assessed by a POP-Q test pre- en postoperatively. A recurrence is defined as POP-Q stage 2 or more;

2. Pain, hospital stay, post- operative recovery. During hospitalisation till the first 6 weeks after surgery all patients are asked to keep a diary. Documented in this diary are: post-operative pain score (measured by the Visual Analogue Scale, on the evening after operation and then daily until the 7th day post-operative and then at 2 weeks and 6 weeks post-operative), used pain medication (daily from day 1 till 7 days post-operative and thereafter at 2 weeks and 6 weeks post-operative), general daily functioning (pre-operative and 1, 2 and 6 weeks post-operative) and number of days from operation till recovery to normal daily activities. After 6 weeks patients will receive a second diary in which they will document all visits to the hospital or physiotherapist because of complications or complaints related to the operation. The used pain medication during hospitalisation will be documented by the patient together with the nurse caring for the patient. Administration of morfine is finished as soon as possible and patients will use paracetamol and/or diclofenac. Used pain medication will be documented in the diary;

3. Subjective outcome will be assessed by validated disease-specific quality of life questionnaires (UDI, DDI, IIQ) and for the cost analysis general quality of life will be assessed by a standardized general quality of life questionnaire (EQ-5). These questionnaires will be filled in pre-operative and 6 weeks and 12 months post-operative;

4. Complications. The following complications will be registered: injury of bladder, bowel, nerve, vessel; buttock pain, haemorrhage/haematoma requiring transfusion and/or surgical intervention, urinary tract infection, retention bladder, fever or infection requiring antibiotics;

5. Repeated surgery within 12 months after intervention will be registered.

Elevate Posterior or sacrospinous ligament fixation.